CBT as an Adjunct to SRIs in the Treatment of BDD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Mount Sinai School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00211809
First received: September 13, 2005
Last updated: May 23, 2008
Last verified: May 2008
  Purpose

The research project is a controlled pilot study of the efficacy of cognitive-behavioral therapy (CBT) as an adjunct to serotonin reuptake inhibitor (SRI) pharmacotherapy in body dysmorphic disorder (BDD). This study assesses the efficacy of CBT in comparison to relaxation and stress management training (RSMT), an active control treatment


Condition Intervention Phase
Body Dysmorphic Disorder
Behavioral: Cognitive Behavioral Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Controlled Trial of Cognitive-Behavioral Therapy as an Adjunct to Serotonin Reuptake Inhibitors in Body Dysmorphic Disorder

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Body Dysmorphic Disorder
  • Yale Brown Obsessive Scale
  • Body Dysmorphic Disorder Clinical Global Impressions Scale

Secondary Outcome Measures:
  • Brown Assessment of Beliefs Scale
  • Beck Depression Inventory II
  • Beck Anxiety Inventory

Estimated Enrollment: 80
Detailed Description:

In total, 20 BDD patients aged 16 through 65 will participate. To be eligible they must meet DSM-IV criteria for BDD, have a score of 20 or greater on the BDD modification of the Yale Brown Obsessive-Compulsive Scale (BDD-YBOCS) and be on a stable, therapeutic does of an SRI (at least 12 weeks on the SRI with 8 weeks at a therapeutic dose: acceptable medications (therapeutic daily doses) are citalopram (40mg), clomipramine (150mg), fluoxetine (40mg), fluvoxamine (150mg), paroxetine (40mg), sertraline (50mg), and venlafaxine (150mg).

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria:

  • Study exclusion criteria include: current or lifetime diagnosis of any DSM_IV psychotic disorder not attributable to delusional BDD, current or lifetime diagnosis of DSM-IV bipolar disorder, current or recent (within 2 months of study entry) DSM-IV alcohol or substance dependence or abuse, recent suicide attempt, or suicidal ideation that warrants consideration of hospitalization, need for inpatient or partial hospital treatment, use of any medication prescribed for the treatment of BDD other than SRIs, including tricyclic antidepressants, buspirone, or neuroleptics, presence of any significant and/or unstable medical condition, females who are pregnant or breast-feeding, or who are sexually active and not using adequate contraception.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00211809

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Eric Hollander, MD Mount Sinai School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00211809     History of Changes
Other Study ID Numbers: GCO 00-0211PS*
Study First Received: September 13, 2005
Last Updated: May 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Body Dysmorphic Disorder
SRIs
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Disease
Body Dysmorphic Disorders
Pathologic Processes
Somatoform Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014