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CBT as an Adjunct to SRIs in the Treatment of BDD

This study has been terminated.
(low enrollment)
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT00211809
First received: September 13, 2005
Last updated: January 18, 2017
Last verified: January 2017
  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
Drug: Venlafaxine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Controlled Trial of Cognitive-Behavioral Therapy as an Adjunct to Serotonin Reuptake Inhibitors in Body Dysmorphic Disorder

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 17
Study Start Date: September 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

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
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Eric Hollander, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Andrea Allen, PhD Icahn School of Medicine at Mount Sinai
  More Information

Publications:
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00211809     History of Changes
Other Study ID Numbers: GCO 00-0211PS*
Study First Received: September 13, 2005
Results First Received: January 18, 2017
Last Updated: January 18, 2017

Keywords provided by Icahn School of Medicine at Mount Sinai:
Body Dysmorphic Disorder
SRIs
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Body Dysmorphic Disorders
Somatoform Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Venlafaxine Hydrochloride
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 25, 2017