NCT00368212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2005

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

3.2 years

First QC Date

August 23, 2006

Last Update Submit

March 15, 2013

Conditions

HypochondriasisSomatoform Disorders

Keywords

SomatizationRefractory Symptoms

Outcome Measures

Primary Outcomes (1)

  • Whitely Index

    Measured immediately post-treatment and at Months 6 and 12 post-treatment

Secondary Outcomes (5)

  • 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

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Psychoeducational counseling

2

ACTIVE COMPARATOR

Participants will receive relaxation response training

Behavioral: Relaxation response training

Interventions

Relaxation response trainingBEHAVIORAL

The control treatment is relaxation training or attention control. This will be taught in three, 1-hour sessions with a trained therapist.

Also known as: Relaxation and Stress Reduction
2
Psychoeducational counselingBEHAVIORAL

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.

Also known as: Educational Counseling
1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harvard Vanguard Medical Associates

Boston, Massachusetts, 02472, United States

Location

Harvard Vanguard Medical Associates

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (1)

  • 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.

    PMID: 23494213DERIVED

MeSH Terms

Conditions

HypochondriasisSomatoform Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Arthrur J. Barsky, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 23, 2006

First Posted

August 24, 2006

Study Start

May 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

US(2)