CBT as an Adjunct to SRIs in the Treatment of BDD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00211809|
Recruitment Status : Terminated (low enrollment)
First Posted : September 21, 2005
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Body Dysmorphic Disorder||Behavioral: Cognitive Behavioral Therapy Drug: Venlafaxine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Controlled Trial of Cognitive-Behavioral Therapy as an Adjunct to Serotonin Reuptake Inhibitors in Body Dysmorphic Disorder|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Experimental: Body dysmorphic disorder
Participants with body dysmorphic disorder
Behavioral: Cognitive Behavioral Therapy
standard psychiatric evaluationDrug: Venlafaxine
start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks.
Other Name: Effexor
- Body Dysmorphic Disorder Examination [ Time Frame: baseline and up to 16 weeks ]Body Dysmorphic Disorder Examination - Self Reported (BDDE-SR) score - The BDDE-SR is a 30-item self-rating of BDD symptoms, with a more specific measure of body image dissatisfaction. Each item is rated 0 (no dissatisfaction to 6 (extreme dissatisfaction), with total score from 0 to 180.
- Yale Brown Obsessive Scale [ Time Frame: baseline and up to 16 weeks ]Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) - a 12-item semistructured clinician-rated instrument designed to rate severity of body dysmorphic disorder (BDD) symptoms during the past week. The score for each item ranges from 0 (no symptoms) to 4 (extreme symptoms). The BDD-YBOCS Obsession Subtotal score range is 0-20 and the BDD-YBOCS Compulsion Subtotal score range is 0-20. The BDD-YBOCS Insight/Avoidance Subtotal score range is 0-8. The total BDD-YBOCS score range is from 0 (not present or extremely mild) to 48 (severe). Each item is rated as a composite of all the patient's appearance related obsessions and compulsive behaviors independent of their content.
- Body Dysmorphic Disorder Clinical Global Impressions Scale [ Time Frame: baseline and up to 16 weeks ]The Clinical Global Impression-Improvement Scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
- Brown Assessment of Beliefs Scale [ Time Frame: Baseline and up to 16 weeks ]The Brown Assessment of Beliefs Scale (BABS) rates the degree of conviction and insight patients have concerning their beliefs. The BABS consists of 7 items: the first 6 items are added to obtain the total BABS score. An additional item (ideas of reference) is not included in the total score. Scoring is from 0 (least severe) to 4 (most severe), with total score from 0 to 24.
- Beck Depression Inventory II [ Time Frame: Baseline and up to 16 weeks ]The Beck Depression Inventory II (BDI-II) is a 21 item self-report inventory measuring the severity of depression. Individuals are asked to respond to each question based on a two-week time period. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.
- Beck Anxiety Inventory [ Time Frame: Baseline and up to 16 weeks ]The Beck Anxiety Inventory (BAI) is a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211809
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029-6574|
|Principal Investigator:||Eric Hollander, MD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Andrea Allen, PhD||Icahn School of Medicine at Mount Sinai|