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| Sponsor: | Brigham and Women's Hospital |
|---|---|
| Collaborator: |
National Institute of Mental Health (NIMH) |
| Information provided by (Responsible Party): | Arthur Joseph Barsky III,M.D., Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00368212 |
Purpose
This study will evaluate the effectiveness of an integrated three-part treatment program in improving the quality of care and treatment outcomes of people with hypochondriasis in primary care settings.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypochondriasis Somatoform Disorders |
Behavioral: Relaxation response training Behavioral: Psychoeducational counseling |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treating Refractory Symptoms in Primary Care (Hypochondriasis: Diagnosis, Description and Medical Care) |
| Estimated Enrollment: | 320 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive psychoeducational counseling (termed "health care counseling")
|
Behavioral: Psychoeducational counseling
Patients will receive five sessions of psychoeducational counseling from the nurse who works with the primary care physicians. Patients who are interested in continuing treatment or who have not responded to this first treatment step will then be referred for the second step, cognitive behavioral therapy (CBT), for more intensive treatment.
Other Name: Educational Counseling
|
|
Active Comparator: 2
Participants will receive relaxation response training
|
Behavioral: Relaxation response training
The control treatment is relaxation training or attention control. This will be taught in three, 1-hour sessions with a trained therapist.
Other Name: Relaxation and Stress Reduction
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Hypochondriasis, which is classified as a type of somatoform disorder, is one of the most difficult psychiatric disorders to treat. It is prevalent in primary care settings, and is a major source of suffering for patients and frustration for physicians. People with hypochondriasis tend to become preoccupied with the fear of having a serious disease, despite appropriate medical evaluations and reassurance that indicate otherwise. The disorder usually occurs in episodes lasting from months to years, separated by equally long periods of quiescence. Existing strategies for treating hypochondriasis include psychotherapy, medication treatment, and alternative treatments, such as exercise and electroconvulsive therapy. An effective treatment program should target the needs of both patients and physicians, as well as the structure of the delivery system. Components of such a program have been developed, but have not yet been integrated and tested in a clinical setting. This study will evaluate the effectiveness of an integrated three-part treatment program in improving hypochondriasis treatment and quality of care outcome in primary care settings.
Participants in this 6-month, single-blind study will first undergo baseline assessments. They will then be randomly assigned to partake in either the three-part treatment program or relaxation response training, in which patients are taught to use muscle relaxation techniques to reduce stress. Over the course of the study, participants assigned to the three-part program will attend five self-scheduled, 30-minute sessions of psychoeducational counseling based on cognitive behavioral therapy principles. Sessions will focus on common hypochondriacal cognitive distortions and misunderstandings about symptoms, disease, and medical care. Additionally, the doctors and nurses at the participating hospital will undergo a training program to improve medical management of patients with hypochondriasis. The final component of the program will entail implementing an enhanced role for nurse practitioners to collaborate with primary care physicians in caring for patients with hypochondriasis. Participants assigned to relaxation response training will attend three self-scheduled, 1-hour sessions over the course of the study. They will be provided with an explanation of the physical effects of stress on the body and the purposes of progressive muscle relaxation training. They will then learn a relaxation technique through direct instruction, and will practice between sessions. Participants will also use a 20-minute audio tape to practice once a day, 5 to 7 days a week between clinic visits. All participants will attend self-scheduled follow-up visits 6 and 12 months following the end of treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Harvard Vanguard Medical Associates | |
| Boston, Massachusetts, United States, 02472 | |
| Harvard Vanguard Medical Associates | |
| Cambridge, Massachusetts, United States, 02138 | |
| Principal Investigator: | Arthrur J. Barsky, MD | Brigham and Women's Hospital |
More Information
| Responsible Party: | Arthur Joseph Barsky III,M.D., principal investigator, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00368212 History of Changes |
| Other Study ID Numbers: | R01 MH040487, R01MH040487, DSIR 82-SEPC |
| Study First Received: | August 23, 2006 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Federal Government |
|
Somatization Refractory Symptoms |
|
Hypochondriasis Somatoform Disorders Mental Disorders |