Comparing Cognitive Behavioral Therapy, Antidepressant Medication, &

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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 weeks, then biweekly until Week 12, and then monthly until week 24. Outcomes will be assessed at study visits at Weeks 6, 12, 24, and 48, and over the phone at Week 36. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Hypochondriasis

Clinical Trial Details

NCT number	NCT00339079
Study type	Interventional
Source	Brigham and Women's Hospital
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	June 2006
Completion date	December 2011

View Details

See also
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Completed	`NCT02131883` - Outcome of Cognitive Behavioral Therapy for Patients With Severe Health Anxiety Treated in Group Only. A RCT.	N/A
Completed	`NCT00208247` - KATHY:Cognitive-behavioural Therapy for Hypochondriasis	Phase 2
Not yet recruiting	`NCT05942391` - Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders	N/A
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Completed	`NCT04921280` - Effectiveness of ICBT for Severe Health Anxiety in Clinical Psychiatry.
Not yet recruiting	`NCT03024593` - An Examination of the Effects of Health-related Internet Use in Individuals With Pathological Health Anxiety	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparing Cognitive Behavioral Therapy, Antidepressant Medication, and Combined Treatment in Individuals With Hypochondriasis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms