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

September 13, 2005
May 23, 2008
Not Provided
Not Provided
  • Body Dysmorphic Disorder
  • Yale Brown Obsessive Scale
  • Body Dysmorphic Disorder Clinical Global Impressions Scale
Same as current
Complete list of historical versions of study NCT00211809 on ClinicalTrials.gov Archive Site
  • Brown Assessment of Beliefs Scale
  • Beck Depression Inventory II
  • Beck Anxiety Inventory
Same as current
Not Provided
Not Provided
 
CBT as an Adjunct to SRIs in the Treatment of BDD
A Controlled Trial of Cognitive-Behavioral Therapy as an Adjunct to Serotonin Reuptake Inhibitors in Body Dysmorphic Disorder

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

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Body Dysmorphic Disorder
Behavioral: Cognitive Behavioral Therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
Not Provided
Not Provided

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.
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00211809
GCO 00-0211PS*
Not Provided
Not Provided
Mount Sinai School of Medicine
Not Provided
Principal Investigator: Eric Hollander, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP