Integrated Treatment Program for Hypochondriasis in Primary Care Settings
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|ClinicalTrials.gov Identifier: NCT00368212|
Recruitment Status : Completed
First Posted : August 24, 2006
Last Update Posted : March 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypochondriasis Somatoform Disorders||Behavioral: Relaxation response training Behavioral: Psychoeducational counseling||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treating Refractory Symptoms in Primary Care (Hypochondriasis: Diagnosis, Description and Medical Care)|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
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
- Whitely Index [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ]
- Health Anxiety Inventory [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ]
- Modified Cognitions Questionnaire [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ]
- Somatic Symptom Inventory [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ]
- Functional Status Questionnaire [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ]
- Client Satisfaction Index [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368212
|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|