CBT as an Adjunct to SRIs in the Treatment of BDD

Body Dysmorphic Disorder Clinical Trial

Official title:

A Controlled Trial of Cognitive-Behavioral Therapy as an Adjunct to Serotonin Reuptake Inhibitors in Body Dysmorphic Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00211809
• Other study ID #: GCO 00-0211PS*
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: May 23, 2008

Study information

• Verified date: May 2008
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Dysmorphic Disorder
• Body Dysmorphic Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Dysmorphic Disorder
Primary	Yale Brown Obsessive Scale
Primary	Body Dysmorphic Disorder Clinical Global Impressions Scale
Secondary	Brown Assessment of Beliefs Scale
Secondary	Beck Depression Inventory II
Secondary	Beck Anxiety Inventory