Integrated Treatment Program for Hypochondriasis in Primary Care Settings

Somatoform Disorders Clinical Trial

Official title:

Treating Refractory Symptoms in Primary Care (Hypochondriasis: Diagnosis, Description and Medical Care)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368212
• Other study ID #: R01MH040487
• Secondary ID: R01MH040487DSIR
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2006
• Last updated: March 15, 2013
• Start date: May 2005
• Est. completion date: July 2008

Study information

• Verified date: March 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Has received primary medical care at Harvard Vanguard Medical Associates (HVMA) for at least 12 months prior to study entry

• Expects to continue receiving care from the current primary care physician for at least the next 12 months

• Meets requirement for average hypochondriasis screening score

• Able to speak and read English

• Falls within the top 20% of utilizers of health care services in the HVMA system over the past year

• Has attended no more than one visit to any specialist over the year prior to study entry

Exclusion Criteria:

• Psychiatric illness (e.g., psychosis, dementia, suicidal ideation)

• Somatoform pain disorder or currently receiving treatment for somatoform pain disorder (e.g., relaxation training)

• History of alcohol or substance abuse or dependence within the 12 months prior to study entry

• Terminal medical illness or major medical illness expected to worsen significantly over the next year

• Ongoing symptom-contingent litigation against HVMA

• Monetary compensation for medical disability

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypochondriasis
• Somatoform Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Harvard Vanguard Medical Associates	Boston	Massachusetts
United States	Harvard Vanguard Medical Associates	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whitely Index		Measured immediately post-treatment and at Months 6 and 12 post-treatment	No
Secondary	Health Anxiety Inventory		Measured immediately post-treatment and at Months 6 and 12 post-treatment	No
Secondary	Modified Cognitions Questionnaire		Measured immediately post-treatment and at Months 6 and 12 post-treatment	No
Secondary	Somatic Symptom Inventory		Measured immediately post-treatment and at Months 6 and 12 post-treatment	No
Secondary	Functional Status Questionnaire		Measured immediately post-treatment and at Months 6 and 12 post-treatment	No
Secondary	Client Satisfaction Index		Measured immediately post-treatment and at Months 6 and 12 post-treatment	No