Clinical Trial: CBT as an Adjunct to SRIs in the Treatment of BDD

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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

Detailed Summary: 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).
Sponsor: Icahn School of Medicine at Mount Sinai

Current Primary Outcome:

  • 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.

    Original Primary Outcome:

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


    Current Secondary Outcome:

    • 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.


    Original Secondary Outcome:

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


    Information By: Icahn School of Medicine at Mount Sinai

    Dates:
    Date Received: September 13, 2005
    Date Started: September 2008
    Date Completion:
    Last Updated: January 18, 2017
    Last Verified: January 2017