Status:
COMPLETED
Treatment of Hypochondriasis With CBT and/or SSRI
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Hypochondriasis
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study will compare the effectiveness of cognitive behavioral therapy, antidepressant medication, and a combination of the two for treating hypochondriasis.
Detailed 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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Meets DSM-IV criteria for hypochondriasis; ascertained by Structured Diagnosis for Hypochondriasis module of SCID-I, and meets a hypochondriasis severity rating of at least "moderate".
- Drug free for 6 weeks of all psychoactive or investigational medications (seven weeks for fluoxetine).
- Approval from treating physician if concomitant psychoactive medications need to be withdrawn prior to study participation.
- English fluency and literacy.
- Exclusion Criteria
- Pregnant or nursing mothers and women of childbearing potential who are not taking adequate birth control precautions.
- Any of the following Axis I mental disorders: chronic pain syndrome, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, alcohol abuse or dependence disorder (current or within the last six months), or substance abuse or dependence disorder (current or within the last twelve months). Patients with other comorbid psychiatric disorders are eligible based on the following three criteria: hypochondriasis must be the predominant presenting disorder; patient can not have a major co-morbid psychiatric disorder rated as "severe" on the Clinical Global Impressions Scale (CGI Scale); and patients can not have a co-morbid psychiatric disorder that causes significant functional impairment (significant functional impairment will be defined as an impairment that interferes in a marked way with expected role functioning, vocational and/or interpersonal).
- Suicidality within the last 6 months as established by a score of 9 or more on the suicidality module of the MINI Plus.
- Symptom-contingent pending litigation, disability compensation, or workers' compensation proceedings
- Major medical illness expected to worsen significantly, lead to hospitalization, or likely to prove fatal in the next six months, established with the Cumulative Illness Rating Scale (CIRS); Stable, chronic medical illness is not an exclusion criterion
- Not able to withdraw from concomitant psychoactive medications or currently taking necessary other medication that might interact adversely with fluoxetine:
- Clinically important abnormalities in ECG, laboratory tests (including thyroid function) or physical examination. "Clinically important" abnormalities are those that signify a treatment intervention is needed or a medical abnormality has not been sufficiently addressed. Patients with medical problems that are stable and chronic are eligible, but patients with medical problems that are unstable, acute, or inadequately evaluated will be excluded. A current electrocardiogram is required for all patients with symptoms suggestive of cardiac disease, including chest pain, dyspnea, palpitations, or lightheadedness; if no current electrocardiogram exists, the study will obtain one.
- History of severe side effects associated with fluoxetine or noncompliance with prior CBT for hypochondriasis
- Previous adequate trial of either fluoxetine (eight weeks of which two weeks were at a minimum dose of 60 mg/day) or CBT for hypochondriasis (at least four sessions specifically targeting hypochondriacal symptoms) will be excluded, regardless of prior response. Inability to ambulate or mobility restrictions that prohibit frequent travel to the hospital for treatment and evaluation.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00339079
Start Date
June 1 2006
End Date
December 1 2011
Last Update
April 25 2017
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Columbia Medical Center, New York Psychiatric Institute
New York, New York, United States, 10032