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Integrated Treatment Program for Hypochondriasis in Primary Care Settings

Primary Purpose

Hypochondriasis, Somatoform Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Relaxation response training
Psychoeducational counseling
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypochondriasis focused on measuring Somatization, Refractory Symptoms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harvard Vanguard Medical Associates
  • Harvard Vanguard Medical Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive psychoeducational counseling (termed "health care counseling")

Participants will receive relaxation response training

Outcomes

Primary Outcome Measures

Whitely Index

Secondary Outcome Measures

Health Anxiety Inventory
Modified Cognitions Questionnaire
Somatic Symptom Inventory
Functional Status Questionnaire
Client Satisfaction Index

Full Information

First Posted
August 23, 2006
Last Updated
March 15, 2013
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00368212
Brief Title
Integrated Treatment Program for Hypochondriasis in Primary Care Settings
Official Title
Treating Refractory Symptoms in Primary Care (Hypochondriasis: Diagnosis, Description and Medical Care)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypochondriasis, Somatoform Disorders
Keywords
Somatization, Refractory Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive psychoeducational counseling (termed "health care counseling")
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive relaxation response training
Intervention Type
Behavioral
Intervention Name(s)
Relaxation response training
Other Intervention Name(s)
Relaxation and Stress Reduction
Intervention Description
The control treatment is relaxation training or attention control. This will be taught in three, 1-hour sessions with a trained therapist.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational counseling
Other Intervention Name(s)
Educational Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Whitely Index
Time Frame
Measured immediately post-treatment and at Months 6 and 12 post-treatment
Secondary Outcome Measure Information:
Title
Health Anxiety Inventory
Time Frame
Measured immediately post-treatment and at Months 6 and 12 post-treatment
Title
Modified Cognitions Questionnaire
Time Frame
Measured immediately post-treatment and at Months 6 and 12 post-treatment
Title
Somatic Symptom Inventory
Time Frame
Measured immediately post-treatment and at Months 6 and 12 post-treatment
Title
Functional Status Questionnaire
Time Frame
Measured immediately post-treatment and at Months 6 and 12 post-treatment
Title
Client Satisfaction Index
Time Frame
Measured immediately post-treatment and at Months 6 and 12 post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthrur J. Barsky, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard Vanguard Medical Associates
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Harvard Vanguard Medical Associates
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23494213
Citation
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.
Results Reference
derived

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Integrated Treatment Program for Hypochondriasis in Primary Care Settings

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