Clinical trial NCT00211809: CBT as an Adjunct to SRIs in the Treatment of BDD
Official title: A Controlled Trial of Cognitive-Behavioral Therapy as an Adjunct to Serotonin Reuptake Inhibitors in Body Dysmorphic Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Body Dysmorphic Disorder
Keywords: Body Dysmorphic Disorder
SRIs
Cognitive Behavioral Therapy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 17
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Body Dysmorphic Disorder Examination
timeFrame: baseline and up to 16 weeks
measure: Yale Brown Obsessive Scale
timeFrame: baseline and up to 16 weeks
measure: Body Dysmorphic Disorder Clinical Global Impressions Scale
timeFrame: baseline and up to 16 weeks
Secondary outcomes:
measure: Brown Assessment of Beliefs Scale
timeFrame: Baseline and up to 16 weeks
measure: Beck Depression Inventory II
timeFrame: Baseline and up to 16 weeks
measure: Beck Anxiety Inventory
timeFrame: Baseline and up to 16 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Eric Hollander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Andrea Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.