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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. Identifier: NCT00211809
Recruitment Status : Terminated (low enrollment)
First Posted : September 21, 2005
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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

Condition or disease Intervention/treatment Phase
Body Dysmorphic Disorder Behavioral: Cognitive Behavioral Therapy Drug: Venlafaxine Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Body dysmorphic disorder
Participants with body dysmorphic disorder
Behavioral: Cognitive Behavioral Therapy
standard psychiatric evaluation

Drug: 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

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 16-65
  • A diagnosis of DSM-IV BDD or its delusional variant (delusional disorder, somatic type)
  • Ability to communicate meaningfully with the investigators
  • Competent to provide written consent, if over 18 years old, or competent to provide written assent, if 16-17 years, 11 months
  • Parental consent, if under 18 years old
  • For phase two: must be on a stable therapeutic dose of one of the following SRI medications for at least 8 weeks: fluoxetine, fluvoxamine, venlafaxine, clomipramine, paroxetine, citalopram, or sertraline.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00211809

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United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
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Principal Investigator: Eric Hollander, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Andrea Allen, PhD Icahn School of Medicine at Mount Sinai

Publications of Results:
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Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT00211809    
Other Study ID Numbers: GCO 00-0211PS*
First Posted: September 21, 2005    Key Record Dates
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017
Last Verified: January 2017
Keywords provided by Icahn School of Medicine at Mount Sinai:
Body Dysmorphic Disorder
Cognitive Behavioral Therapy
Additional relevant MeSH terms:
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Body Dysmorphic Disorders
Somatoform Disorders
Mental Disorders
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs