CBT as an Adjunct to SRIs in the Treatment of BDD

NCT00211809 | Terminated Phase 4 Results

• 1 other identifier: GCO 00-0211PS*
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Body Dysmorphic Disorder

Keywords

Body Dysmorphic Disorder; SRIs; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (3)

• Body Dysmorphic Disorder Examination

  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.

  baseline and up to 16 weeks

• Yale Brown Obsessive Scale

  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.

  baseline and up to 16 weeks

• Body Dysmorphic Disorder Clinical Global Impressions Scale

  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.

  baseline and up to 16 weeks

Secondary Outcomes (3)

• Brown Assessment of Beliefs Scale

  Baseline and up to 16 weeks

• Beck Depression Inventory II

  Baseline and up to 16 weeks

• Beck Anxiety Inventory

  Baseline and up to 16 weeks

Study Arms (1)

Body dysmorphic disorder

EXPERIMENTAL

Participants with body dysmorphic disorder

Behavioral: Cognitive Behavioral Therapy; Drug: Venlafaxine

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

standard psychiatric evaluation

Body dysmorphic disorder

Venlafaxine DRUG

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.

Also known as: Effexor

Body dysmorphic disorder

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029-6574, United States

Location

Related Publications (1)

• Allen A, Hadley SJ, Kaplan A, Simeon D, Friedberg J, Priday L, Baker BR, Greenberg JL, Hollander E. An open-label trial of venlafaxine in body dysmorphic disorder. CNS Spectr. 2008 Feb;13(2):138-44. doi: 10.1017/s1092852900016291.

  PMID: 18227745 RESULT

MeSH Terms

Conditions

Body Dysmorphic Disorders

Interventions

Cognitive Behavioral Therapy; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Limitations and Caveats

The primary limitations of this study are the small sample size, the open-label design, and the primarily female sample.

Results Point of Contact

• Title: Dr. Andrea Allen
• Organization: Icahn School of Medicine at Mount Sinai

andrea.allen@mssm.edu

212-241-3176

Study Officials

• Eric Hollander, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Andrea Allen, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-01

Locations

US (1)