Integrated Treatment Program for Hypochondriasis in Primary Care Settings

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

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.

Study Overview

• Status: Completed
• Conditions: Somatoform Disorders; Hypochondriasis
• Intervention / Treatment: Behavioral: Psychoeducational counseling; Behavioral: Relaxation response training

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02472
      • Harvard Vanguard Medical Associates
    • Cambridge, Massachusetts, United States, 02138
      • Harvard Vanguard Medical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Relaxation and Stress Reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Whitely Index	Measured immediately post-treatment and at Months 6 and 12 post-treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Health Anxiety Inventory	Measured immediately post-treatment and at Months 6 and 12 post-treatment
Modified Cognitions Questionnaire	Measured immediately post-treatment and at Months 6 and 12 post-treatment
Somatic Symptom Inventory	Measured immediately post-treatment and at Months 6 and 12 post-treatment
Functional Status Questionnaire	Measured immediately post-treatment and at Months 6 and 12 post-treatment
Client Satisfaction Index	Measured immediately post-treatment and at Months 6 and 12 post-treatment

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Arthrur J. Barsky, MD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• Barsky AJ, Ahern DK, Bauer MR, Nolido N, Orav EJ. A randomized trial of treatments for high-utilizing somatizing patients. J Gen Intern Med. 2013 Nov;28(11):1396-404. doi: 10.1007/s11606-013-2392-6. Epub 2013 Mar 14.

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: August 23, 2006
• First Submitted That Met QC Criteria: August 23, 2006
• First Posted (Estimate): August 24, 2006

Study Record Updates

• Last Update Posted (Estimate): March 19, 2013
• Last Update Submitted That Met QC Criteria: March 15, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Somatization; Refractory Symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Somatoform Disorders; Hypochondriasis
• Other Study ID Numbers: R01MH040487 (U.S. NIH Grant/Contract); DSIR 82-SEPC