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CBT as an Adjunct to SRIs in the Treatment of BDD

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Icahn School of Medicine at Mount Sinai.
Recruitment status was:  Active, not recruiting
Information provided by:
Icahn School of Medicine at Mount Sinai Identifier:
First received: September 13, 2005
Last updated: May 23, 2008
Last verified: May 2008
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
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

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

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).

Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00211809

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Principal Investigator: Eric Hollander, MD Icahn School of Medicine at Mount Sinai
  More Information Identifier: NCT00211809     History of Changes
Other Study ID Numbers: GCO 00-0211PS* 
Study First Received: September 13, 2005
Last Updated: May 23, 2008

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

Additional relevant MeSH terms:
Body Dysmorphic Disorders
Somatoform Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs processed this record on February 27, 2017