CBT as an Adjunct to SRIs in the Treatment of BDD
Recruitment status was Active, not recruiting
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Purpose
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 Endpoint Classification: Efficacy Study 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 |
- 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
| Estimated Enrollment: | 80 |
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).
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029-6574 | |
| Principal Investigator: | Eric Hollander, MD | Mount Sinai School of Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00211809 History of Changes |
| Other Study ID Numbers: | GCO 00-0211PS* |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 23, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mount Sinai School of Medicine:
|
Body Dysmorphic Disorder SRIs Cognitive Behavioral Therapy |
Additional relevant MeSH terms:
|
Body Dysmorphic Disorders Somatoform Disorders Mental Disorders Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013