This trial is active, not recruiting.

Condition body dysmorphic disorder
Treatment cognitive behavioral therapy
Phase phase 4
Sponsor Mount Sinai School of Medicine
Trial size 80 participants
Trial identifier NCT00211809, GCO 00-0211PS*


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Body Dysmorphic Disorder
time frame:
Yale Brown Obsessive Scale
time frame:
Body Dysmorphic Disorder Clinical Global Impressions Scale
time frame:

Secondary Outcomes

Brown Assessment of Beliefs Scale
time frame:
Beck Depression Inventory II
time frame:
Beck Anxiety Inventory
time frame:

Eligibility Criteria

Male or female participants from 16 years up to 65 years old.

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.

Additional Information

Official title A Controlled Trial of Cognitive-Behavioral Therapy as an Adjunct to Serotonin Reuptake Inhibitors in Body Dysmorphic Disorder
Principal investigator Eric Hollander, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Mount Sinai School of Medicine.