CBT as an Adjunct to SRIs in the Treatment of BDD - Full Text View

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 IV

ChemIDplus related topics:

Serotonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:

Body Dysmorphic Disorder
Yale Brown Obsessive Scale
Body Dysmorphic Disorder Clinical Global Impressions Scale

Secondary Outcome Measures:

Brown Assessment of Beliefs Scale
Beck Depression Inventory II
Beck Anxiety Inventory

Estimated Enrollment:

80

Detailed 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).

Eligibility

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211809

Locations


United States, New York
	Mount Sinai School of Medicine
	New York, New York, United States, 10029-6574

Sponsors and Collaborators

Mount Sinai School of Medicine

Investigators


Principal Investigator:	Eric Hollander, MD	Mount Sinai School of Medicine

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	GCO 00-0211PS*
First Received:	September 13, 2005
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00211809
Health Authority:	United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:

Body Dysmorphic Disorder

SRIs

Cognitive Behavioral Therapy

Study placed in the following topic categories:

Mental Disorders

Somatoform Disorders

Serotonin

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Mount Sinai School of Medicine
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00211809