CBT as an Adjunct to SRIs in the Treatment of BDD

Phase 4TerminatedNCT00211809

Icahn School of Medicine at Mount Sinai17 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Body Dysmorphic Disorder

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

standard psychiatric evaluation

VenlafaxineDRUG

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.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mount Sinai School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: baseline and up to 16 weeks

Secondary Outcomes

Brown Assessment of Beliefs Scale

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.

Data from ClinicalTrials.gov

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