CBT as an Adjunct to SRIs in the Treatment of BDD

Mount Sinai Health System

Status and phase

Terminated

Phase 4

Conditions

Body Dysmorphic Disorder

Treatments

Drug: Venlafaxine

Behavioral: Cognitive Behavioral Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00211809

GCO 00-0211PS*

Details and patient eligibility

About

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

Full 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).

Enrollment

17 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

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.