CBT as an Adjunct to SRIs in the Treatment of BDD
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|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 evaluation
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.
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|