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Integrated Treatment Program for Hypochondriasis in Primary Care Settings
This study is ongoing, but not recruiting participants.
Study NCT00368212   Information provided by National Institute of Mental Health (NIMH)
First Received: August 23, 2006   Last Updated: March 23, 2009   History of Changes

August 23, 2006
March 23, 2009
May 2005
June 2009   (final data collection date for primary outcome measure)
Whitely Index [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment ] [ Designated as safety issue: No ]
Whitely Index (measured immediately post-treatment and at Months 6 and 12 post-treatment)
Complete list of historical versions of study NCT00368212 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Health Anxiety Inventory
  • Modified Cognitions Questionnaire
  • Somatic Symptom Inventory
  • Functional Status Questionnaire
  • Client Satisfaction Index (all measured immediately post-treatment and at Months 6 and 12 post-treatment)
 
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.

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.

Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Hypochondriasis
  • Somatoform Disorders
  • Behavioral: Relaxation response training
  • Behavioral: Psychoeducational counseling
  • Experimental: Participants will receive psychoeducational counseling (termed "health care counseling")
  • Active Comparator: Participants will receive relaxation response training
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
320
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00368212
Arthur J. Barsky, MD, Director of Psychiatric Research, Brigham and Women's Hospital
R01 MH040487, DSIR 82-SEPC
National Institute of Mental Health (NIMH)
 
Principal Investigator: Arthrur J. Barsky, MD Brigham and Women's Hospital
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP