Treatment of Hypochondriasis With CBT and/or SSRI

Summary

This study will compare the effectiveness of cognitive behavioral therapy, antidepressant medication, and a combination of the two for treating hypochondriasis.

Conditions

• Hypochondriasis

Interventions

DRUG

Fluoxetine

Each patient will receive fluoxetine in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter. The maximum dose for patients who are age 60 or older will be 60 mg/day. The study psychiatrist will have the option of not increasing or lowering the dose if hypochondriacal symptoms have resolved nearly completely for the last two weeks or adverse effects thought to be due to fluoxetine have occurred.

BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes will be conducted at Weeks 8 and 12. The introduction of boosters will make the CBT alone and medication alone arms identical in length.

OTHER

Supportive Therapy

The supportive therapy component of the treatment is similar to what might occur in a family physician's office. Participants will meet with the same psychiatrist throughout the study, who will offer general encouragement; review the participant's illness, physical symptoms and, adverse effects over the previous week; and monitor medication dosage accordingly. Patients will be seen at Weeks 1, 2, 3, 4, 6, 8, 10, and 12, for medication adjustment. Visits with the psychiatrist will last 30 minutes.

DRUG

Placebo

Each patient will receive placebo in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Arthur J. Barsky, MD · Brigham and Women's Hospital and Harvard Medical School

• Brian Fallon, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-06-30

Primary Completion

2011-05-31

Completion

2011-12-31

Countries

• United States

Study Locations