Clinical Trial: Treatment of Hypochondriasis With CBT and/or SSRI

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Hypochondriasis With CBT and/or SSRI

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

Detailed Summary:

Hypochondriasis is one of the most difficult psychiatric disorders to treat. People with hypochondriasis believe that real or imagined physical symptoms are signs of serious illnesses, despite medical reassurance and other evidence to the contrary. Symptoms of the disorder include a preoccupation with fear of an illness; a persistent fear of having a serious illness, despite medical reassurance; and misinterpretation of symptoms. Some individuals with hypochondriasis recognize that their fear of having a serious illness may be excessive, unreasonable, or unfounded. Episodes of hypochondriasis usually last from months to years, with equally long periods of remission. Cognitive behavioral therapy (CBT) and the antidepressant drug fluoxetine (FLX) have both been shown to be effective treatments for hypochondriasis. However, the relative efficacy of a combined approach has yet to be determined. This study will compare the effectiveness of cognitive behavioral therapy, antidepressant medication, and a combination of the two for treating hypochondriasis.

Participants in this double-blind study will first report to the study site for two sessions to determine eligibility for participation. Eligible individuals will then be randomly assigned to receive one of the following four treatments for 12 weeks: CBT only; FLX only; CBT plus FLX; or a placebo pill. All participants receiving medication will also receive supportive therapy. Treatment response will be assessed at Week 12, and participants who have shown improvement will continue in the study for an additional 12 weeks. Participants who have not responded to treatment will be removed from the study and will receive open treatment. Participants assigned to receive medication or placebo will take medication once daily for the full 24 weeks. Participants assigned to CBT only or CBT plus FLX will receive CBT weekly for the first 8
Sponsor: Brigham and Women's Hospital

Current Primary Outcome: 25% Improvement on Both Whiteley Index and H-YBOCS-M [ Time Frame: Measured at Week 24 ]

Whitley index is a self-report measure of hypochondriasis H-YBOCS-M is an independent evaluator structured assessment of hypochondriasis


Original Primary Outcome:

  • Measured at Weeks 24, 36, and 48: Clinical Global Impressions Scale
  • Columbia Heightened Illness Concern - Obsessive-Compulsive Scale


Current Secondary Outcome: Columbia Heightened Illness Concern - Obsessive-Compulsive Scale [ Time Frame: Not measured ]

The Columbia Heightened Illness Concern - Obsessive-Compulsive Scale was the name for an earlier version of the H-YBOCS-M. The H-YBOCS-M is an expanded version and has additional items not included in the Columbia Heightened Illness Concern OCS. We did not administer the CHIC-OCS to patients in this study.


Original Secondary Outcome:

  • Measured at Weeks 24, 36, and 48: Heightened Illness Concern Severity Scale
  • Whiteley Index
  • State-Trait Anxiety Inventory
  • Beck-II Depression Inventory


Information By: Brigham and Women's Hospital

Dates:
Date Received: June 16, 2006
Date Started: June 2006
Date Completion:
Last Updated: March 24, 2017
Last Verified: March 2017