Integrated Treatment Program for Hypochondriasis in Primary Care Settings

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Arthur Joseph Barsky III,M.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00368212
First received: August 23, 2006
Last updated: March 15, 2013
Last verified: March 2013
  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 3

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)

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Whitely Index [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health Anxiety Inventory [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ] [ Designated as safety issue: No ]
  • Modified Cognitions Questionnaire [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ] [ Designated as safety issue: No ]
  • Somatic Symptom Inventory [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ] [ Designated as safety issue: No ]
  • Functional Status Questionnaire [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ] [ Designated as safety issue: No ]
  • Client Satisfaction Index [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: May 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368212

Locations
United States, Massachusetts
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States, 02472
Harvard Vanguard Medical Associates
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Arthrur J. Barsky, MD Brigham and Women's Hospital
  More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: March 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
Somatization
Refractory Symptoms

Additional relevant MeSH terms:
Somatoform Disorders
Hypochondriasis
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014