Needs Assessment: This article aims to educate others who are less familiar with the psychosocial care needs of pediatric hematology/oncology populations. The article provides a description of multidisciplinary collaborations within the same program in contrast to services accessible to this population via outside referrals.

Learning Objectives:
• List issues that arise for children with chronic illness.
• Understand the steps required for organizing a multidisciplinary approach to psychosocial care.
• Ask questions about how children and families can be best served in outpatient clinics.

Target Audience: Primary care physicians and psychiatrists.


CME Accreditation Statement:
This activity has been planned and implemented in accordance with the Essentials and Standards of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the Mount Sinai School of Medicine and MBL Communications, Inc. The Mount Sinai School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.


Credit Designation:
The Mount Sinai School of Medicine designates this educational activity for a maximum of 3 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Faculty Disclosure Policy Statement: It is the policy of the Mount Sinai School of Medicine to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material.

This activity has been peer-reviewed and approved by Eric Hollander, MD, chair and professor of psychiatry at the Mount Sinai School of Medicine, and Norman Sussman, MD, editor of Primary Psychiatry and professor of psychiatry at New York University School of Medicine. Review Date: June 4, 2008.

Drs. Hollander and Sussman report no affiliation with or financial interest in any organization that may pose a conflict of interest.

To receive credit for this activity: Read this article and the two CME-designated accompanying articles, reflect on the information presented, and then complete the CME posttest and evaluation. To obtain credits, you should score 70% or better. Early submission of this posttest is encouraged: please submit this posttest by July 1, 2010 to be eligible for credit. Release date: July 1, 2008. Termination date: July 31, 2010. The estimated time to complete all three articles and the posttest is 3 hours.

Primary Psychiatry. 2008;15(7):63-67

 

Dr. Cruz-Arrieta is senior psychologist and clinical assistant professor in both the Departments of Child & Adolescent Psychiatry and Pediatrics at the New York University (NYU) School of Medicine in New York City. Ms. Weinshank is licensed clinical social worker in the Social Work Department at NYU Langone Medical Center.
Disclosure: The authors report no affiliation with or financial interest in any organization that might pose a conflict of interest.

Please direct all correspondence to: Eduvigis Cruz-Arrieta, PhD, Stephen D. Hassenfeld Children’s Center for Cancer and Blood Disorders, 160 E 32nd St, Second Floor, New York, NY 10016; Tel: 212-263-9925; Fax: 212-263-8410; E-mail: Eduvigis.cruz-arrieta@nyumc.org.

 


 

 

Abstract

Scientific advances that lead to early detection and treatment of childhood illnesses once fatal to most children have contributed to higher survival rates. This article outlines a model used at the Stephen D. Hassenfeld Children’s Center for Cancer and Blood Disorders for providing outpatient cancer and hematology treatments facilitated and supported by allied health professionals. Coping is sometimes compromised by biopsychosocial factors present in the lives of patients prior to illness. Allied health professionals help patients and families cope by providing a supportive environment for the child with a chronic illness and his or her family. A multidisciplinary team approach is illustrated in this article. The authors describe the process of creating a pathway toward holistic care for all patients, from designing tools that integrate basic information about each patient ‘“in context’’ to how this is accomplished. Two case examples of collaboration between disciplines are provided. Finally, ideas on the need for research that demonstrates the benefits of psychosocial interventions and the need for dissemination of information about what works within the pediatric, allied health, and mental health professions are offered.

 

Introduction

The Stephen D. Hassenfeld Children’s Center for Cancer and Blood Disorders (SDHCC) of New York University Langone Medical Center functions both as a day hospital and an outpatient medical facility for children with cancer and blood disorders. It provides modern medical treatments facilitated and supported by allied health professionals. The last 30 years have witnessed scientific advances that led to earlier detection and treatment of childhood illnesses once fatal for most children. For example, the 5-year survival rate in pediatric cancer is approximately 80%, resulting in a continuously growing population of childhood cancer survivors. Data collected in the last 10 years shows ≥270,000 survivors of childhood cancer in the United States. One in 1,000 individuals is a childhood cancer survivor. Demographics of the childhood cancer survivors in the US show that while 33% of these survivors are <20 years of age, 46% are 20–40 years of age, and an additional 18% are >40 years of age.1

Children affected with blood disorders such as sickle cell anemia are transitioning into longer, productive lives with significantly less impairment than before thanks to transfusion and oral medication therapies. However, despite the development of promising future cures through procedures such as bone marrow transplants and gene therapies, inadequate attention to psychological, social, and interpersonal functioning is still present.2 Along with these changes, the need for supportive services (ie, nursing and medical teams) for children, families, and caregivers coping with a chronic, life-threatening illness have evolved in specialized ways to further them.3 In the 1990s, changes in health care led to a reduction of available psychosocial services because they were perceived as expensive and “less essential than other evaluations and interventions.”4

Most people who experience a chronic and/or life-threatening disease cope adequately with the stressors it brings. However, this is not an easy task. For a smaller number of patients and families, their coping is compromised by biopsychosocial factors present in their lives prior to the illness (eg, financial difficulties, psychological disorders). Child life, creative arts therapies, family health librarian, pastoral care, psychology, recreation and rehabilitation therapies, and social work, along with the newly integrated complementary therapies, including mind/body techniques such as aromatherapy, acupuncture/acupressure, dance-movement therapies, herbalism, hypnotherapy, therapy massage, music, Reiki, and yoga, now offer tools and support focused on the needs of ill children and survivors of childhood diseases. These therapeutic activities provide children with age-appropriate ways to identify and discuss numerous feelings associated with treatment.4

The SDHCC’s allied health professional staff, comprised by the disciplines outlined above, is dedicated to providing a positive, nurturing, and supportive environment for children with a chronic illness and their families. This psychosocial team focuses on helping children gain and maintain developmental skills during their illness, hospitalization, and treatment.4 At the SDHCC, the family health librarian is a member of the psychosocial team that participates in clinical discussions. This is anchored in the understanding of these professionals’ contribution to the therapeutic needs of patients and families via their input, selection, and recommendations of bibliotherapy resources. Similarly, pastoral care services that address the spiritual and religious needs of patients and families are a core component of the group’s work (S. Harding, personal communication, August 2007).

Both the quality of patients and parents’ perception of the support received and their individual reactions at the time of diagnosis determines the experience at different stages of medical treatment. It colors their transition out of treatment. The authors believe that a multidisciplinary team approach3,5-7 is essential, as they describe the process of creating a pathway toward holistic care for all patients from the designing of tools that integrate basic information about each patient “in context” to how they accomplish this. Two examples of collaboration between disciplines are offered. The authors hope that these practices lead to well-adjusted survivors of childhood cancer.4

 

Pathway

In an effort to fine-tune the available therapeutic offerings, as well as keep a finger on the pulse of the team’s professional interests and potential contributions, periodic meetings focusing on program planning were organized with administrative leadership. A survey that combined feedback from parents and staff was designed and conducted, and its results were compiled by a social work trainee. The results were incorporated into an in-service presentation for all staff to assist with program planning. How patients and their families moved from the point of diagnosis to participation in active treatment was reviewed.

 

Assessment

The SDHCC’s social workers obtained various tools already in use in similar local hospital settings. One model was selected and adapted for the author’s purposes in a series of multidisciplinary reviews. The authors examined its ease of use, whether it built-in basic relevant information regarding each child, its cultural relevancy, and the inclusion of all professionals needed for child-in-context services. The clinic’s manager consulted with hospital administration concerning the viability of the document draft and the protocol for approval.

 

The Process of Meeting New Patients

The tool adaptation was followed with a review of communication pathways, starting from the moment patients enter the medical center’s system to their first visit to the clinic (Table 1).

 

The psychosocial rounds forum is a meeting in which high-risk issues are identified from the initial interview and impressions and concerns are articulated. The main objectives are to design a multidisciplinary care plan for patients and caregivers, discuss in greater detail relevant psychosocial/behavioral health issues, prepare to follow up with those issues by presenting them at our Interdisciplinary Medical Rounds, and address urgent issues or emergencies. In addition, this meeting serves as a forum for program planning and administrative problem-solving related to services provided to patients.

The standard procedure for case discussions begins with soliciting patients’ names and topics from all medical/psychosocial staff in advance to generate a list for discussion. Urgent issues are addressed first, followed by newly diagnosed patients and a review of ongoing cases. For new patients, a care plan is designed. For existing patients, the care plan is periodically reviewed.

A summary of the discussion is shared with all faculty and staff in medical rounds. The patient’s chart, psychosocial assessment form (excerpted in Table 2), and psychosocial treatment planning form (excerpted in Table 3) are used to guide the psychosocial discussion.

 

 

 

This form is completed by the social workers after completing three meetings with a new patient and his or her family. Table 2 contains examples of basic psychosocial information included in the form. The information collected is shared with the team. When a patient is referred to other disciplines, this is noted in the “professional collaboration” section. The form is stored in the patients’ medical record. From there on, all pertinent allied healthcare providers document psychosocial interventions in the progress notes section of the medical record.

Table 3 shows a section of the treatment planning form used to organize the psychosocial care plan. Not shown are the list of all disciplines available to work with each child and the short- as well as long-term goals section. This form is brought to the psychosocial rounds and used as part of the treatment planning for the patient. After the initial psychosocial assessment is discussed, the patient is referred to other disciplines if not previously done. The date of the referral is noted, and the form is filed in the patients’ medical record. As each team member meets with the patient or after interventions are completed, these are noted and dated in the form. A full progress note is then added to medical record explaining the intervention.

Patients’ care can be brought up by any staff member whenever issues arise. The following cases, concerning Linnea and Beth, provide a general view of how these routine procedures work.

 

Case Examples

Case 1: Linnea

Linnea, a 7-year-old female recently diagnosed with medulloblastoma, was left visually impaired after having emergency brain surgery prior to beginning treatment. Her vision loss was not discovered until after she began her chemotherapy and radiation protocol. Linnea presented as a shy, quiet child who did not interact much with psychosocial or medical staff. Her mother was constantly tearful but was not forthcoming in discussing these feelings with staff. The psychosocial team was introduced to Linnea and her mother with the goal of ameliorating the crisis of a diagnosis of pediatric brain cancer and the medical crisis of losing part of her vision. Linnea responded well to social work and art therapy staff. Ongoing sessions were arranged where Linnea could produce artwork that helped her express her feelings regarding her diagnosis. Linnea also used imaginative play therapy to cope with painful medical procedures and long hours of receiving chemotherapy. (A general description of these interventions can be found elsewhere.)8

Linnea’s mother met with the psychologist who assisted her in understanding how to help her daughter and other members of the family during this difficult time. In addition, the psychologist helped her figure out the extent of Linnea’s vision difficulties prior to her diagnosis. Linnea’s mother had expressed some guilt about whether there had been signs no one had noticed. Linnea’s decreased appetite and weight loss were also discussed, and her participation in creating a simple, palatable menu was encouraged. Various members of the team also worked with Linnea’s 8-year-old brother, Mike, who has a love of theatre and music. The music therapist succeeded in introducing music as the modality in which he could express his feelings surrounding his sister’s illness. This shows how easily psychosocial care extends to the whole family unit when the patient’s treatment is provided in context and services are available to address the different needs of its members.

Midway through Linnea’s treatment, eating issues became a concern. The psychosocial team was consulted again. The psychologist met with her mother to assess the reasons for Linnea’s appetite issues and to monitor possible mood changes secondary to her medical conditions. Consultations with the inpatient unit team and a consultation/liaison pediatric psychiatrist followed. Linnea’s social worker began to engage her in an age-appropriate manner in order to better understand why she was not eating. A plan to restructure Linnea’s meal times with parental assistance was devised and, in this way, the placement of a feeding tube was avoided. This was a temporary solution as the team is still trying to find out the best way to help her. The medical and psychosocial teams continue to collaborate to support this family through their battle with pediatric cancer.

 

Case 2: Beth

Beth is 8 years of age and was recently diagnosed with acute lymphocytic leukemia. Beth lives with her parents in a New York suburb. Her grandmother, who was her primary caregiver, also lives near the family. There were initial identified issues, including conflict within the family regarding caregiving and Beth’s anxiety toward medical procedures. Beth’s social worker spent time speaking with both the parents and the grandmother reviewing caregiving details. Beth’s mother had previously worked long hours and the grandmother had cared for her. Since diagnosis, the mother had stopped working and began to care for Beth full time. Role changes are often seen in families due to a medical diagnosis, as priorities change for all members of the family when faced with life-threatening circumstances. The mother expressed guilt over her not being able to spend time with Beth prior to her diagnosis. The grandmother felt distant from the family now that the mother was increasingly active with Beth’s daily care.

Team members directly working with the family assisted with creating a schedule for Beth’s care with which all members felt comfortable. They addressed the mother’s feelings of guilt and helped the grandmother feel comfortable with the new limitations on her caregiving role. The psychologist worked with them on basic parenting strategies such as relaxation techniques to decrease Beth’s anxieties. In addition, the expertise of Beth’s nurse for identifying medication strategies was incorporated to help the patient manage her anxieties before spinal taps in the event that non-pharmacologic strategies were not enough.

Both the music and art therapists contributed to Beth’s care by providing a multimodal intervention to calm her medical procedures anxieties. Family issues that are still impacting Beth’s treatment experience in the clinic continued to be addressed with the help of the team’s psychologist on an “as-needed” basis.

 

Conclusion

Psychosocial issues related to the treatment of pediatric illness have been given more attention in recent years.5,9-11 The authors believe that their interdisciplinary team model allows for the most comprehensive psychosocial care of patients and their families. They attempt to identify issues at an early stage and coordinate psychosocial care in a manner that alleviates some of the stressors associated with pediatric illnesses. Their team aims to enhance the quality of life of all patients and families treated at SDHCC.

Future directions of this effort include conducting research to demonstrate the benefits of psychosocial interventions. More information is needed on the existing benefits of the services provided formally and informally at the facility. Who benefits from what? Which interventions are prioritized by the families? Requesting and incorporating feedback from each family on how they and their child benefited from various psychosocial interventions will help refine the work.

The authors intend to compile a psychosocial care manual based on the practice model as well as that of other centers in the US and abroad. Its goal is to provide a map to make the provision of modern medical treatments facilitated and supported by allied health professionals an essential part of any center’s mission. Such models have been designed before3 but are not readily available; others require updated information on how to provide services that fit the needs of families living in complex social contexts with cultural, financial, political, educational, and spiritual12 challenges that are part of living with cancer and other chronic childhood diseases. This manual will offer basic principles of psychosocial care, as well as general interventions that can be implemented by different disciplines either collaboratively or individually. It will also include specialized modules for patients and families at higher risk of having more difficulties with the experience of diagnosis and treatment. Dissemination of information about what works for the authors within the pediatric, allied health, and mental health professions will follow. The poet Maya Angelou said, “Children’s talent to endure stems from their ignorance of alternatives.”13 Primary care physicians can help them endure less and cope more successfully by their knowing what works and creating better alternatives. PP

 

References

1. Bhatia S. Cancer survivorship–pediatric issues. Hematology Am Soc Hematol Educ Program. 2005;507-515.
2. Edwards CL, Scales MT, Loughlin C, et al. A brief review of the pathophysiology, associated pain, and psychosocial issues in sickle cell disease. Int J Behav Med. 2005;12(3):171-179.
3. Kusch M, Labouvie H, Ladisch V, Fleischhack G, Bode U. Structuring psychosocial care in pediatric oncology. Patient Educ Couns. 2000;40(3):231-245.
4. Kazak AE, Cant MC, Jensen MM, et al. Identifying psychosocial risk indicative of subsequent resource use in families of newly diagnosed pediatric oncology patients. J Clin Oncol. 2003;21(17):3220-3225.
5. Hicks MD, Lavender R. Psychosocial practice trends in pediatric oncology. J Pediatr Oncol Nurs. 2001; 18(4):143-153.
6. Creagan ET. Psychosocial issues in oncologic practice. Mayo Clin Proc. 1993;68(2):161-167.
7. Kaufman KL, Harbeck C, Olson R, Nitschke R. The availability of psychosocial interventions to children with cancer and their families. Child Health Care. 1992;21(1):21-25.
8. Nesbitt LL, Tabatt-Haussmann K. The role of the creative arts therapies in the treatment of pediatric hematology and oncology patients. Primary Psychiatry. 2008;15(7):56-58,61-62.
9. Mitchell W, Clarke S, Sloper P. Survey of psychosocial support provided by UK paediatric oncology centres. Arch Dis Child. 2005;90(8):796-800.
10. Waters EB, Wake MA, Hesketh KD, Ashley DM, Smibert E. Health-related quality of life of children with acute lymphoblastic leukaemia: comparisons and correlations between parent and clinician reports. Int J Cancer. 2003;103(4):514-518.
11. Ljungman G, McGrath PJ, Cooper E, et al. Psychosocial needs of families with a child with cancer. J Pediatr Hematol Oncol. 2003;25(3):223-231.
12. Harrison MO, Edwards CL, Koenig HG, Bosworth HB, Decastro L, Wood M. Religiosity/spirituality and pain in patients with sickle cell disease. J Nerv Ment Dis. 2005;193(4):250-257.
13. Angelou M. I Know Why the Caged Bird Sings. 1st ed. New York, NY: Random House; 1969.

 

Needs Assessment: This article aims to educate others on the application of a pill-swallowing training protocol for children with cancer. It describes the main points of the training and the role of adequate parental training via brief vignettes.

Learning Objectives:
• Describe general issues with pill-swallowing training for young children.
• List helpful suggestions for parents of children learning how to swallow pills.
• Understand the role of parents in their children’s learning this skill.

Target Audience: Primary care physicians and psychiatrists.


CME Accreditation Statement:
This activity has been planned and implemented in accordance with the Essentials and Standards of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the Mount Sinai School of Medicine and MBL Communications, Inc. The Mount Sinai School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation: The Mount Sinai School of Medicine designates this educational activity for a maximum of 3 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Faculty Disclosure Policy Statement: It is the policy of the Mount Sinai School of Medicine to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material.

This activity has been peer-reviewed and approved by Eric Hollander, MD, chair and professor of psychiatry at the Mount Sinai School of Medicine, and Norman Sussman, MD, editor of Primary Psychiatry and professor of psychiatry at New York University School of Medicine. Review Date: June 4, 2008.

Drs. Hollander and Sussman report no affiliation with or financial interest in any organization that may pose a conflict of interest.

To receive credit for this activity: Read this article and the two CME-designated accompanying articles, reflect on the information presented, and then complete the CME posttest and evaluation. To obtain credits, you should score 70% or better. Early submission of this posttest is encouraged: please submit this posttest by July 1, 2010 to be eligible for credit. Release date: July 1, 2008. Termination date: July 31, 2010. The estimated time to complete all three articles and the posttest is 3 hours.

Primary Psychiatry. 2008;15(7):49-53

 

Dr. Cruz-Arrieta is senior psychologist and clinical assistant professor in both the Departments of Child & Adolescent Psychiatry and Pediatrics at New York University School of Medicine in New York City.

Disclosure: Dr. Cruz-Arrieta reports no affiliation with or financial interest in any organization that may pose a conflict of interest.

Please direct all correspondence to: Eduvigis Cruz-Arrieta, PhD, Stephen D. Hassenfeld Children’s Center for Cancer and Blood Disorders, 160 E 32nd St, Second Floor, New York, NY 10016; Tel: 212-263-9925; Fax: 212-263-8410; E-mail: Eduvigis.cruz-arrieta@nyumc.org.

 


 

 

Abstract

The use of behavioral techniques such as shaping and differential attention used to teach children ≥18 months of age how to swallow pills is well documented. However, there is a lack of data on the capacity of children of various ages to ingest pills. Pediatric cancer patients as young as 3 years of age must learn to take pills in order to benefit from alternative treatments for their conditions due to difficulties in drinking liquid formulations or requiring medication only available in pill form. Parents are trained on how to hide medication in foods, but they are not coached on how to teach their children to take pills. The stress of pediatric cancer and its effect on caregivers makes this a priority. This article provides guidelines on how to do this.

 

Introduction

The use of well-known behavioral techniques such as shaping and differential attention used to teach children ≥18 months of age how to swallow pills has been documented extensively.1-7 There is a lack of data on the capacity of children of various ages to ingest pills. One recent study showed that the majority of children 6–11 years of age say they can successfully swallow small tablets.8 The majority of the literature has further developed from the research and treatment of young pediatric AIDS patients who needed help learning how to take several pills per day indefinitely as part of the long-term management of HIV. At the Stephen D. Hassenfeld Children’s Center for Cancer and Blood Disorders of New York University Langone Medical Center, the need for patients as young as 3 years of age to learn how to take pills in order to benefit from alternative treatments for their conditions was identified. Some children were rejecting liquid formulations due to its bitter taste. This prompted both medical staff members and parents to seek other ways to provide the medicine. Other children required medication only available in pill form. Although parents can be advised to hide medication in palatable foods, some are uncomfortable with this strategy, especially if their child notices this. Most deny it to the child and report feeling “bad” for “tricking” him or her. As children are perceptive, they sense when “something is up” as one parent described it. This sometimes increases the child’s resistance to participating in other medical procedures. Given the stressful nature of pediatric cancer and its effect on caregivers, finding less stressful alternatives to caring for their children is always a priority.

 

Treatment Goals and Method

The treatment goals include increasing children’s self-efficacy in one aspect of their treatment by applying something they already know how to do (eg, “swallowing”) to their medical regimen at will, shortening the time spent taking medication by introducing a simple, fast way of ingesting it, reducing the need for coercive methods for administering medication by teaching parents how to present medication to their children, and providing age-appropriate psycho-education on why, when, and how children take medicine. This article reviews the author and colleagues’ experience teaching this skill to pediatric cancer patients. It illustrates modifications necessary when working with pre-schoolers with cancer in acute need to begin oral chemotherapy through case examples. Additional emphasis on role modeling and attention to cultural sensitivity as it applies to the interaction between patients and therapists of different ethnic and cultural backgrounds will be noted.

Various research studies document the use of candy and chunks of ice3,7 for this training. Cruz-Arrieta and colleagues believe that a method that distinguishes between eating candy and taking medicines aligns with the goal of sending a cohesive message about best practices to parents, despite anecdotal reports about successful use of candy (eg, “Tic Tac” mints, mini M&Ms, jelly beans) for this purpose in non-clinical settings.

The authors adopted the pill training protocol designed by Czyzewski from the Texas Children’s Hospital (D. Czyzewski, personal communication, June 2007). This spells out the presentation of placebos of increasing size, after demonstrating proper posture and pill swallowing technique, while providing no further attention to protests or distractions. Czyzewski and colleagues10 have produced two training videos designed to demonstrate proper training techniques as well as suggestions for common problems during and after the training.12,13 Modeling their tools after this material, the authors organized pill boxes using sugar-free, odorless, flavorless, gluten-free, and kosher placebos that ranged in size from size 4 (38–44 mg) to 00 (93–105 mg). None of the medications currently administered to the patients exceed a size 2 (57–65 mg). Regardless, the trainers practiced taking all placebo sizes to be able to compare and answer such questions from parents. In addition, the psychologist/trainer selected what to say beforehand and practiced a basic script to become comfortable with the information provided to the parents and their children during the session.

Six children (four boys and two girls) 3–5 years of age were referred by either the nurse practitioners and physicians working with the families or by the parents themselves. Five of these patients had brain tumor diagnoses and one had leukemia. As all of the children were from a different cultural and racial background than the trainer, questions relevant to the children’s family background were answered to accommodate parental requests when appropriate (eg, “my son cannot eat anything that is not kosher”). For example, a staff recreational therapist was asked to join the training session with the psychologist to increase the level of comfort for a boy 5 years of age with vision problems who responds very well in the presence of the recreational therapist but withdraws from unfamiliar people. The recreational therapist took turns taking placebo, modeling the behavior for the child. Another patient required that the psychologist discuss commonly used parenting strategies in the mother’s country of origin (eg, instructing the child to do something in a stern tone of voice to command respect) versus mainstream American practices (eg, instructing the child in a neutral tone) pertinent to handling the child’s potential medication refusal.

The psychologist met with each child’s parents before beginning the child’s training to review the plan and discuss how they can supplement their child’s learning of the skill using positive behavioral techniques. For example, they were instructed to reinforce approximations of successful pill swallowing while withdrawing attention for avoidance, whining, gagging, and vomiting behaviors.14 The psychologist encouraged parents to model pill-taking behavior at home as part of their morning routine by taking their multivitamins or any other medication within view of their child. Emphasis on keeping this as low key as possible was made. A tip sheet based on Czyzewski’s instructions (D Czyzewski, personal communication, June 2007) given to the parents at the end of the consultation is shown in the Table.

 

In general, all parents voiced disbelief about children’s ability to swallow pills and their child’s ability in particular. Parents with stronger opinions mentioned their “child is too young,” the pills are too big,” or the child “is stubborn.” These parents experienced more difficulties in maintaining their child’s newly acquired behavior at home.

 

Case 1: K.S.

At 5 years of age, K.S., a brain tumor patient, had a history of medication refusal and difficulties with medical procedures such as intravenous placements. Coercion was used to make him drink liquid medication at least once prior to referral for pill-swallowing training. The child required structured play time (ie, listening to a story about children with illness) in the psychology office before he was able to separate from his mother for the training. Despite a brief episode of gagging and some regurgitation, he learned to swallow pills on his first visit. Following two successful courses of oral medication that required five pills in a row over a 3-week period, K.S. reverted to his medication refusal behaviors. He attended a second training session after which he regained his skill. However, his parents remained anxious about his ability to do this at home, and shortly after he began to refuse again. Additional parental consultations were offered during a time off from treatment to assist them with resuming their giving pills to the patient.

K.S.’s statements concerning his not having to take pills (“I do not have to do this”) followed by his refusing all parental attempts to convince him to accept his pills were the most striking features of the interaction. He convinced his parents of their inability to make him do what he did “not have to.” The work continues as of the time of writing this report.

 

Case 2: S.D.

The parents of S.D., a 5-year-old boy, also expressed doubts about his ability to learn pill taking given his tendency to get “nervous easily.” Upon meeting S.D., it was evident that he tended to talk himself into feeling “scared,” as he repeatedly mentioned this to the psychologist on the way to the office. On his third visit, he was able to take three placebos and shared his newly learned skill with his father. He began his oral chemotherapy pills the next day and did not have any difficulties with his medication schedule for 6 months.

 

Case 3: S.N.

S.N., another 5-year-old brain tumor patient, was referred by her neuro-oncologist. She was identified as having some developmental delays. Her family needed additional guidance regarding the training, as she was perceived as “too young” for it. She was easily engaged by the psychologist; she separated easily from her mother and completed the training faster than anticipated (ie, 5 minutes into the presentation of the task). S.N. quickly demonstrated it for her mother who had originally been skeptical of her child’s achievement due to the ease in which the girl mastered the task. A follow-up after 6 months since training indicated no relapses in her ability and willingness to take pills.

 

Case 4: C.A.

C.A., a 9-year-old boy, was seen after completing a second round of treatment, post-relapse, for a brain tumor. He successfully learned to take pills under a psychologist’s supervision using Tic-Tacs but was not able to resume taking any medication in pill form due to intense gagging each time he tried. In addition, C.A. had a history of being extremely controlling of his environment as well as showing signs of hyperactivity and inattentiveness. C.A. refused to cooperate, citing increased anxiety at the thought of engaging in pill taking. Additional anxiety-reducing techniques that he previously learned to assist him during magnetic response imaging scans and radiation therapy were offered without success. He complained about wanting to be “retrained” with candy. The training was canceled after one session rather than risking an increase of his refusal behaviors that could prevent future training. Family issues and changes in the family structure took precedence over pill taking training, particularly since C.A. had finished treatment and was now on long-term follow-up.

 

Case 5: E.L.

E.L. is a very bright girl who was 32 months old at the time of her training. Her parents expressed multiple questions regarding her age, the size of her throat (she is petite for her age), the protocol, how to implement the pill-taking schedule at home, and what to do if she did not learn. They were somewhat surprised and reassured after she successfully swallowed a size-2 placebo in two brief visits. After this, the parents wanted to “practice” at home with more placebos. Concerns about practice failure with overanxious parents led to the psychologist discouraging the parents, beyond the general guidelines listed in the learning tip sheet, from doing any practice in the home. They succeeded in presenting the medication to their daughter on the first night of treatment. E.L. took the medication as prescribed. On the second day, she gagged after tasting the bitterness of the medication, as it dissolved in her mouth. Parents’ efforts were not successful and E.L. resumed taking the rest of the doses in liquid form. E.L. informed the psychologist that she will try this again when she turns “four.”

 

Case 6: O.B.

O.B., a 5-year-old leukemia patient, was referred for training soon after his diagnosis. The family provided a history of learning problems, parenting issues, and anxiety. However, only anxiety was mildly evident in O.B.’s overt behavior. These were considered factors working against maintaining his anxiety low and keeping motivation high enough to learn and practice pill taking on a regular basis. O.B. participated in the training after some initial difficulty separating from his mother to do so. His parents succeeded at having O.B. take pills 2 nights in a row, followed by refusal and vomiting as well as another parent training session in person (without the patient present) to review basic troubleshooting strategies for home and offer additional support to decrease parental anxiety over the procedure. Two weeks later, O.B. spontaneously reported mastering his new skill when greeted by the trainer in the clinic’s hallway. Three months later, he still takes pills successfully and uses empty placebo caps to consolidate several smaller tablets into one dose.

 

Discussion

The examples briefly described here emphasize the importance of proper parental preparation for pill-taking training prior to attempting to teach the child. While maintaining a “matter-of-fact” attitude about medical procedures; offering brief, age-appropriate explanations for why their kids need to take medicine; modeling the behavior for their child without pressure to perform; and keeping their own nervousness in check, parents of young children with cancer can better incorporate pills into their children’s treatment. However, even after a successful training, children may dislike the taste of some medications. This may be addressed by using strategies such as placing a bitter tablet inside a flavorless capsule to help maintain the newly acquired skills of these children. The literature points to a combination of skill deficit, anxiety, and lack of motivation as factors related to pill swallowing difficulties. The author and colleagues’ experience with the cases briefly presented here showed that when training was not successful, this could be partially explained by pre-existing risk factors associated with poor success rates. These include a history of negative experiences associated with pill taking such as coercion; oppositional or controlling tendencies; anxiety; strong food preferences (eg, “picky eaters”); or a perception of a sense of urgency and desirability of quick learning to the child coming from parents and staff. The importance of a comprehensive pre-training interview with parents and medical staff as a strategy to plan how to teach the skills best while reducing anxieties and increasing motivation in both the child and the parents cannot be stressed enough.

 

Conclusion

There is a need to further study the usefulness of teaching pill-swallowing skills to both parents and medical staff as well as training children with cancer. A formal clinical trial evaluating the success of this approach in the pediatric oncology setting is needed in order to provide a more comprehensive way of determining success rates using this approach.

Providing psycho-education to parents and medical staff on pill swallowing training principles and techniques ensures that all adults communicate a consistent message to the child (“you can do it,” “this is easy,” and “we are here to teach you how”). Their children will become confident and competent participants in their own medical treatment if given the proper tools. PP

 

References

1.    Babbitt RL, Parrish JM, Brierley PE, Kohr MA. Teaching developmentally disabled children with chronic illness to swallow prescribed capsules. J Dev Behav Pediatr. 1991;12(4):229-235.
2.    Pelco LE, Kissel RC, Parrish JM, Miltenberger RG. Behavioral management of oral medication administration difficulties among children: a review of literature with case illustrations. J Dev Behav Pediatr. 1987;8(2):90-96.
3.    Walco GA. A behavioral treatment for difficulty in swallowing pills. J Behav Ther Exp Psychiatry. 1986;17(2):127-128.
4.    Funk MJ, Mullins LL, Olson RA. Teaching children to swallow pills: a case study. Child Health Care. 1984;13:20-23.
5.    Dahlquist LM, Blount RL. Teaching a six-year-old girl to swallow pills. J Behav Ther Exp Psychiatry. 1984;15(2):171-173.
6.    Sallows GO. Behavioral treatment of swallowing difficulty. J Behav Ther Exp Psychiatry. 1980;11:45-47.
7.    Wright L, Woodcock JM, Scott R. Conditioning children when refusal of oral medication is life threatening. Pediatrics. 1969;44(6):969-972.
8.    Meltzer EO, Welch MJ, Ostrom NK. Pill swallowing ability and training in children 6 to 11 years of age. Clin Pediatr (Phila). 2006;45(8):725-733.
9.    Garvie PA, Lensing S, Rai SN. Efficacy of a pill-swallowing training intervention to improve antiretroviral medication adherence in pediatric patients with HIV/AIDS. Pediatrics. 2007;119(4):893-899.
10.    Czyzewski DI, Runyan RD, Lopez MA, Calles NR. Teaching and maintaining pill-swallowing in HIV-infected children. AIDS Reader. 2000;10(2):88-95.
11.    Czyzewski D. Teaching Pill Swallowing [videotape]. Houston, TX: Texas Children’s Hospital & Genentech; 2004.
12.     Baylor International Pediatric AIDS Initiative. Teaching and Reinforcing Essential Skills for Taking Important Medications [videotape]. Houston, TX: Baylor College of Medicine; 1998.
13.    LaGrone RG. Hypnobehavioral therapy to reduce gag and emesis with a 10-year-old pill swallower. Am J Clin Hypn. 1993;36(2):132-136.

 

Dr. Kennedy is professor in the Department of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine, and director of the Division of Geriatric Psychiatry at Montefiore Medical Center in the Bronx, New York.

Disclosure: Dr. Kennedy has received research support or honoraria from AstraZeneca, Eli Lilly, Forest, Janssen, Myriad, and Pfizer.

Please direct all correspondence to: Gary J. Kennedy, MD, Director, Department of Geriatric Psychiatry, MMC, 111 East 210th St, Klau One, Bronx, NY 10467; Tel: 718-920-4236; Fax: 718-920-6538; E-mail: gjkennedy@msn.com.

 


 

The evidence base supporting the treatment of psychotic depression among older adults is scant. Although the consensus regarding the best therapeutic opinion favors electroconvulsive therapy, most patients, their families, and practitioners will exhaust medication alternatives first. Recent preliminary reports from the Study of the Pharmacotherapy of Psychotic Depression  (STOP-PD) suggest a 12-week program of combined antidepressant and antipsychotic pharmacotherapy may achieve remission rates as high as 60%.

The recognition of psychotic depression, more appropriately described as delusional depression, has particular relevance to primary care physicians. Patients with psychotic depression have sustained irrational beliefs (delusions) associated with depressed mood that are often plausible. Psychotic depression should be suspected when the irrational belief focuses on somatic symptoms or around fears of a serious physical condition when there is no medical evidence identified to support the belief despite adequate examinations. Patients with somatic delusions visit multiple specialists and obtain repeated testing to identify problems they “know” exist rather than for the purpose of seeking relief from persistent somatic “worries.” The careful assessment of depressed patients to determine whether their concerns are plausible would presumably reduce the 25% rate at which the presence of delusions associated with major depressive disorder (MDD) is not recognized.1

However, due to the obsessional yet plausible quality of the delusion, obsessive-compulsive disorder (OCD) may be a reasonable possibility. The difference between obsessive rumination and delusional thinking can be difficult to distinguish.2 Body dysmorphic disorder (BDD) with psychosis, which is characterized by an irrational belief that one’s physique is seriously flawed despite obvious evidence to the contrary, may also complicate the diagnostic consideration. Hypochondriasis is a common feature of delusional depression misdirecting the diagnostician to a somatoform rather than a mood disorder. The distinction is important because BDD responds to monotherapy with a selective serotonin reuptake inhibitor.3 Difficulty concentrating, deficits in executive function, and subjective complaints of impaired cognition suggestive of dementia are frequently seen. The occurrence of depression with hallucinations but not delusions in older adults suggests structural brain diseases, bipolar disorder, or schizoaffective disorder. In addition, other symptoms of MDD may not be so prominent or severe, further distracting the practitioner from the correct diagnosis. Differentiating schizoaffective disorder from psychotic depression may also be difficult because the distinguishing the sequence of symptom emergence, which is the presence of psychosis prior to depression, is unreliable.4  

When psychosis complicates MDD the evidence directing choice of pharmacotherapy for older adults is scant but emerging. Mulsant and colleagues5 randomized 52 patients with a mean age of 72 experiencing a major depressive episode with psychotic features to nortriptyline plus perphenazine or nortriptyline plus placebo. All were openly treated with nortriptyline initially with the dose titrated to between 50–150 ng/mL (target=100 ng/mL). For patients not responding within 2 weeks, placebo (n=19) or perphenazile (n=17) in randomized double-blind protocol were then administered. The placebo or perphenazine doses were then titrated to a maximum dose of 24 mg/day until either a therapeutic response or extrapyramidal side effects occurred. The mean dose of perphenazine was 18.9 mg/day. At a mean duration of 9 weeks for combined therapy, only 50% of people receiving nortriptyline plus perphenazine and 44% receiving nortriptyline plus placebo achieved a categorical response. Similarly, there were no statistically significant differences between the two groups’ depression severity as measured by the Hamilton Rating Scale for Depression (HAM-D) or the psychoticism subscale of the Brief Psychiatric Inventory. Although the response rate among those with a Mini-Mental State Examination (MINI) score of ≥27 was twice that of those with a score below, the difference was not significant. Of the 36 patients randomized, only five achieved the target dose of perphenazine while only 30 completed the protocol.

Mulsant and colleagues5 concluded that the mediocre response rates did not favorably weigh against the potential toxicity of a tricyclic antidepressant combined with typical antipsychotic. They also speculated that the brief period of treatment and insipient dementia might account for the poor results. They concluded that newer agents either singly or in combination might be used but that electroconvulsive therapy (ECT) should be offered promptly if the patient failed to respond. ECT is effective for depression complicated by psychosis.6 It is often considered the treatment of choice due to poor response rates or adverse events associated with monotherapy or combined therapy with an antidepressant and antipsychotic.7 Yet, few patients or their family members will consider ECT without having exhausted alternatives. The need for reliable predictors of successful pharmacotherapy is thus critical for patients, their families, and their physicians.

The multi-site STOP-PD was designed to have sufficient participants with an extended age range to address numerous limitations of prior studies.7 To approach diagnostic precision, the investigators excluded people with OCD, BDD, and dementia, even if they met criteria for psychotic depression, as well as those with schizoaffective disorder (psychosis over a 2-week period free of depression). Participants were stratified by age such that the number of patients 18–59 years of age equaled the number of patients ≥60 years of age, in order to examine the effect of age on treatment responsiveness as well as tolerance. Executive cognitive dysfunction was to be measured with the Initiation Perseveration subtest of the Mattis Dementia Rating Scale and the Stoop Color Word Test. The MINI was used as a global measure of cognitive impairment associated with depression rather than as an exclusion criterion for suspected dementia. The hypothesis to be tested was the relationship between global impairment generally and executive dysfunction specifically as a predictor of poor response to treatment. 

A 12-week acute phase of treatment was to be followed by a 12-week stabilization phase extending the period of treatment considerably longer than prior studies. In the acute phase, participants were randomized to olanzapine plus placebo or sertraline plus olanzapine. Outcome measures for the acute phase included non-remission, partial remission, and full remission. Partial remission required a 30% reduction to a threshold score no higher than 17 from the baseline HAM-D. Full remission was defined by a score of <10 on the HAM-D. Both remission categories required an absence of hallucinations and delusions. For the subsequent 12 weeks of the stabilization phase, partial responders who had received sertraline plus olanzapine were randomized to augmentation with lithium or placebo. Partial responders who had initially been given placebo plus olanzapine received augmentation with sertraline plus placebo lithium. This allowed for a comparison of the benefits of adding lithium when a partial remission occurred for people previously treated with combined sertraline plus olanzapine compared to the addition of sertraline for those treated previously with olanzapine only.

The dosing protocol started with sertraline 50 mg each morning and/or olanzapine 5 mg each evening. Doses were escalated every 3–7 days up to 15 mg olanzapine and/or 150 mg sertraline depending on response and tolerability. If after 2 weeks the patient remained symptomatic, sertraline could be increased to 200 mg and olanzapine to 20 mg. When doses were reduced due to intolerance and the patients remained symptomatic, they were re-challenged with the higher dose at a later date. Remission was achieved in 40% of all patients randomized and 67% of those completing the study who received a combination of sertraline and olanzapine over 12 weeks. The average age of participants was 72 years but remission rates were comparable for those above and below 60 years of age. Remission rates with combination therapy were substantially and significantly better than with sertraline alone. The average end-of-study daily doses of were approximately 150 mg of sertraline and >12 mg of olanzapine.9 Weight gain was a frequent side effect and more prevalent among the younger participants. The effects of any physical illness and cognitive impairment have yet to be determined. In addition, the benefits, if any, of augmenting therapy with lithium have yet to be reported.  More importantly, the profile of people least likely to respond or to tolerate this course of pharmacotherapy and who should be offered ECT early rather than later remains to be determined.

A 90-day treatment period for patients given a combination of sertraline and olanzapine offered substantially better prognosis than previously observed. Therefore, while ECT remains an effective treatment option for late-life psychotic depression, intensive combination of antipsychotic and antidepressant pharmacotherapy may be an effective initial strategy. PP

 

References

1. Andreescu C, Mulsant BH, Peasley-Miklus C, et al. Persisting low use of antipsychotics in the treatment of major depressive disorder with psychotic features. J Clin Psychiatry. 2007;68(2):194-200.
2. DeBattista C, Lembke A. Challenges in differentiating and diagnosing psychotic depression: phenomenology and the pursuit of optimal treatment. Primary Psychiatry. 2008;15(4):59-64.
3. Phillips KA. Psychosis in body dysmorphic disorder. J Psychiatr Res. 2004;38(1):63-72.
4. Rothschild AJ, Mulsant BH, Meyers BS, Flint AJ. Challenges in differentiating and diagnosing psychotic depression. Psychiatric Ann. 2006;36(1):40-46.
5. Mulsant BH, Sweet RA, Rosen J, et al. A double-blind, randomized comparison of nortriptyline plus perphenazine versus nortriptyline plus placebo in the treatment of psychotic depression. J Clin Psychiatry. 2001;62(8):597-604.
6. Practice guideline for treatment of patients with major depressive disorder (revision). American Psychiatric Association. Am J Psychiatry. 2000;157(4 suppl):1-45.
7. Meyers BS, Klimstra SA, Gabriele M, et al. Continuation treatment of delusional depression in older adults. Am J Psychiatry. 2001;9(4):415-422.
8. Meyers BS, Peasly-Miklus C, Flint AJ, Mulsant BH, Rothschild AJ. Methodological issues in designing a randomized controlled trial for psychotic depression: the STOP-PD study. Psychiatric Ann. 2006;36(1):57-64.
9. Meyers BS, Peasly-Miklus C, Flint AJ, Mulsant BH, Rothschild AJ, Whyte E. Efficacy and tolerability of pharmacotherapy for psychotic depression: age effects. Paper presented at: the Annual Scientific Meeting of the American Association for Geriatric Psychiatry; March 15, 2008; Miami, FL.

 

Dr. Erman is clinical professor in the Department of Psychiatry at the University of California, San Diego School of Medicine, a staff scientist for the Scripps Research Institute Department of Neuropharmacology, and chief medical officer of Avastra USA.

Disclosures: Dr. Erman is a consultant to Cephalon, Mallinckrodt, Neurocrine, sanofi-aventis, and Takeda; is on the speaker’s bureaus of Forest, sanofi-aventis, and Takeda; is on the advisory boards of Cephalon, Neurocrine, sanofi-aventis, and Takeda; has received grant/research support from Arena, Cephalon, Eli Lilly, GlaxoSmithKline, Mallinckrodt, Merck, Organon, Pfizer, Pharmacia, ResMed, sanofi-aventis, Schwarz Pharma, and Takeda; and owns stock in Cephalon, Forest, Merck, Neurocrine, Pfizer, sanofi-aventis, and Sepracor.

 


 

From ghoulies and ghosties
And long-leggedy beasties
And things that go bump in the night,
Good Lord, deliver us!
       –Traditional Scottish Prayer

 

70-year-old female patient is screaming out at night. This has been going on for several decades but has been getting worse lately and is disturbing her husband’s sleep. She also has Parkinson’s disease, but this has only been present for approximately 10 years. Is this a sleep disorder? What stage of sleep is it likely occurring from?

Ancient history denotes the nighttime hours as a period of risk and uncertainty. It was believed that the soul left the body during people’s usual nightly episodes of sleep, and prayers for the safe return of the soul are common in numerous cultures. Abnormal behaviors occurring as one came out of sleep were also appreciated yet feared and misunderstood. Common knowledge “recognized” that a sleep walker should not be awakened for fear that he or she will die or be harmed; in more extreme forms of behavior, it was assumed that demonic possession was the cause of disturbed dreams or abnormal behaviors.

Most parasomnias, which are disorders associated with the occurrence of sleep but not necessarily disruptive of sleep itself, present in childhood and are seen with decreasing frequency as people age. Examples of such phenomena are enuresis (ie, bed-wetting), nightmares (ie, “rapid eye movement [REM] anxiety dreams”), sleep walking, sleep talking, and sleep terrors (ie, “night terrors”). A hereditary basis has been demonstrated for most of these disorders, and a strong family history is usually reported when parents or other family members are questioned.

Stress may be a contributing factor to the presentation of parasomnias or may increase their severity, but most of these disorders are not suggestive of the presence of any mental disease or condition. Patients with nightmares may at times be an exception to this statement. Particularly in adult life, the presence of anxious dreams, especially those with recurrent, violent content, may be associated with anxiety disorders or conditions such as posttraumatic stress disorder.

Most frequently, sleep deprivation, which may increase the intensity of deep non-dreaming (delta) sleep, is a factor when such problems present in adolescence or adult life.

First described in 1986, REM sleep behavior disorder (RBD), like sleepwalking, is associated with complicated behaviors during sleep such as walking, running, singing, and talking.1 In contrast to sleepwalking, which occurs during the first third of the night during delta sleep, RBD usually occurs during the second half of the night during REM sleep.

In order to appreciate the pathophysiology of RBD, it is critical to understand the basic physiology of REM (dreaming) sleep. In REM sleep, the skeletal muscles associated with voluntary movements are paralyzed. This paralysis (ie, atonia) is seen in association with REM sleep in all mammalian species that have been studied and appears to be an integral component of dream sleep.

Why should this paralysis of the voluntary musculature be a “desirable” or necessary component of REM? To the dreamer, the world experienced in the dream is reality. If, in one’s dream, he or she is walking down the street, the voluntary muscles would receive innervation that would accomplish this task. Such activity would be disruptive of the capacity to maintain continuity of dreaming sleep and could be dangerous to the “enacted” dreamer as well.

Prior to the initial description of RBD, animal research demonstrated that the normal atonia of REM sleep could be disrupted as a consequence of specific brain lesions. In 1965, Jouvet and colleagues,2 in France, performed bilateral lesions in the midbrain (ie, “pons”) of cats, blocking the normal inhibition of muscle tone seen in REM sleep. These animals showed prominent, and apparently purposeful, motor behavior in REM sleep. Although it is impossible to know with any certainty what, if anything, the cats were dreaming, the behaviors seen included apparent predation (eg, act of trapping a mouse or other prey with a paw or swiping at and pouncing on an unseen object.)

 RBD, the human version of that disorder, apparently occurs as a consequence of loss of the muscle atonia that is normally present during REM sleep (although intermittent throughout the night), facilitating enacted dream motor activity. The intensity of motor activity may vary and usually increases in severity with passage of time and progression of the disease. Initial manifestations may be of sleep talking or mumbling, often associated with small motor activity. The movement activity that occurs often appears purposeful or semi-purposeful. Direct examples include patients appearing to be scolding someone and shaking their finger at them; cutting food with a fork and knife and moving it to their mouth to eat; folding objects (eg, clothes); and engaging in sports (eg, fly-fishing). Verbal outbursts may sound angry and include vulgarity or obscenities never uttered by these quiet individuals during their waking hours.

In contrast to history typically obtained from patients with sleepwalking or other non-REM arousal disorders, memory for dream content is usually good in patients with RBD when they are questioned after arousal from an RBD episode. They are usually able to describe what was occurring in their dream and what they were attempting to accomplish, which led to their enacted dream activity. Even when dream content is neutral or pleasant, patients or their bed partners may be at risk of injury as a result of this motor activity occurring out of REM sleep. For example, patients have injured themselves by throwing themselves out of bed in association with dreams of sports activities, including chasing a long fly ball and running down field to catch a pass in football.

Patients with RBD frequently experience frightening or threatening dream content that may provoke a “defensive” response on their part, putting bed-partners at risk. For example, if a patient is fighting a wild animal, assailant, or someone trying to steal his or her car or kidnap a family member in a dream, the individual may be choking, punching, or otherwise assaulting his or her spouse or bed partner in reality.

In contrast to non-REM parasomnias that usually present in childhood, RBD typically occurs in men during the sixth or seventh decade of life. The cause or causes remain unknown. The current understanding of this disorder’s etiology is that it is usually idiopathic, though it may be seen in association with neurodegenerative disorders (ie, Parkinson’s disease, olivopontocerebellar degeneration, Shy-Drager syndrome, dementia with Lewy body disease).3 RBD is often the first manifestation of these conditions, and it may precede any other neurologic symptoms by >10 years.4

Although a clear long-term causal relationship has not been established, apparent medication-induced loss of REM atonia has been observed in patients receiving tricyclic antidepressants5 and selective serotonin reuptake inhibitors.6

Diagnosis of RBD is often delayed for years or decades, as physicians assessing the patient may be unaware of the existence of the disorder. The diagnosis may be suspected on clinical grounds, especially when “atypical” nocturnal behavior, including vocalization, semi-purposeful motor activities, or apparent assaults of a bed partner, occurs in individuals with no apparent behavioral or emotional difficulties seen during the daytime. When possible, the diagnosis should be confirmed by polysomnographic (PSG) evaluation. In addition to the intermittent absence of atonia, PSG findings include bursts of increased muscle tone seen on EMG and limb twitching (usually far greater than what is seen in normal REM sleep) and complex, at times violent, behavior associated with reported dream imagery. PSG also allows the opportunity to rule out the co-existence of other sleep disorders that could provoke episodes of RBD, such as sleep apnea, and to ensure that the behavior seen is not an epileptiform disorder.
Treatment of RBD usually includes nocturnal administration of clonazepam, typically in a dose of 0.5–1.5 mg, though some patients require doses of up to 3–4 mg for effective treatment. Treatment with clonazepam is often remarkably successful in controlling the symptoms of this disorder, although the mode of therapeutic effect of the agent is not known.

Antidepressants may have the capacity to provoke or exacerbate the severity of RBD. When patients are taking these medications, efforts should be made to reduce the dose of or eventually discontinue treatment when possible.

Limited studies, typically performing open-label trials in small case series, suggest that melatonin in doses of 3–12 mg at night may be effective for some patients who have not responded to treatment with clonazepam.7 PP

 

References

1. Schenck CH, Bundlie SR, Ettinger MG, Mahowald MW. Chronic behavioral disorders of human REM sleep: a new category of parasomnia. Sleep. 1986;9(2):293-308.
2. Dusan-Peyrethon D, Peyrethon J, Jouvet M. Quantitative study of phasic phenomena of paradoxal sleep during and after its instrumental deprivation [French]. C R Seances Soc Biol Fil. 1967;161(12):2530-2533
3. Boeve BF, Silber MH, Ferman TJ, Lucas JA, Parisi JE. Association of REM sleep behavior disorder and neurodegenerative disease may reflect an underlying synucleinopathy. Mov Disord. 2001;16(4):622-630.
4. Schenck CH, Mahowald MW. Rapid eye movement sleep parasomnias. Neurol Clin. 2005;23(4):1107-1126.
5. Shimizu T, Ookawa M, Iijuma S, et al. Effect of clomipramine on nocturnal sleep of normal human subjects. Annu Rev Pharmacopsychiat Res Found. 1985;16:138.
6. Schenck CH, Mahowald MW, Kim SW, O’Connor KA, Hurwitz TD. Prominent eye movements during NREM sleep and REM sleep behavior disorder associated with fluoxetine treatment of depression and obsessive-compulsive disorder. Sleep. 1992;15(3): 226-235.
7. Takeuchi N, Uchimura N, Hashizume Y, et al. Melatonin therapy for REM sleep behavior disorder. Psychiatry Clin Neurosci. 2001;55(3):267-269.

Psychiatric Dispatches

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Primary Psychiatry. 2008;15(7):24-26

FDA Approves Duloxetine HCI for the Management of Fibromyalgia

The United States Food and Drug Administration approved duloxetine HCI (Cymbalta, Eli Lilly) for the management of fibromyalgia. Fibromyalgia is estimated to affect 2% of the United States population, with the majority of diagnoses being made in women.

Approval was based on the results of two 3-month clinical trials representing 874 patients with fibromyalgia. In week 1 of both studies, the duloxetine group demonstrated significant improvement in pain compared to placebo, according to the Brief Pain Inventory (BPI), a 24-hour average pain scale. Fifty-one percent and 55% of patients on duloxetine of the two respective studies experienced a 30% improvement (the threshold for clinical pain improvement) on the BPI by endpoint. Also, at both trials’ endpoint, 65% and 66% of patients on duloxetine 60 mg/day reported overall symptomatic improvement according to the Patient Global Impression of Improvement scores.

The most common adverse events associated with duloxetine include nausea, dry mouth, constipation, decreased appetite, sleepiness, increased sweating, and agitation.

For more information, please consult the medication’s full  prescribing information. (www.insidecymbalta.com). —LS

 

Acute Stress Disorder and PTSD Diagnoses May Predict Future Onset of Chronic PTSD

Survival after a major burn injury has substantially improved over the past 20 years. However, there is evidence of psychological distress and disorders following this type of injury, including acute stress disorder (ASD) and posttraumatic stress disorder (PTSD). A study by Jodi B. A. McKibben, PhD, and colleagues, considered whether an ASD diagnosis, with its dissociative symptoms, is a better predictor of chronic PTSD than a PTSD diagnosis made at the same time in a major burn population.

The study involved 178 hospitalized adult patients (73.6% male; 23.4% female) with major burns treated at Johns Hopkins Burn Center. Scores from self-report measures, including the Stanford Acute Stress Reaction Questionnaire (SASRQ), Davidson Trauma Scale (DTS), and Brief Symptom Inventory, were used to determine biopsychosocial function at five time periods. In accordance with criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the SASRQ assessed ASD and PTSD at discharge from the center (n=178) while the DTS assessed PTSD at 1 (n=151), 6 (n=111), 12 (n=105), and 24 (n=71) months after discharge. Results found that both ASD and PTSD diagnoses at discharge were major indicators of future onset of PTSD at 1, 6, and 12 months, but not at 24 months, with no significant differences in predictive ability at any time. 

McKibben and colleagues suggest future research to measure all ASD and PTSD criteria at discharge, as the current study neglected to assess two PTSD avoidance criteria (ie, decreased interested/participation and sense of limited future). In addition, structured interviews assessing ASD and PTSD as well as efforts to reduce attrition rates in burn populations from other hospitals would further validate and address the generalizability of results. (APA 2008; Poster NR 6-069). –ML

 

Parents With Bipolar Disorder at Increased Risk for Substance Use Disorders Than Healthy Parents

According to the National Institute of Mental Health, bipolar disorder is often comorbid with substance use disorders, which may be caused by bipolar mood symptoms often exacerbated by alcohol and drug use, a patient’s intent to self-medicate symptoms, and other risk factors related to both bipolar disorder and substance abuse. Research has shown that substance use disorder risk is increased among parents of youths with bipolar disorder, particularly if parents also have bipolar disorder.

However, there have been few studies that investigate the prevalence of substance use disorders among parents with bipolar disorder, separate from the mental health status of the child. The prevalence of substance use disorders may be useful for clinicians, as parental substance use has been shown to increase the risk of child maltreatment and impairment.

Benjamin I. Goldstein, MD, PhD, of the Western Psychiatric Institute and Clinic at the University of Pittsburgh School of Medicine in Pennsylvania, and colleagues, evaluated 448 adult parents with and without bipolar disorder to determine rates of substance use disorder prevalence. Patients were divided by bipolar disorder symptomology (n=274: Type I, n=175; Type II, n=83; not otherwise specified, n=16) or presence of other psychiatric conditions (n=112), and were compared to participants without mental health disorder history (n=62).

Patients were assessed for bipolar disorder via the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID-IV). All children of parents in the study were ≤18 years of age, and 79% of parents were female. Other patient demographic and clinical information regarding substance use was assessed by researchers via interview at the study’s beginning. Demographic variables significantly associated with lifetime prevalence of substance use disorder were included in analysis.

Goldstein and colleagues found that substance use disorders were significantly more prevalent for patients with bipolar disorder (64%) when compared to patients with other psychiatric disorders (40%) or parents without bipolar disorder (21%). This result remained after the authors controlled for between-group differences in socioeconomic and marital status as well as race. When compared to healthy parents with substance use disorders, patients with bipolar disorder showed significantly greater prevalence of alcohol abuse (59% vs. 31%), and cocaine (22% vs. 8%) and opioid (7% vs. 0%) dependence.

In addition, the presence of a substance use disorder in one parent was significantly associated with the development of a substance use disorder in another parent despite bipolar disorder prevalence. Goldstein and colleagues concluded that parents with bipolar disorder are at a greatly increased risk for developing substance use disorders, which may confer genetic and environmental risk of negative outcome for the child.

“It is important for primary care phyisicans (PCPs) who work with families to know that parents with bipolar disorder have increased likelihood of having substance use disorders, and there is also increased likelihood of substance abuse in the other parent. Careful screening for excessive drug or alcohol use is warranted, and PCPs should encourage parents to seek specific treatment for substance abuse ideally in a manner that is integrated with their treatment for bipolar disorder,” Dr. Goldstein said. “Previous studies have found that children of parents who abuse substances are exposed to two-fold increased risk of maltreatment, and the risk is greater when both parents abuse substances. The hope is that early identification of parental substance use disorders and referral for appropriate treatment may decrease this risk to children.”

The authors recommend researchers conduct long-term, prospective studies that examine the potential role of parental substance abuse in relation to mental health and behavioral outcomes for children in the future. Study limitations include the cross-sectional study design and retrospective methodology as well as the lack of a dimensional measure of current substance abuse.

Funding for this research was provided by the National Institute of Mental Health. (APA 2008; Poster NR3-041). –CP

 

Risk Factors and Prevalence of Postpartum Depression

Postpartum depression (PPD) is a form of clinical depression that can affect women after childbirth and can even start toward the end of pregnancy. Often undiagnosed or untreated, the prevalence of PPD is estimated to be 12% to 13%. Risk factors include psychosocial variables such as marital dissatisfaction, inadequate social support, and stressful life events. Demographic variables include adolescent pregnancy, unwanted or unplanned pregnancy, and lower socioeconomic status. Psychiatric family and personal history can also prove to be risk factors as well. Early intervention of PPD is ideal as the disorder can negatively affect both mother and infant.

A study by Nesrin Tomruk, MD, and colleagues, at Bakirköy Research and Training Hospital for Psychiatry, Neurology and Neurosurgery in Istanbul, Turkey, examined postpartum patients in the well-baby unit in up to 9 months postpartum period from July–September 2007 and screened for depressive symptoms using the Edinburgh Postnatal Demographic Depression Scale (EPDS). The cut-off point of the 10-item self-rated questionnaire was ≥13; patients with scores ≥13 were labeled as “high risk for depressive disorder.” Demographic and psychosocial variables as well as reproductive, pregnancy, and delivery data were also collected using a separate 51-item semi-structured form.

According to EPDS scores, PPD was found in 30.6% (n=56) of the 183 mothers in the study (mean age=27.52±5.45). High EPDS scores were also significantly correlated with history of premenstrual syndrome and psychiatric treatment as well as the partner’s unemployment, dissatisfaction in marriage, low level of care of the partner, and domestic violence. Also of statistical significance, high EPDS scores were correlated with unplanned pregnancies, nocturnal delivery, health problems during pregnancy in both the mother and fetus, a “difficult baby,” and not nursing.

The study is limited in that the EPDS, when used alone, is not a diagnostic tool for depression. Depression diagnosis should be verified with clinical evaluation as well as other depression scales. However, the EPDS is useful for screening pregnant and postpartum women for early detection and treatment of PPD. (APA 2008; Poster NR 6-120). –DC

 

HIV Patients with Comorbid Psychiatric Disorders

Previous research has found that patients who are HIV positive (HIV+) have high rates of both substance abuse as well as psychiatric disorders. However, exact prevalence rates have been hard to determine due to patient non-adherence. Rachel A Houchins, MD, and colleagues from the University of South Carolina of Medicine and Palmetto Health Alliance conducted a chart review of 424 HIV+ patients. They collected data regarding age, gender, race, medical conditions, psychiatric diagnoses, substance abuse, income, medications, CD4 count, and viral load of patients seen at the Ryan White Clinic between 2004 and 2006.

Houchins and colleagues found that 41.3% of patients were substance abusers; 35.4% of patients had psychiatric illnesses; 24.9% of patients had a diagnosis of substance abuse; 19% of patients had a psychiatric diagnosis only; and 16.4% of patients had a comorbid diagnosis. However, the rates changed depending on gender and race. They also recorded data regarding patient compliance in terms of medication as well as their ability to keep appointments.

Houchins and colleagues found that a total of 39.7% of patients had no Axis-I diagnosis, 24.9% of all patients had a diagnosis of substance abuse only, 19% had a psychiatric diagnosis only, and 16.4% had comorbidities. When breaking this data down by gender, they found that 72.4% of men were substance abusers only compared to 26.4% of women, while psychiatric diagnosis only was more evenly split (50.6% for men vs 48.2% for women).

When comparing race, 92.5% of blacks were substance abusers only and 70.4% of blacks had a psychiatric diagnosis only Approximately 51% of men had a psychiatric diagnosis only, compared to approximately 48% of women. Comorbidities were more evenly dispersed among gender and ethnicity. They found that 61.4% of men, 38.6% of women, 74.3% of blacks, and 25.7% of whites had comorbidities. Surprisingly, they also found that compliance rates were not statistically different among any of the demographics. In addition, there was no correlation between medical compliance and CD4 counts.

Houchins and colleagues believe that future research should detail the means of engaging the patient in treatment and teach them the means of appropriately participating in their own health care. (APA 2008; Poster NR 1-009).  —CN

 

Threshold Treatment Levels for Functional Improvement in ADHD

Successful long-term outcomes in clinical trials of attention-deficit/hyperactivity disorder (ADHD) treatment have been associated with less severe symptoms at baseline. Conversely, greater symptom severity at baseline can lead to a poorer prognosis. It is less clear, however, to what extent reductions in ADHD symptoms correlate with improved life functioning, as well as what level of treatment is necessary to facilitate functional improvements.

A meta-analysis by Buitelaar and colleagues identified four studies that included a symptomatic measure (ADHD Rating Scale-IV:Parent-Inv [ADHD RS]) and a functional measure (Life Participation Scale [LPS]). The ADHD RS is an 18-item, clinically administered scale that rates the severity of ADHD symptoms with scores ranging from 0–54, with lower scores indicating less symptoms. The LPS, a 24 item scale, measures functional improvements related to treatment with scores from 0–72, with 72 indicating the most improvement.

Subjects, males and females 6–18 years of age at baseline, included those in an atomoxetine group (N=564), methylphenidate (N=220), and placebo (N=256). The mean age of all three groups combined was 10.3 years, and the majority of subjects were diagnosed with ADHD combined type.

Changes in LPS scores over the study’s duration were standardized by calculating the difference between each subject’s change score and the mean of all change LPS scores from all subjects, divided by the standard deviation (SD) of the changes from all subjects. Those with a standardized change of <0.25 SD were defined as indicating no change in functioning, but changes in score >1.0 SD indicated significant functional improvement or worsening. Changes 0.25 SD–1.0 SD indicated a threshold change.

Mean changes in ADHD RS scores were compared with corresponding changes in LPS scores. Buitelaar and colleagues found that a reduction of 16–18 points on the ADHD RS is required for threshold functional improvement, which translates to a 40% to 45% improvement in symptom severity.

A significant improvement in functioning, ie, LPS changes >1.0 SD, requires an ADHD RS score reduction of 20–27 points, which corresponds with 50% to 65% improvement. Overall, an ADHD RS score reduction of at least 20 points is necessary for patients to demonstrate significant improvements in functioning. (APA 2008; Poster NR6-016). –LS

Posters were drawn from the 161st Annual Meeting of the American Psychiatric Association (APA; May 3–8, Washington, DC). Psychiatric dispatches is written by Dena Croog, Michelisa Lanche, Christopher Naccari, Carlos Perkins, Jr, and Lonnie Stoltzfoos.

 

This interview took place on April 29, 2008, and was conducted by Norman Sussman, MD.

 

This interview is also available as an audio PsychCastTM at http://psychcast.mblcommunications.com.

Disclosure: Dr. Allen reports no affiliation with or financial interest in any organization that may pose a conflict of interest.

 

Dr. Allen is both assistant professor in the Department of Psychiatry at the Mount Sinai School of Medicine (MSSM) in New York City and director of psychological services at MSSM’s Center of Excellence in Compulsive and Impulsive Disorders. Her research interests primarily include the treatment of disorders within the obsessive-compulsive spectrum, including obsessive-compulsive disorder and body dysmorphic disorder. In addition, she trains psychiatrists and psychologists on these conditions. Dr. Allen is a widely published author of numerous original research publications and review articles.

 

What are the basic principles upon which cognitive-behavioral therapy (CBT) is based?

CBT refers to a general approach to therapy that includes many different therapies (eg, behavior therapy, cognitive therapy, dialectical behavior therapy, rational emotive therapy) that share the same general philosophy and basic principles. These therapies focus on relieving current symptoms. CBT is an active, directive therapy wherein a therapist acts as a patient’s coach and collaborates with the patient to determine the goals of treatment and the process. The work outside the sessions is an important part of these therapies. There is a big focus on applying what is learned during sessions to the patient’s life. CBT tends to be very evidence based.

One of the most basic assumptions these therapies share is that emotional reactions come from our interpretations of events, not from the events themselves. An ordinary event can seem like a catastrophe to people with obsessive-compulsive disorder (OCD) because of how they are interpreting it. For example, if someone touches a patient with OCD, this action could cause the patient to internally panic. The patient may feel contaminated and be concerned about bringing this contamination home to his or her children, exposing them to serious illnesses. In this example, CBT would focus on identifying, challenging, and modifying the OCD patient’s faulty beliefs and reasoning.

Basic learning principles underlie the behavioral techniques. When they are applied to OCD, the learning principles would predict that the compulsive rituals and avoidance associated with OCD increase a patient’s fears and reinforce his or her obsessions. For example, an OCD patient who repeatedly checks the stove to confirm that it is turned off feels relieved by that checking. According to learning theory, this relief is reinforcing and increases the patient’s need to check. Taking part in these rituals or avoiding uncomfortable circumstances prevents the fear from subsiding; that is, if the person could resist checking the stove, his or her anxiety would end.

 

Is there empirical evidence showing the effectiveness of CBT for the treatment of OCD?

Most studies concerning CBT for OCD focused on the major components of CBT, specifically exposure and response prevention and cognitive therapy. In the studies of exposure and response prevention, the participants are placed in a situation that provokes their OCD and they resist the ritual or the response they feel compelled to perform. Empirical evidence is provided by multiple randomized clinical trials1-4 in which exposure and response prevention outperforms an active treatment control. In general, these trials cannot be double blind as the therapist and patient know which treatment is used. However, there have been trials5,6 comparing exposure and response prevention conducted by a therapist versus by a computer (with the patient also using written self-help materials) that show exposure and response prevention is more effective than placebo or control treatments in reducing OCD symptoms.

The most powerful evidence for the efficacy of exposure and response prevention comes from brain imaging research during the early 1990s. Studies7,8 using positron emission tomography scans prior to and following treatment showed that exposure and response prevention as well as serotonin reuptake inhibitors normalize brain activity.

In terms of the cognitive approach, correcting the patient’s cognitive errors and faulty reasoning is the primary focus. There is evidence from several randomized controlled trials9-12 showing that cognitive approaches are as effective as exposure and response prevention in certain ways and definitely more effective than control treatments. However, the studies showing cognitive therapy to be as effective as exposure and response prevention include behavioral experiments. In these experiments, the patients participate in brief exposures to test the validity of their fears, that is, to see if the feared consequences occur. The major difference between exposure and response prevention and cognitive therapy in these trials is that the exposures were shorter in length in the cognitive therapy conditions. In addition, it is not clear what other kinds of exposures the patients may have faced during the studies, so whether cognitive therapy is effective without exposures is still debatable. At this point, it is unclear that exposure and response prevention is not the central or most powerful curative element in OCD.

Cognitive therapy research indicates that the main drawback to exposure and response prevention is that some patients will avoid such therapy altogether or will drop out of it because they find the very idea of the exposures too scary. I think it is important to consider that perhaps exposures do not need to be as long as we had believed in order to be effective. In reality, most cognitive-behavioral therapists use both exposures and cognitive techniques. Teasing apart the contributions of each might not have that much of an impact on the treatment in the real world.

 

What is relaxation training?

It is a part of CBT that is frequently used, but it is not an effective monotherapy for OCD. However, OCD symptoms are often exacerbated by stress; therefore, relaxation and stress management is part of the treatment. For patients who have a terrible time tolerating anxiety and a phobia of the anxiety itself, decatastrophizing anxiety and helping them learn to be less anxious is imperative.

Relaxation training usually has two elements, ie, deep breathing and muscle relaxation. Deep breathing techniques are taught in sessions and practiced out of session. After patients learn it, they can apply it in stressful situations, possibly reducing the autonomic elements of stress. Progressive muscle relaxation techniques ordinarily include having the patient listen to a 10–30-minute long tape that gets him or her to relax each muscle group, starting with the toes. The goal is to have patients learn what relaxed muscles feel like while following the tape and be able to relax them in the real world when they feel stressed. The more patients practice and perform these techniques, the more relaxed they can become.

Some patients with OCD will get extremely anxious (eg, sweat, have palpitations) when they are in situations that provoke their OCD fears. For example, a patient of mine with contamination fears had a lot of trouble at work when colleagues would pat him on the back. Since he could not avoid this or immediately leave and wash his clothing, it was helpful for him to learn relaxation techniques to help him to control his anxiety in these situations. He learned deep breathing, so as soon as he started to feel symptoms of anxiety he would take a few deep breaths. This often turned the situation around and enabled him to stay and behave appropriately. Relaxation training is not going to cure the disorder, but it can make unavoidable situations more manageable. Training patients to be aware of their anxiety early is key. If they wait until they are already panicking, then the techniques are not as effective.

 

Does CBT help people realize that their symptoms result from the illness?

Yes. Most patients with OCD have fairly good insight. However, when they are faced with a scary situation, a contamination situation, or a situation wherein they think they did not turn off the stove, they might lose their insight in those moments and think there is real danger. If patients completely lack insight, it presents real problems in treatment, but it is more likely for insight to be a problem in OCD situations.

It is very valuable for patients both to know that their symptoms result from OCD and to be able to identify the specific thoughts and behaviors related to the disorder. Some patients might not know about OCD; they may think they are going crazy. When a clinician educates the patient about OCD, it can be reassuring to find out what the problem is and that there is a name and treatment for it. In addition, I typically use a cognitive assignment wherein people label their OCD thoughts and behaviors to help them become aware of when their thoughts and behaviors are an expression of their OCD. Over time, labeling helps patients with OCD to recognize that a thought or behavior is OCD rather than a realistic concern or reaction, ultimately helping them to be less upset by their intrusive thoughts and to resist performing their rituals.

 

Do symptoms get worse during the course of treatment as the patient attempts to alter behavior or thoughts?

When patients are in CBT, the exposure and response prevention exercises will be more stressful than the same situation would be if the patient just went ahead and performed an OCD ritual; that is to be expected and the patients should be educated to understand that. However, trying to do too much too quickly can be a problem. It is important to make sure that the exposures are not too stressful for the patient. The goal is for the exposures to be tolerable, to increase anxiety but not so much that the patient will resort to a ritual to reduce his or her anxiety; this is considered necessary for exposure and response prevention to succeed in reducing OCD symptoms. An exposure can backfire if it is too severe because the patient can get extremely upset, lose confidence in the technique, or even leave therapy. Having patients work on too many things simultaneously can also be a problem; a realistic plan of action should be created. If a patient tries to stop performing many rituals at the same time, the patient’s likelihood of success is lowered. For example, when a person decides to go to the gym every morning before work to get in better shape, he or she most likely will not stick to that plan. A more realistic exercise plan would have a better chance of being carried out.

Sometimes, symptoms will worsen during a fairly typical treatment. For example, the patient may have successfully reduced his or her checking the stove as part of an assignment but may find he or she is checking something else such as the windows to make sure they are locked. This situation does not usually create a problem, despite the worsening symptoms. Once they realize that another symptom is increasing, patients can usually reduce the behavior back to the baseline level and keep it there; if not, the increased symptoms can be specifically targeted in therapy. In my experience, a significant worsening in symptoms that cannot be easily reversed is usually due to one of three factors. First, another stressor could be increasing the OCD in general. Second, the patient could be completing assignments incorrectly and inadvertently reinforcing the OCD. Third, the patient may be at a major point of improvement and is getting anxious about that.

 

Is there a specific time course for treatment with CBT?

It is reasonable to expect to see improvement in as early as 3–4 weeks. If the patient is completing the assignments and the exposures, then he or she is going to benefit from therapy. Whenever a patient cannot complete an assignment, the patient and the therapist need to trouble shoot to figure out what might be interfering. If the patient is still not able to complete assignments after the first 3–4 weeks, the therapist has to consider the problem and discuss it with the patient in terms of possible treatment options. For example, it is possible that a medication could help the patient tolerate exposures. If a patient does not want to go on medication, the therapist can negotiate with him or her. The therapist could suggest that the patient try the exposures without medication for a few more weeks, but if the patient is still not able to do the exposures within that time period then medication will become part of treatment. That may motivate the patient to do the exposures.

Certainly after 6–8 weeks patients should notice that they can manage specific situations better, though they may not feel that the disorder is markedly improved. Results show quickly, but most studies are conducted within 12 weeks, which is not adequate time for treatment in most OCD cases. A clinically meaningful response will be found in that period of time, but there will be many residual symptoms. In private practice, I would generally recommend much longer treatment in order to do a better job of getting rid of symptoms.

 

How would the importance of consistent reinforcement versus intermittent reinforcement impact the treatment negatively or positively?

I think consistency is very important. There is a long line of basic learning research13 that shows things learned with random, intermittent reinforcement are very difficult to extinguish. For example, in some research conducted using rats, the researchers would train rats to press a lever to get a piece of kibble. Using continual reinforcement, the rat would get a piece every time they pressed the lever. Using random, intermittent reinforcement, the rats receive a piece of kibble unpredictably; the outcome of pressing the lever is unpredictable. Other rats might be given kibble consistently, say every tenth time the lever was pressed. When the researchers stopped feeding them, the rats that were fed on the random intermittent reinforcement schedule continued to press the lever for food for much longer than rats in any of the other conditions; the rats that were fed every time they pressed the lever stopped pressing the quickest. The lever pressing behavior was much more difficult to extinguish in the random, intermittently fed rats.

In OCD, the concept of intermittent reinforcement can easily be applied to reassurance seeking. OCD patients will often ask their families for reassurance (eg, whether something is contaminated), and families will reassure them to calm them, thus unknowingly reinforcing the OCD. If families realize this is reinforcing the disorder, they may attempt to stop it. However, they are often inconsistent in doing so. For example, patients may beg their families for reassurance and the families may occasionally give in and provide this reassurance. Based on learning theory, this is going to make patients continue to seek reassurance and it will be even more difficult to extinguish than if they had kept reassuring them continuously. That is, OCD patients will continue to ask for reassurance because it succeeds; they get the reassurance and it calms them for the moment. Importantly, not getting reassurance on a particular occasion will just make them ask more because they have learned that they will get reassurance eventually.

In addition, since the families are most likely to give in when the patient is upset and out of control, the patient’s more extreme behavior is selectively reinforced. Not only is the patient going to continue to ask for reassurance, but the intensity of the requests will increase since that is what is being reinforced and that is what persuades the family.

This can also be applied to situations in which a patient tries to resist performing rituals. The patient will resist until he or she cannot take it anymore. When the individual can no longer take it, he or she will give in to the urges and perform the behavioral rituals. The OCD urges are reinforced intermittently. However, there is a pattern—the more intense a patient’s OCD distress, the more likely he or she is to give in and perform the ritual, so the OCD is strongly reinforced. This is common among patients who try to apply CBT on their own. Numerous patients believe that CBT does not work based on their efforts to stop their rituals on their own. However, that is only because they intermittently reinforced the disorder.

It is common for OCD patients to seek reassurance from their clinicians and it is important for the clinicians to avoid reinforcing their patients’ OCD. I usually tell obsessive patients that they cannot ask repeat questions during phone calls or therapy sessions. They can ask any question once, including matters concerning particular side effects or whether or not something is OCD or is really dangerous. An obsessive patient can be very repetitive, and this is harmful to them. If a patient asks a question once and repeats it, a therapist should remind him or her that the question has already been answered, but that is all that should be done. The patient should not get to ask that question anymore. In explaining that to the patient, I emphasize how repeating questions is not good for them, not that it is bothersome. I tell them that performing these rituals reinforces their OCD and that I cannot be complicit to worsening their condition. PP

 

References

1. Marks IM, Hodgson R, Rachman S. Treatment of chronic obsessive-compulsive neurosis by in-vivo exposure: a two-year follow-up and issues in treatment. Br J Psychiatry. 1975;127:349-364.
2. Roper G, Rachman S, Marks I. Passive and participant modelling in exposure treatment of obsessive-compulsive neurotics. Behav Res Ther. 1975;13(4):271-279.
3. Lindsay M, Crino R, Andrews G. Controlled trial of exposure and response prevention in obsessive-compulsive disorder. Br J Psychiatry. 1997;171:135-139.
4. Nakatani E, Nakagawa A, Nakao T, et al. A randomized controlled trial of Japanese patients with obsessive-compulsive disorder–effectiveness of behavior therapy and fluvoxamine. Psychother Psychosom. 2005;74(5):269-276.
5. Marks IM, Baer L, Greist JH, Park JM, et al. Home self-assessment of obsessive-compulsive disorder. Use of a manual and a computer-conducted telephone interview: two UK-US studies. Br J Psychiatry. 1998;172:406-412.
6. Greist JH, Marks IM, Baer L, et al. Behavior therapy for obsessive-compulsive disorder guided by a computer or by a clinician compared with relaxation as a control. J Clin Psychiatry. 2002;63(2):138-145.
7. Baxter LR Jr, Schwartz JM, Bergman KS, et al. Caudate glucose metabolic rate changes with both drug and behavior therapy for obsessive-compulsive disorder. Arch Gen Psychiatry. 1992;49(9):681-689.
8. Schwartz JM, Stoessel PW, Baxter LR Jr, Martin KM, Phelps ME. Systematic changes in cerebral glucose metabolic rate after successful behavior modification treatment of obsessive-compulsive disorder. Arch Gen Psychiatry. 1996;53(2):109-113.
9. van Oppen P, de Haan E, van Balkom AJ, Spinhoven P, Hoogduin K, van Dyck R. Cognitive therapy and exposure in vivo in the treatment of obsessive compulsive disorder. Behav Res Ther. 1995;33(4):379-390.
10. van Balkom AJ, de Haan E, van Oppen P, Spinhoven P, Hoogduin KA, van Dyck R. Cognitive and behavioral therapies alone versus in combination with fluvoxamine in the treatment of obsessive compulsive disorder. J Nerv Ment Dis. 1998;186(8):492-499.
11. Cottraux J, Note I, Yao SN, et al. A randomized controlled trial of cognitive therapy versus intensive behavior therapy in obsessive compulsive disorder. Psychother Psychosom. 2001;70(6):288-297.
12. Whittal ML, Thordarson DS, McLean PD. Treatment of obsessive-compulsive disorder: cognitive behavior therapy vs. exposure and response prevention. Behav Res Ther. 2005;43(12):1559-1576.
13. Skinner BF. The Behavior of Organisms: An Experimental Analysis. Oxford, England: Appleton-Century; 1938.

e-mail: ns@mblcommunications.com

 

Dr. Sussman is editor of Primary Psychiatry and professor of psychiatry at the New York University School of Medicine in New York City.

Dr. Sussman reports no affiliation with or financial interest in any organization that may pose a conflict of interest.

 


 

Unlike most issues of Primary Psychiatry, the focus this month is on a specific clinical facility rather than particular diseases and treatments. In deciding to devote this issue to a discussion of the Stephen D. Hassenfeld Children’s Center for Cancer and Blood Disorders (SDHCC) at the New York University (NYU) Langone Medical Center in New York City, it is hoped that many readers who are in a position to influence decisions and funding involving clinical services for children and young adults will use the SDHCC model to create similar programs in their communities. While all centers endeavor to provide excellent, state of the art medical care, sometimes sensibilities about environment in which services are provided can be left wanting.

Often, when dealing with life-threatening illnesses, so much emphasis is given to the medicine regimen or surgical interventions that resources are not provided psychosocial support. This can be due to lack of funding or the lack of priority given to non-essential infrastructure and services. In the case of the SDHCC, which treats children with cancers and blood disorders (including brain tumors, bone and soft tissue sarcomas, leukemia, vascular malformations and other diseases of the blood such as platelet and blood-clotting disorders), the reaction of patients, their families, and the staff strongly support the value of the comprehensiveness of services in one site and the emphasis of complementary interventions in improving the quality of life for these young patients. The staff is committed to providing compassionate care to both the physical and emotional needs of the pediatric patients and their families.

The SDHCC was named in memory of Stephen D. Hassenfeld, Chairman of Hasbro, Inc., the famous toy company. He was also founder of the Hasbro Children’s Foundation. The mission of the SDHCC is to provide the best possible research-driven care in a compassionate and respectful manner to all children in need regardless of financial ability.

Patients not only benefit from the results of nationally established protocols, but also have immediate access to original research pioneered by physicians in areas such as stem cell transplantation and interferon therapy.

Anyone, young or old, who has experienced a serious illness themselves or in a family member probably knows how frightening visits to the doctor, hospital, or laboratory can be. At its worst, the visits can be dehumanizing, as the patient sits in a waiting room reading old magazines, then goes into a windowless room for an examination or test. Most often one then needs to go to a separate lab for blood work. Typically, care and visits are not coordinated; patients and companions may be inconvenienced as visits may be spread out at several sites over several days. Apart from the uplifting decor and thoughtful use of space at the SDHCC, the various specialties utilize an integrated multi-disciplinary model to provide comprehensive and individualized care. A behavioral health team endeavors to facilitate normal development in spite of the serious illness and the impact of treatment as well as to enhance the patients’ and families’ ability to understand the illness and handle the many emotions that can accompany it.

As described at the center’s Web site:

 

Our psychiatrists, psychologists, social workers and child life specialists help children and family members recognize important and often confusing feelings that may be difficult to express. The team uses an array of specialty services including neuropsychological and educational evaluations for appropriate school placement; “medical play” to help children achieve a sense of mastery and control over their situation; creative arts therapies that allow for nonverbal expression of feelings; and individual and group counseling to teach coping strategies.1

The SDHCC has playroom space for play therapy activities, a video room for watching movies, and comfortable private room for treatments that take several hours. Having an on-site laboratory provides physicians with immediate results and streamlines appointment times.

This issue is not intended as a public relations piece for the SDHCC. Any conflict of interest I might have as editor of this journal is that I am affiliated with the NYU Langone Medical Center. I extend an invitation to our readers to submit information about other programs around the country that provide comprehensive medical care accounting for psychiatric, social, and cultural needs of patients and their families. We will consider it as the focus of a future issue of Primary Psychiatry. PP

 

Reference

1.    Stephen D. Hassenfeld Children’s Center for Cancer and Blood Disorders. Available at: www.med.nyu.edu/hassenfeld. Accessed June 12, 2008.

 

 

e-mail: ns@mblcommunications.com

 

Dr. Sussman is editor of Primary Psychiatry and professor of psychiatry at the New York University School of Medicine in New York City.

Dr. Sussman reports no affiliation with or financial interest in any organization that may pose a conflict of interest.

 


 

An understanding of the etiology of schizophrenia has eluded theoreticians and investigators for centuries. The question of whether it is possible to recover from the disorder has also proven to be frustrating to those seeking an understanding of the true course of the illness. Three of the feature articles in this issue of Primary Psychiatry provide overviews of some of the most important recent findings about these issues.

Mark G. A. Opler, PhD, and colleagues present some of the more significant findings on schizophrenia. They note how there are multiple pathways to schizophrenia that may be reflected in neurobiologic differences, the heterogeneous clinical presentation of the disease, and in differential responses to treatment. Several findings about factors that increase risk have been confirmed. These include genes, particularly the evidence for genetic associations and the function of suspected susceptibility genes; advanced paternal age and potential mechanisms by which it exerts its influence on pathology; and selected environmental exposures, such as chemicals and poor nutrition. This article also reviews likely gene-gene and gene-environment interactions.

Cannabis, or marijuana, is the most widely used illegal drug in the United States, with nearly 45% of teenagers in the US having smoked cannabis before graduation from high school. Smoking cannabis is also common among young adults. It is viewed by many as a relatively benign recreational drug, but compelling evidence has implicated cannabis as a possible cause of schizophrenia. Despite the social acceptance of cannabis use, in part because there is a pervasive belief that cannabis use is benign, cannabis use can lead to psychosis. Lauren L. Bodkin, PsyD, and colleagues describe what may make some teenagers vulnerable to psychosis in the context of cannabis use, considers motivations for their use, and makes recommendations for treatment approaches to be used by clinicians, as based on the existing literature. They describe a particularly vulnerable subset of youths who possess a genetic variation that manifests in particular behaviors and experiences, including schizotypy. Apart from the psychiatric dimension of chronic cannabis use, the authors note, it has been estimated that smoking five joints/day may be equivalent to smoking one pack of cigarettes/day in terms of exposure to cancer-causing chemicals. In addition to outlining the varied risks associated with cannabis use, the article contains useful guidelines for intervention when clinicians encounter patients at elevated risk.

Paul H. Lysaker, PhD, and Kelly D. Buck, APRN, BC, summarize the results of data from multiple sources and observe that many psychiatric and general practitioners remain unaware that most people with schizophrenia will achieve significant periods of recovery during their lives. The authors note that while these data are grounds for optimism, the idea of recovery has been received with resistance and as an evolving concept it has yet to be defined in an agreed upon matter. Progressive deterioration was long considered a hallmark of schizophrenia, but evidence suggests that this is more the exception than the rule. Examples of recovery as a process include the resolution of problems associated with the illness, the development of an optimistic outlook on life, and the development of a sense of worth and intrinsic value. The article clarifies the concept of recovery and its implications for practice, and offers a review of definitions, operational criteria, and studies of the incidence and correlates of recovery from schizophrenia. They conclude with a review of clinical practices that might be employed to promote recovery. Even though gains are often followed by losses and relapse, the authors argue that these may become opportunities for insight and personal growth.

Mark Zimmerman, MD, and colleagues note that to determine the impact of treatment in clinical practice it is necessary to evaluate outcome. At the moment, assessments of outcome are typically based on unstructured interactions that yield unquantified judgments of progress. Even among psychiatrists, use of standardized scales to monitor outcome is rare. The authors explain why available self-report questionnaires are a cost-effective option to monitor outcome. They state that standardized scales should be routinely used to measure outcome when treating depression and that this should be the standard of care. They conclude with a challenge to readers who are not convinced by their arguments and who do not adopt a measurement-based approach toward treating depression. PP

 

This interview took place on March 31, 2008, and was conducted by Norman Sussman, MD.

 

This interview is also available as an audio PsychCastTM at http://psychcast.mblcommunications.com.

Disclosure: Dr. Mathew receives research support from the General Clinical Research Center, the National Alliance for Research on Schizophrenia and Depression, and the National Institute of Mental Health. Dr. Mathew has been named as an inventor on a use-patent of ketamine for the treatment of depression. If ketamine were shown to be effective in the treatment of depression and received approval from the Food and Drug Administration for this indication, Dr. Mathew could benefit financially.

 

Dr. Mathew is assistant professor of Psychiatry at the Mount Sinai School of Medicine (MSSM) in New York City. A board-certified psychiatrist, Dr. Mathew is also attending physician in the Mood and Anxiety Disorders Program at the Mount Sinai Medical Center.  In 2007, he received the American Foundation for Suicide Prevention Pfizer Travel Award as well as the Lamport Research Award from MSSM. In addition to therapeutic approaches for treatment-resistant depression and anxiety, Dr. Mathew’s research involves magnetic resonance imaging and spectroscopy applications to anxiety and mood disorders.

 

What is the basis for the undertaking of this research?

There has been approximately 30 years of research looking at ketamine as a probe for glutamate function and as a possible pharmacologic model for psychosis. In the early 1990s, John Krystal, MD, and several others discovered that ketamine can model the acute positive symptoms, negative symptoms, and cognitive disruptions observed in schizophrenia.1-3 As a result, injecting healthy volunteers with ketamine and having them perform a variety of cognitive tasks was believed to reflect schizophrenic pathology better than amphetamine-induced psychoses.

In the late 1990s, an attempt was made to further understand the ketamine response in major depressive disorder (MDD). At that time, studying patients with MDD was thought to expand understanding of the N-methyl-D-aspartate (NMDA) receptor hypofunction.

 

How does NMDA relate to the monoamine neurotransmitters in antidepressants?

Glutamate receptors can classified as ionotropic receptors, and NMDA is one of them. There are other ionotropic receptors, including kainate and a-amino-3-hydroxy-5-methyl-4-isoxazole propionate (AMPA). Ionotropic receptors mediate fast receptor transmission and use-dependent changes required for brain plasticity. They are important for a host of normal functions such as cognition and learning.

It has been challenging to identify pharmacologic targets that do not result in seizure, stroke, or other sequelae of NMDA overactivity. However, newer drugs and approaches (eg, ketamine) have shown to be interesting and useful because NMDA and glutamate are found in 85% of circuits in the central nervous system (CNS). However, identifying subtype-selective and safe ligands of this system has been difficult. Glutamate is a ubiquitous system, but with its ubiquity comes the risk of overtoxicity.

 

What attracted people to ketamine?

Ketamine binds at the site of the NMDA receptor similarly to phencyclidine. Physicians are attracted to ketamine for numerous reasons. In psychiatric research, it was a good model for understanding glutamate and the NMDA receptor relevant to schizophrenia. In the 1960s, the drug was used for anesthetic purposes primarily in children. However, it was used in adults undergoing orthopedic procedures and in the field of gynecology as well. In addition, that ketamine is neither associated with significant side effects nor known to have a short half-life contributes to its popularity.

 

Was a psychiatric therapeutic response observed when ketamine was used as an anesthetic?

Yes. The doses were approximately 4–5 times higher than the current doses used to manage MDD. The most notable symptoms were emergence type reactions of dissociation, particularly in children emerging from the anesthesia. Ketamine was not systematically tracked to their mood, and that they were feeling better within the next 1–3 days was not systematically described. There have been reports in the pain literature that patients given ketamine for chronic refractory pain syndromes (eg, cancer-related pain) felt better in terms of their mood. However, tracking them long term for changes in depressive symptoms had not been conducted.

 

Is there a connection between the glutamate system and monoamine neurotransmitters?

Connections are directly observed in both animal models and human imaging models. For example, selective serotonin reuptake inhibitors (SSRIs) used in depression, anxiety, and obsessive-compuslive disorder (OCD) have been found to decrease glutamate regulation in specific areas.

Rosenberg and colleagues4 looked at glutamate signaling in caudate. They found overactivity in OCD and a down-modulation with subsequent SSRI treatment. The results showed that SSRIs and other serotonergic drugs could dampen overactivity of glutamate.

Conversely, γ-aminobutyric acid (GABA) is the major inhibitory amino acid that counterbalances some of the glutamatergic overactivity. SSRIs have been found to increase GABA.5 It is possible that established monoaminergic treatments work in both respects by decreasing overactivity and increasing the underactive GABA. In animal models, numerous examples show the connections between serotonin postsynaptic receptors (eg, 5-HT2A receptor) and specific components of the glutamate system.

 

Which drugs are major topics in research?

Of the Food and Drug Administration’s currently available drugs, investigators have been interested in acamprosate, lamotrigine, memantine, riluzole, and topiramate.

Riluzole is the only treatment approved for Lou Gehrig’s disease. It is a glutamate-release inhibitor that is believed to have AMPA receptor activity as well as the capability of increasing the reuptake into glial cells; the net effect could be neuroprotection. Topiramate is a well-described anticonvulsant with AMPA kainate receptor activity. The antiviral, amantadine, has been found to have weak NMDA activity, meaning it is a partial NMDA antagonist. Memantine, which is approved for Alzheimer’s disease, is an NMDA antagonist, but it is a lower affinity than ketamine. Acamprosate is believed to have glutamate activity. It works on the metabotropic glutamate (mGlu) receptor system as an antagonist. Lamotrigine, possibly the best-described drug for bipolar depression, has shown evidence of anti-glutamatergic activity.

 

Have the preliminary reports of D-cycloserine shown a pharmacologic spectrum different from other drugs in theory?

D-cycloserine is a partial NMDA agonist that works at the D-serine site on the NMDA channel. The theoretical rationale behind D-cycloserine is not an excitotoxicity neuroplasticity model, but an enhancement of extinction learning model. By itself, D-cycloserine does not appear to be anxiolytic or antidepressant. However, in conjunction with active forms of learning and extinction type psychotherapies (eg, prolonged exposure to social anxiety disorder, acrophobia, or height phobia), D-cycloserine co-administration results in more rapid improvements, particularly in extinguishing the stressor or the fear. The theory behind D-cycloserine capitalizes on the mechanisms of extinction learning as opposed to decreasing excitotoxicity and enhancing resilience.

 

Which FDA-approved drugs look most promising for clinical use?

The FDA-approved drug with the most momentum in terms of the data in treatment-resistant depression (TRD) is riluzole. At least two open-label studies in TRD involved patients who had not responded to ≥2 standard antidepressants.6,7 The National Institute of Mental Health (NIMH) is reviewing a grant that will determine whether or not there is a role for riluzole adjunctive therapy in unipolar depression.

A small study by Zarate and colleagues8 showed memantine to have negative effects in unipolar depression. However, there is still much interest in memantine, as this study involved a relatively small sample size and efficacy with dosing >20 milligrams was not measured. While acamprosate is being explored for off-label uses in depression and anxiety, ketamine is being looked at as an experimental model for acute treatment of depression. Ketamine is not being studied for its long-term potential outside of the hospital setting, but those studies are going to be ongoing.

 

Which patients would benefit from these treatments?

It is premature to discuss who would benefit from ketamine at this time as the numbers treated are extremely low. Further controlled investigations are necessary. Work is ongoing to uncover moderators and mediators of response to intravenous ketamine and similar approaches

In addition, the pilot data9 suggests that anxious and depressive patients would benefit from glutamate-modulating agents. According to results from the Sequenced Treatment Alternatives to Relieve Depression study,10 anxious depression is a risk factor for resistance and nonresponse to citalopram as well as augmentation strategies.

There is open-label evidence of efficacy of riluzole in OCD; however, there is no placebo-controlled data at this time.11,12
Topiramate has successfully treated patients for self-mutilation in OCD and borderline personality disorder, possibly due to topiramate’s benefits in the spectrum of compulsive-impulsive disorders (eg, binge eating disorder).

 

What are the risks associated with the use of these drugs?

The acute risks with intravenous infusion of ketamine include dissociation, described as having a sense of altered time, feeling light, or feeling outside a person’s body. These side effects tend to be transient and time limited. The patients we have studied have not had side effects beyond 2 hours following intravenous infusion.

There are some reports in the literature of frank psychosis and auditory hallucinations,13 but with the dose given (ie, approximately 25% the anesthetic dose), neither auditory nor visual hallucinations were seen. However, this is still something of which to be aware. As there are transient increases in blood pressure, patients with uncontrolled hypertension are not recommended for the treatment. In addition, this medication is given by anesthesia, meaning there is potential aspiration risk. Therefore, patients with inadequately treated gastroesophageal reflux disease are excluded.

 

Are neurokinin (NK)1 antagonists and corticotropin-releasing factor (CRF) antagonists moving ahead in as promising a way as glutamate?

Mount Sinai Medical Center is investigating both of those compounds. The NK1 receptor antagonist is being looked at in posttraumatic stress disorder (PTSD). The rationale pre-clinically and clinically is that substance P, which is a stress-related neuropeptide, is elevated in the cerebrospinal fluid of veterans with PTSD, and NK1 receptor activity has been co-localized in regions important in stress. The NK1 receptor is an attractive target in that it is a stress-related neuropeptide implicated in fear and anxiety as well as mood circuitry. Numerous companies have developed NK1 antagonists and are now hitting Phase II and even Phase III studies.14 CRF has been in the news and on the horizon for >10 years. A CRF-1 selective antagonist for the treatment of PTSD is being investigated, and numerous studies have examined this mechanism in patients with anxiety and depressive disorders.15 Although NK1 and CRF antagonists have been heavily considered, it has been difficult to have one of these drugs receive FDA approval. In fact, a Phase II study of a selective CRH-1 antagonist was just published and found lack of efficacy of this agent for major depression.16

 

Have other drugs been developed that are more practical in terms of administration or safety?

There has been a lot of interest in an experimental MGlu receptor agonist drug called LY2140023. In a recently published study, the drug performed better than placebo and was as effective as olanzapine, suggesting that LY2140023 has antipsychotic properties. This may have several implications in terms of new directions in schizophrenia and psychosis. Drugs similar to mGlu drugs have preclinical and clinical evidence of utility in depressive and anxiety disorders.

In terms of ease of use and safety, only time will tell. The preclinical safety data for one of the compounds was not favorable, and that development was halted due to seizures. However, more clinical testing needs to be conducted.

 

Do you expect any major study results on these drugs to be published or presented in the near future?

The mGlu family has numerous exciting and interesting compounds one should expect to hear about next year. In addition, ampakines, which are AMPA receptor potentiators, are being studied for cognitive deficits in schizophrenia, memory disorders, and MDD. One should also expect to hear about NMDA receptor 2B antagonists, which are subtype selective NMDA receptor antagonists, as Zarate and colleagues are performing studies on them at the NIMH.

 

Is there a number at Mount Sinai Medical Center to which anyone interested in exploring participation or referring a patient should call?

If anyone is interested, they can call 212-241-4480, and we would be happy to discuss any of the specifics of participation.

 

Is there anything you would like to add?

Although there is a lot of excitement about ketamine and the rapidity of onset, the NIMH has recently funded us to perform a definitive clinical trial comparing ketamine to an active control, as that has not been done to date. At this point, it is important to not go beyond the data and suggest ketamine is appropriate for treatment. Caution should be taken until more data emerges. PP

 

References

1.    Javitt DC, Zukin SR. Recent advances in the phencyclidine model of schizophrenia. Am J Psychiatry. 1991;148(10):1301-1308.
2.    Krystal JH, Karper LP, Seibyl JP, et al. Subanesthetic effects of the noncompetitive NMDA antagonist, ketamine, in humans. Psychotomimetic, perceptual, cognitive, and neuroendocrine responses. Arch Gen Psychiatry. 1994;51(3):199-214.
3.    Lahti AC, Koffel B, LaPorte D, Tamminga CA. Subanesthetic doses of ketamine stimulate psychosis in schizophrenia. Neuropsychopharmacology. 1995;13(1):9-19.
4.    Rosenberg DR, MacMaster FP, Keshavan MS, Fitzgerald KD, Stewart CM, Moore GJ. Decrease in caudate glutamatergic concentrations in pediatric obsessive-compulsive disorder patients taking paroxetine. J Am Acad Child Adolesc Psychiatry. 2000;39(9):1096-1103.
5.    Sanacora G, Mason GF, Rothman DL, Krystal JH. Increased occipital cortex GABA concentrations in depressed patients after therapy with selective serotonin reuptake inhibitors. Am J Psychiatry. 2002;159(4):663-665.
6.    Sanacora G, Kendell SF, Levin Y, et al. Preliminary evidence of riluzole efficacy in antidepressant-treated patients with residual depressive symptoms. Biol Psychiatry. 2007;61(6):822-825.
7.    Zarate CA Jr, Payne JL, Quiroz J, et al. An open-label trial of riluzole in patients with treatment-resistant major depression. Am J Psychiatry. 2004;161(1):171-174.
8.    Zarate CA Jr, Singh JB, Quiroz JA, et al. A double-blind, placebo-controlled study of memantine in the treatment of major depression. Am J Psychiatry. 2006;163(1):153-155.
9.    Mathew SJ, Amiel JA, Coplan JD, Fitterling H, Sackeim HA, Gorman JM. Open-label trial of riluzole in generalized anxiety disorder. Am J Psychiatry. 2005;162(12):2379-2381.
10.    Fava M, Rush AJ, Alpert JE, et al. Difference in treatment outcome in outpatients with anxious versus nonanxious depression: a STAR*D report. Am J Psychiatry. 2008;165(3):342-351.
11.    Grant P, Lougee L, Hirschtritt M, Swedo SE. An open-label trial of riluzole, a glutamate antagonist, in children with treatment-resistant obsessive-compulsive disorder. J Child Adolesc Psychopharmacol. 2007;17(6):761-767.
12.    Coric V, Taskiran S, Pittenger C, et al. Riluzole augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. Biol Psychiatry. 2005;58(5):424-428.
13.    Okon T. Ketamine: an introduction for the pain and palliative medicine physician. Pain Physician. 2007;10(3):493-500.
14.    Mathew SJ, Manji HK, Charney DS. Novel drugs and drug targets for severe mood disorders. Neuropsychopharm. 2008. In press.
15.    Binneman B, Feltner D, Kolluri S, Shi Y, Qiu R, Stiger T. A 6-week randomized, placebo-controlled trial of CP-316,311 (a selective CRH1 antagonist) in the treatment of major depression. Am J Psychiatry. 2008. In press.
16.    Patil ST, Zhang L, Martenyi F, et al. Activation of mGlu2/3 receptors as a new approach to treat schizophrenia: a randomized Phase 2 clinical trial. Nat Med. 2007;13(9):1102-1107.

 

Dr. Zimmerman is director of Outpatient Psychiatry at Rhode Island Hospital and associate professor in the Department of Psychiatry at Brown Medical School in Providence, Rhode Island. Drs. McGlinchey and Chelminski are assistant clinical professors in the Department of Psychiatry and Human Behavior at Brown University.

Disclosure: The authors report no affiliation with or financial interest in any organization that may pose a conflict of interest.

Please direct all correspondence to: Mark Zimmerman, MD, Associate Professor, Department of Psychiatry, Brown Medical School, Bayside Medical Building; 235 Plain Street; Providence, RI 20905; Tel: 401-277-0724; Fax: 401-277-0726; E-mail: mzimmerman@lifespan.org.

 


 

Focus Points

• In mental health clinical settings, assessments of outcome are typically based on unstructured interactions that yield unquantified judgments of progress.
• The results of two surveys found that psychiatrists typically do not use standardized scales of established reliability and validity to monitor outcome when treating patients with depression.
• Self-report questionnaires are cost-effective options to monitor outcome because they are inexpensive in terms of professional time needed for administration and they correlate highly with clinician ratings. 
• Brief self-report scales are reliable and valid measures of depression and are feasible to incorporate into routine clinical practice.

 


 

Abstract

Psychiatry is the only medical discipline in which quantified measurements of outcome are not the standard of care. In mental health clinical settings, outcome evaluations are typically based on unstructured interactions that yield unquantified judgments of progress. This is at variance with other areas of medical care in which outcome is partially determined by the change of a numerical value. Body temperature, blood pressure, cholesterol values, blood sugar levels, cardiac ejection fraction, and white blood cell counts are examples of quantifiable variables that are used to evaluate treatment progress. In treating psychiatric disorders, standardized, quantifiable outcome measures exist for most major psychiatric disorders, yet they are rarely used in routine clinical practice. Recently, the term “measurement-based care” has been coined in reference to the use of standardized scales to measure the outcome of psychiatric treatment. This article  reviews perceived obstacles in adopting a measurement-based care treatment approach and illustrates how the use of self-report depression scales is feasible, acceptable to patients, and may improve outcome.

Introduction

Imagine a patient going to his or her primary care physician (PCP) with symptoms of an upper respiratory track infection and a feverish feeling. Imagine the PCP placing his or her palm on the patient’s forehead and telling the patient that he or she feels warm. Imagine the PCP recommending both a course of treatment and a return visit in a few days. A few days later, the PCP again feels the patient’s forehead and notes improvement because the patient feels cooler. It is likely that a PCP who evaluated body temperature in this manner would soon be out of business.

To determine the impact of treatment, it is necessary to evaluate outcome. In mental health clinical settings, this typically is based on unstructured interactions that yield unquantified judgments of progress. Often judgments of outcome are based on broad-based, global questions such as “How are you feeling?” or “How are you doing?” These inquiries are similar to everyday discourse when greeting a friend or acquaintance. Correspondingly, patients often reply with global, ofttimes misleading, responses such as “okay” or “fine.” There have been patients who, at the beginning of the visit, indicate that they are “fine,” and by the end of the visit, it is agreed that hospitalization is warranted.

When treating depression, competent clinicians do not limit their assessments of outcome to global questions. Instead, they follow up with specific questions about the defining features of the disorder they are treating, including the symptoms of depression and domains of psychosocial functioning. However, even these questions are not usually used to evaluate outcome in a quantified manner. This is at variance with other areas of medical care in which outcome is partially determined by the change of a numerical value. Body temperature, blood pressure, cholesterol and triglyceride values, blood sugar levels, pulmonary function tests, electrolytes, cardiac ejection fraction, and white blood cell counts are examples of quantifiable variables used to evaluate treatment progress. In the mental health field, standardized, quantifiable outcome measures exist for most major psychiatric disorders, yet they are rarely used in routine clinical practice.

The authors believe that standardized scales should be routinely used to measure outcome when treating depression. In fact, the authors believe that this should be the standard of care. The goal of this article is to review recent research related to the use of depression rating scales in routine clinical practice. First, the authors discuss a potentially important reason for systematic measurements (ie, the detection of residual symptoms in patients who have improved but not remitted from treatment). Second, they summarize the results of two surveys of psychiatrists’ use of scales to measure outcome. Third, they review the desirable features of a depression outcome scale. Fourth, they summarize research conducted in their clinical-research program on the reliability and validity of a self-administered scale that was designed with clinical utility in mind. Fifth, they summarize research on patients’ perspectives of the burden associated with completing scales in clinical practice. Last, they summarize the results of a research program that has demonstrated the therapeutic benefits of measurement in patients receiving psychotherapy.

 

One Reason Why Measurement May Be Important in Treating Depression: Improved Detection of Residual Symptoms

Measurement provides the clinician with information regarding the degree and completeness of treatment success. Suboptimal outcome in the treatment of diabetes, hypertension, hypercholesterolemia, or an infection would prompt intervention. For example, improvement in blood pressure from 165/105 to 145/95 is a positive yet incomplete response that would warrant an adjustment in treatment. Likewise, reducing total cholesterol from 280 to 240 is movement in the right direction, but it is insufficient and requires a change in treatment. The same should be true in the treatment of depression.

Research has consistently demonstrated that residual symptoms of depression in patients who have responded to treatment are at increased risk for relapse. For example, Paykel and colleagues1 followed up 64 treatment responders for 15 months. Patients who scored >8 on the Hamilton Rating Scale for Depression (HAM-D)2 (ie, nonremitters) were three times more likely to relapse during the follow-up interval than patients scoring ≤8 (76% versus 25%). Numerous follow-up studies3-9 have similarly found that the presence of residual symptoms in patients who responded to treatment robustly predicted poorer outcome.

How well do clinicians detect such residual symptoms? There are no studies that address this question. However, as described below, one research group has demonstrated that measuring outcome and providing feedback to treating clinicians significantly improved outcome.

 

Surveys of Psychiatrists’ Use of Standardized Scales to Measure Outcome

Gilbody and colleagues10 surveyed 340 psychiatrists in the United Kingdom regarding their use of outcome measures. Only 11.2% of psychiatrists routinely used standardized measures to assess outcome when treating depression and anxiety disorders. Greater than 50% of clinicians indicated that they never used standardized measures to evaluate outcome. The authors did not ask the respondents why they were disinclined to use scales to measure outcome; however, they noted that several respondents included comments on the questionnaires indicating that they thought such scales were simplistic, not useful in clinical practice, of questionable reliability and validity, or overly burdensome and costly to implement routinely.

Zimmerman and McGlinchey11 conducted a similar survey of 314 psychiatrists in the United States. Prior to delivering a lecture on the treatment and management of depression at continuing education conferences in California, Massachusetts, New York, and Wisconsin, audience members were asked to complete a brief questionnaire. The first part of the questionnaire elicited subjects’ demographic characteristics (ie, age, sex) and professional background (ie, practice setting and years in practice). The second part of the questionnaire included six questions, two of which addressed the use of rating scales. The first question was, “How often do you use a rating scale to monitor the course of treatment for depression?” Response choices included, “never,” “rarely,” “sometimes,” “frequently,” and “almost all the time.” The second question was intended to determine the reasons clinicians do not regularly use scales to monitor outcome. Accordingly, only subjects who responded “never,” “rarely,” or “sometimes” to the first question were asked to respond to the second question. The second question was, “Please indicate why you do not routinely use rating scales to monitor the course of depression?” Response choices included “I do not believe it would be clinically helpful,” “I do not know what measure to use,” “It takes too much time,” “It is too disruptive of clinical practice,” “I was not trained to use them, and “other.” The response choices were based on conversations with psychiatrists about why they do not use scales in clinical practice.

Similar to the results of Gilbody and colleagues,10 Zimmerman and McGlinchey11 found that the vast majority of psychiatrists did not routinely use scales to monitor outcome when treating depression. Greater than 50% of psychiatrists indicated that they never (28.8%, n=88) or rarely (32.0%, n=98) used scales to monitor outcome, and <10% almost always (6.5%, n=20) used scales to monitor outcome of depression treatment.

The authors of this article compared the characteristics of psychiatrists who reported using scales frequently or almost always to the rest of the group. There were no differences between the two groups in gender, age, years of practice, or practice setting. Subjects who reported never, rarely, or only sometimes using scales to monitor outcome were asked the reasons for not routinely using scales in their clinical practice. More than 25% of the subjects indicated that they did not believe using scales would be clinically helpful, that they take too much time to use, and that they were not trained in their use (Table 1).

 

The results of these two surveys, one in the UK and one in the US, indicate that psychiatrists typically do not use standardized scales when treating patients with depression. One issue identified as an obstacle in their use is the perceived burden of scale completion. In the future, if the delivery of mental health treatment increasingly requires the measurement of outcome, then the user friendliness of measurement tools, as well as their reliability and validity, will be critical to their widespread adoption. Clinicians are already overburdened with paperwork, and adding to this load mandatory repeated detailed evaluations with such instruments as the HAM-D is unlikely to meet with success. Self-report questionnaires are a cost-effective option because they are inexpensive in terms of professional time needed for administration and correlate highly with clinician ratings. To be sure, there are also limitations with self-report questionnaires such as response set biases, and their use may be limited by the readability of the scale and literacy of the respondent. However, self-report scales are free of clinician bias and from clinician overestimation of patient improvement (which might occur when there are incentives to document treatment success).

 

Desirable Features of a Self-report Depression Outcome Scale

There is no shortage of measures to be used to monitor outcome. Two perspectives are of primary importance in deciding which measure to choose—that of the patient and the clinician. Patients should find the measure user-friendly and the directions easy to follow. The questions should be understandable and relevant to the patient’s problem. The scale should be brief, taking no more than 2–3 minutes to complete, so that upon routine administration at follow-up visits patients are not inconvenienced by the need to come for their appointment 10–15 minutes early in order to complete the measure. Brief scales can be feasibly completed at each follow-up visit in the same way that blood pressure and weight are routinely assessed in primary care settings for patients being treated for hypertension and obesity.

The instrument should provide clinicians with clinically useful information and improve the efficiency of conducting their clinical evaluation; thus, the measure should have practical value to the practicing clinician. Clinicians need to be able to trust the information provided by any instrument they use. Consequently, outcome measures for depression should have a sound basis in psychometrics, demonstrating good reliability, validity, and sensitivity to change. Clinicians and clinics should also find the instrument user-friendly; it should be easy to administer and score with minimal training.

During the past decade, the authors of this article have established and have been conducting the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project. One of the goals of the MIDAS project has been to develop instruments for use in routine clinical practice. The authors have developed a broad-based self-report scale for psychiatric screening12-14; a clinician-rated outcome measure for depression15; single-item self-report indices of depression symptom severity, psychosocial impairment and quality of life (QOL)16; and two different self-report depression scales.17,18 One of these scales, the Diagnostic Inventory for Depression (DID),18 was designed to assess the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition,19 symptom inclusion criteria for a major depressive episode, psychosocial impairment due to depression, and subjective QOL. However, with the respondent needing to read more than 100 statements, it may be too long to be feasible for use at every patient visit. On the DID, each symptom is assessed by groups of five statements arranged in order of increasing severity. Other scales that are constructed in a similar manner20-22 likewise are not conducive to routine clinical use because the relatively large number of statements that need to be read results in the measures taking more than 5 minutes to complete. More recently, the authors of this article developed a scale attending to the issue of clinical utility.17 The Clinically Useful Depression Outcome Scale (CUDOS) contains 18 items assessing all of the DSM-IV inclusion criteria for major depressive disorder (MDD) and dysthymic disorder as well as psychosocial impairment and QOL. The 16-symptom items are rated on a 5-point Likert scale in order to keep the scale brief. A copy of the scale is reproduced in the Figure.

 

 

 

Summary of Studies on the Reliability and Validity of the CUDOS

The CUDOS has undergone extensive testing of its psychometric properties and feasibility of use. Internal consistency reliability coefficients were computed separately for 1,475 patients who completed the scale at intake and 100 depressed patients who participated in an acceptance and feasibility study and completed it during a follow-up appointment.23 The CUDOS demonstrated excellent internal consistency in both samples (Cronbach’s alpha at intake=.90; Cronbach’s alpha at follow-up=.90). The test-retest reliability of the CUDOS was examined in 176 subjects at baseline and 33 subjects during follow-up. At both time points the test-retest reliability of the total scale was high (r=.92 and .95, respectively).

Discriminant and convergent validity was examined in 200 patients who completed a package of questionnaires at home an average of 1.2 days (SD=16.9) after the intake evaluation. The CUDOS was more highly correlated with the Beck Depression Inventory (BDI)20 (r=.81) than with measures of the other symptom domains such as posttraumatic stress disorder, alcohol use, and hypochondriasis (mean r=.35). Moreover, the CUDOS was almost as highly correlated with the HAM-D (r=.69) and the Clinical Global Index (CGI) of Depression Severity (r=.71),24 clinician ratings of the severity of depressive symptoms, as with the self-rated BDI. In a separate study of 267 patients evaluated during the course of outpatient treatment, the correlation between the CUDOS and HAM-D was .89.25

The CUDOS was able to discriminate between different levels of depression severity as rated on the CGI. The difference between each adjacent level of severity (eg, nondepressed versus minimally depressed and mild versus moderate) was significant. The data and clinical experience allowed the authors to derive empirically informed ranges of scores corresponding to a dimensional assessment of depression severity. The authors recommended that the nondepressed range corresponds to CUDOS scores of 0–10, minimal depression 11–20, mild depression 21–30, moderate depression 31–45, and severe depression ≥46.

Although the CUDOS was not primarily intended as a diagnostic measure, it performed well in this regard. Based on a Receiver Operating Curve analysis the area under the curve was .86. The sensitivity of the scale was 83.3%, specificity 72.1%, positive predictive value 72.6%, negative predictive value 82.9%, and chance-corrected agreement level k=.55.

The scale was sensitive to clinical change. Fifty-five depressed patients completed the CUDOS a second time 6 weeks after initiating antidepressants and were rated at baseline and 6 weeks on the Montgomery-Asberg Depression Rating Scale (MADRS). Not only was the change in CUDOS scores correlated with the change in MADRS values, but the CUDOS was able to distinguish between treatment remitters and responders. The patients were divided into three groups using the MADRS to determine remission and response status. Patients scoring ≤10 at week 6 were considered to be in remission (n=29); patients improving ≥50% on the MADRS but who scored >10 at week 6 were considered responders (n=7), and the remaining patients were considered nonresponders (n=19). Remitters scored significantly lower than responders, and responders scored significantly lower than nonresponders.

In the study of 267 depressed psychiatric outpatients in ongoing treatment, the authors examined the ability of the CUDOS to identify remission according to the HAM-D threshold of ≤7.25 At a cutoff of <20, the CUDOS had a sensitivity of 87.4%, specificity of 87.8%, overall agreement of 87.6%, and kappa of .75.

The results of these studies indicate that the CUDOS is a reliable and valid measure of depressive symptoms that is sensitive to clinical change and can be used to determine whether depressed patients have remitted from treatment. The next important question is the clinical utility of the measure.

 

Feasibility of Using the CUDOS in Clinical Practice

The feasibility and acceptability of incorporating the CUDOS into routine clinical practice was examined in two studies of depressed psychiatric outpatients who were in ongoing treatment.23 In the first study, the amount of time needed to complete the CUDOS during a follow-up appointment with a psychiatrist was recorded in a consecutive series of 50 depressed outpatients presenting at a follow-up visit. The patients also completed a questionnaire assessing how burdensome it was to complete the scale during the visit (0=very little burden; 3=a large burden), and their willingness to complete the scale at every visit to help monitor the progress of their treatment (0=not at all willing; 3=very willing to fill it out at every visit). All but two patients completed the scale in <3 minutes (mean=102.7 seconds; SD=42.7). Almost all patients considered questionnaire completion very little or a little burdensome (98.0%, n=49), and no patient perceived it as very burdensome. More than 90% of patients indicated a willingness to complete the CUDOS at every visit in the future if their clinician believed that it was helpful (94%, n=47).

In the second study of feasibility, a separate sample of 50 depressed outpatients completed both the CUDOS and the BDI during a follow-up visit. After completing the two questionnaires the patients completed a questionnaire asking which of the two measures took less time to complete, was easier to understand, was less burdensome to complete, and was more acceptable to complete at every follow-up appointment. Significantly more patients indicated that the CUDOS took less time to complete, and was less of a burden to complete (Table 2). Nearly three times as many patients indicated that they would prefer to complete the CUDOS than the BDI to monitor the outcome of treatment (40.0% vs. 14.0%, P<.05).

 

 

These studies suggest that patients did not find scale completion burdensome. However, the likelihood that clinicians will change their behavior and incorporate systematic measurement in their treatment of depressed patients will increase if there is also evidence of the therapeutic benefit of standardized outcome assessment.

 

Does Measurement Improve Outcome?

Lambert and colleagues26-28 have conducted a series of studies during the past 20 years on the impact of measurement and feedback on psychotherapy outcome. All patients completed a self-report outcome scale prior to every therapy appointment. After the first visit, a patient’s progress was compared to the expected course of symptomatic and functional improvement. The expected level of improvement was based on benchmarking studies of thousands of patients who received psychotherapy in diverse settings and who completed the same outcome measure. From these benchmarking studies, “recovery curves” were derived that graphically illustrated the expected rate and level of improvement. In the intervention studies examining the therapeutic benefit of measurement, patients were randomized to a feedback or no feedback condition. All patients completed the outcome scale before each therapy visit; a research assistant scored the scale and compared the results to the empirically derived recovery curves; and in the feedback condition, information was placed in the patient’s chart indicating the adequacy of improvement. Inadequate levels of improvement were accompanied by a message suggesting either that treatment should be intensified or perhaps changed altogether. In the no feedback condition the therapists did not receive information from the outcome assessment.

The results of the aforementioned studies26-28 have consistently demonstrated the therapeutic benefit of standardized assessment and feedback. Combining the results of the first two studies of >1,500 patients, the authors found that the improvement rate in patients failing to achieve expected improvement was significantly higher when clinicians received feedback regarding patients’ relatively poor progress than in patients in the no feedback condition (30.5% versus 17.5%). Moreover, they found that among patients who were not responding to treatment, those who were randomized to the feedback condition received significantly more therapy visits than the patients randomized to the no feedback condition.

These studies have found that measurement and feedback was associated with improved outcome, and can influence therapists’ behavior insofar as more therapy visits were conducted with clients who were not doing as well as expected. To be sure, there are some limitations to this research program. All of these studies have been conducted with mildly ill clients receiving psychotherapy at a university counseling center. In addition, the measurement system was complex and relied on research assistants to score the measure and alert clinicians to the results. Such an approach is cost prohibitive for implementation in real-world clinical practice. As Lambert and colleagues27 themselves noted in the conclusion of their first replication study, “if client-focused outcome research is to have any applicability it must remain simple and easy to implement in day-to-day clinical practice.” Nonetheless, the results provide some empirical evidence of the therapeutic benefit of monitoring outcome.

 

Are You Using Scales to Monitor Outcome When Treating Depressed Patients?

The community standard of care for treating depression does not include routine use of reliable and valid scales to monitor outcome. The authors of this article believe that this is an inadequate and indefensible state of current practice. Would a physician treat diabetes without measuring glucose levels? Would he or she treat hypertension without measuring blood pressure or a febrile illness without measuring body temperature? Of course not; the same should be true of the treatment of depression.

The authors believe that systematic outcome assessment will assume increasing importance during the next decade, if for no other reason that payor mandates will require it. The Centers for Medicare and Medicaid Services’ Physician Quality Reporting Initiative (PQRI),29 signed into law in 2006, is intended to improve quality of care by providing physicians financial incentives to document outcomes reflecting best practices. In 2007, the first year of the PQRI, 74 indicators were listed, one of which was related to the treatment of depression (percentage of patients ≥18 years of age diagnosed with new episode of MDD and documented as treated with antidepressant medication during the entire 84-day [12-week] acute treatment phase). In 2008, the PQRI list of indicators was expanded to 134 items, with two additional indicators related to the treatment of depression (percentage of patients aged ≥18 years of age with a new diagnosis or recurrent episode of MDD who met the DSM-IV criteria during the visit in which the new diagnosis or recurrent episode was identified; percentage of patients ≥18 years of age with a new diagnosis or recurrent episode of MDD who had a suicide risk assessment completed at each visit). While the current PQRI indicators related to depression have only referred to the adequacy of assessment and treatment duration, a future version of the PQRI list of indicators may include a determination of the effectiveness of treatment. This will require clinicians to measure outcome using a reliable and valid measurement tool. The two surveys of current clinical practice by Gilbody and colleagues.10 and Zimmerman and McGlinchey11 suggest that educational efforts will probably be required to acquaint psychiatrists, as well as other healthcare professionals, with reliable, valid measures that are feasible to incorporate into clinical practice.

Recently, the term “measurement-based care” has been coined in reference to the use of standardized scales to measure the outcome of psychiatric treatment. Suggestions of the beneficial impact of measuring outcome come from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, the largest study of the treatment of depression ever conducted. In the acute phase component of STAR*D, during which patients were treated with citalopram for up to 12 weeks, the rates of response and remission were similar to the rates typically reported in controlled efficacy studies. Trivedi and colleagues30 suggested that an adequate treatment response might have been more difficult to achieve in STAR*D than typical industry-funded efficacy studies because patients with comorbid disorders, who are less responsive to treatment, were not excluded. They attributed the better than expected (albeit modest) response and remission rates to the adoption of a system of measurement-based care. That is, they suggested that the use of frequent, standardized, quantitative assessments to guide treatment decision-making contributed to an increased likelihood of a positive outcome, and they recommended that a measurement-based care approach toward clinical management be adopted in routine clinical practice. If measurement-based care is to be incorporated into clinical practice it will be important to keep the burden of that assessment to a minimum.

 

Conclusion

A consumer-friendly reliable and valid self-administered questionnaire can improve the efficiency of the clinical encounter, and allow clinicians to spend more time discussing topics other than symptoms. In this era when many clinical encounters are 15-minute (or briefer) medication visits, increased efficiency can make the visit more meaningful and beneficial to both clinicians and patients. The brevity of the CUDOS lends itself to regular administration in clinical practice. Although brief, it covers the full range of DSM-IV criteria and thus provides clinically useful information.

There may be only limited data suggesting that measurement might improve outcome when treating depression, but there is no reason to wait until the studies have been conducted to prove the benefit of measurement-based care in the treatment of depression. There is little downside to adopting this approach when treating depressed patients.

There are many self-administered depression scales, though some are less appealing as outcome tools for use in routine clinical practice because they are either too long,20-22 lack adequate coverage of the DSM-IV criteria,31,32 are expensive to purchase,19 or are somewhat complicated to score.31 Because of ease of use considerations, the authors recommend that either the CUDOS or the 9-item Patient Health Questionnaire (PHQ-9)33 be used by clinicians at every visit to monitor the course of depression. In fact, because it contains fewer items than the CUDOS, the PHQ-9 probably takes even less time to complete. However, the advantage offered by being somewhat briefer is offset by some loss of information. The PHQ-9 adheres to the construction of the DSM-IV criteria; thus, compound DSM-IV criteria that refer to more than one symptom (eg, insomnia or hypersomnia, increased or decreased appetite) are represented by a single item on the PHQ-9. Since treatment decision making might be influenced by whether a patient has insomnia or sleeps too much, or has a reduced appetite or eats too much, the PHQ-9 does not capture potentially clinically significant information. However, more important than which scale is used to monitor outcome is that some measure is used. Measures such as the CUDOS or PHQ-9 have clearly identified cutoff scores to identify remission and should not require any special training to be adopted by non-mental health professionals.

Upon reading this article, many clinicians are likely to persist in not using standardized scales to measure outcome when treating depression. The authors of this article hope to hear from clinicians as to why they have not changed their behavior. Please send us an e-mail. As mental health professionals, the authors are well aware of the difficulty of getting individuals to change their behavior. Attempts to get patients to change behavior is not limited to mental health professionals. Readers who do not adopt a measurement-based approach toward treating depression should reflect on their reasons for not changing their behavior the next time they feel frustrated with a patient who does not follow their valid and appropriate treatment recommendations. PP

 

References

1.    Paykel ES, Ramana R, Cooper Z, Hayhurst H, Kerr J, Barocka A. Residual symptoms after partial remission: An important outcome in depression. Psychol Med. 1995;25(6):1171-1180.
2.    Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23(1):56-62.
3.    Evans M, Hollon S, DeRubeis R, et al. Differential relapse following cognitive therapy and pharmacotherapy for depression. Arch Gen Psychiatry. 1992;49(10):802-808.
4.    Faravelli C, Ambonetti A, Pallanti S, Pazzagli A. Depressive relapses and incomplete recovery from index episode. Am J Psychiatry. 1986;143(7):888-891.
5.    Judd L, Paulus M, Schettler P, et al. Does incomplete recovery from first lifetime major depressive episode herald a chronic course of illness? Am J Psychiatry. 2000;157:(9)1501-1504.
6.    Pintor L, Gasto C, Navarro V, Torres X, Fananas L. Relapse of major depression after complete and partial remission during a 2-year follow-up. J Affect Disord. 2003;73(3):237-244.
7.    Simons A, Murphy G, Levine J, Wetzel R. Cognitive therapy and pharmacotherapy for depression. Sustained improvement over one year. Arch Gen Psychiatry. 1986;43(1):43-48.
8.    Thase ME, Simons AD, McGeary J, et al. Relapse after cognitive behavior therapy of depression: potential implications for longer courses of treatment. Am J Psychiatry. 1992;149:(8)1046-1052.
9.    Van London L, Molenaar RP, Goekoop JG, Zwinderman AH, Rooijmans HGM. Three- to 5-year prospective follow-up of outcome in major depression. Psychol Med. 1998;28(3):731-735.
10.    Gilbody S, House A, Sheldon T. Psychiatrists in the UK do not use outcomes measures. National survey. Br J Psychiatry. 2002;180(2):101-103.
11.    Zimmerman M, McGlinchey JB. Why don’t psychiatrists use scales to measure outcome when treating depressed patients? J Clin Psychiatry. In press.
12.    Zimmerman M, Mattia JI. The Psychiatric Diagnostic Screening Questionnaire: development, reliability and validity. Compr Psychiatry. 2001;42:(3)175-189.
13.    Zimmerman M, Mattia JI. A self-report scale to help make psychiatric diagnoses: the Psychiatric Diagnostic Screening Questionnaire (PDSQ). Arch Gen Psychiatry. 2001;58(8):787-794.
14.    Zimmerman M, Chelminski I. A scale to screen for axis I disorders in psychiatric outpatients: performance of the Psychiatric Diagnostic Screening Questionnaire. Psychol Med. 2006;36(11):1601-1611.
15.    Zimmerman M, Posternak M, Friedman M, Chelminski I. A standardized clinical outcome rating scale for depression for use in clinical practice. Depress Anxiety. 2005;22(1):36-40.
16.    Zimmerman M, Ruggero CJ, Chelminski I, et al. Developing brief scales for use in clinical practice: the reliability and validity of single-item self-report measures of depression symptom severity, psychosocial impairment due to depression, and quality of life. J Clin Psychiatry. 2006;67(10):1536-1541.
17.    Zimmerman M, Chelminski I, McGlinchey JB, Posternak MA. A clinically useful depression outcome scale. Compr Psychiatry. 2008;49(2):131-140.
18.    Zimmerman M, Sheeran T, Young D. The Diagnostic Inventory for Depression: a self-report scale to diagnose DSM-IV for major depressive disorder. J Clin Psychol. 2004;60(1):87-110.
19.    Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association; 1994.
20.    Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry. 1961;4:561-571.
21.    Rush AJ, Gullion CM, Basco MR, Jarrett RB, Trivedi MH. The Inventory of Depressive Symptomatology (IDS). Psychol Med. 1996;26(3):477-486.
22.    Zimmerman M, Coryell W, Corenthal C, Wilson S. A self-report scale to diagnose major depression disorder. Arch Gen Psychiatry. 1986;43(11):1076-1081.
23.    Zimmerman M, McGlinchey J. Depressed patients’ acceptability of the use of self-administered scales to measure outcome in clinical practice. Ann Clin Psychiatry. In press.
24.    Guy W. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: National Institute of Mental Health; 1976.
25.    Zimmerman M, Posternak M, Chelminski I. Using a self-report depression scale to identify remission in depressed outpatients. Am J Psychiatry. 2004;161(10):1911-1913.
26.    Lambert MJ, Whipple JL, Smart DW, Vermeersch DA, Nielsen SL, Hawkins EJ. The effects of providing therapists with feedback on patient progress during psychotherapy: are outcomes enhanced? Psychother Res. 2001;11(1):49-68.
27.    Lambert MJ, Whipple JL, Vermeersch DA, et al. Enhancing psychotherapy outcomes via providing feedback on client progress: a replication. Clin Psychol Psychother. 2002;9(2):91-103.
28.    Lambert MJ, Hansen NB, Finch AE. Patient-focused research: using patient outcome data to enhance treatment effects. J Consult Clin Psychol. 2001;69(2):159-172.
29.    US Department of Health and Human Services. Physician Quality Reporting Initiative. Center for Medicare and Medicaid Services. Available at: www.cms.hhs.gov/PQRI/30_EducationalResources.asp. Accessed April 23, 2008.
30.    Trivedi M, Rush A, Wisniewski S, et al. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D implications for clinical practice. Am J Psychiatry. 2006;163(1):28-40.
31.    Zung WWK. A self-rating depression scale. Arch Gen Psychiatry. 1965;12(1):63-70.
32.    Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Appl Psych Meas. 1977;1(3):385-401.
33.    Kroenke K, Spitzer R, Williams J. The PHQ-9. Validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606-613.