CBT as an Adjunct to SRIs in the Treatment of BDD
This trial is active, not recruiting.
|Condition||body dysmorphic disorder|
|Treatment||cognitive behavioral therapy|
|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
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Body Dysmorphic Disorder
Yale Brown Obsessive Scale
Body Dysmorphic Disorder Clinical Global Impressions Scale
Brown Assessment of Beliefs Scale
Beck Depression Inventory II
Beck Anxiety Inventory
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.
|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).|
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