- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00211809
CBT as an Adjunct to SRIs in the Treatment of BDD
January 18, 2017 updated by: Icahn School of Medicine at Mount Sinai
A Controlled Trial of Cognitive-Behavioral Therapy as an Adjunct to Serotonin Reuptake Inhibitors in Body Dysmorphic Disorder
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
Study Overview
Status
Terminated
Conditions
Intervention / 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).
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10029-6574
- Mount Sinai School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Body dysmorphic disorder
Participants with body dysmorphic disorder
|
standard psychiatric evaluation
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline and up to 16 weeks
|
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.
|
baseline and up to 16 weeks
|
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.
|
baseline and up to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and up to 16 weeks
|
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.
|
Baseline and up to 16 weeks
|
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.
|
Baseline and up to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrea Allen, PhD, Icahn School of Medicine at Mount Sinai
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Actual)
March 9, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Somatoform Disorders
- Body Dysmorphic Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Venlafaxine Hydrochloride
Other Study ID Numbers
- GCO 00-0211PS*
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Body Dysmorphic Disorder
-
Karolinska InstitutetCompletedBody Dysmorhpic DisorderSweden
-
Karolinska InstitutetVastra Gotaland Region; Region Skane; Region StockholmRecruitingBody Dysmorphic DisordersSweden
-
Massachusetts General HospitalTelefónica S.A.CompletedBody Dysmorphic DisordersUnited States
-
Institute of Psychiatry, LondonCompletedBody Dysmorphic DisorderUnited Kingdom
-
Massachusetts General HospitalCompleted
-
Westwood Institute for Anxiety Disorders, IncUnknownBody Dysmorphic DisordersUnited States
-
Centre for Addiction and Mental HealthUniversity Health Network, TorontoRecruiting
-
Koa Health B.V.Massachusetts General HospitalActive, not recruitingBody Dysmorphic DisordersUnited States
-
Florida State UniversityCompletedBody Dysmorphic DisorderUnited States
-
Massachusetts General HospitalCompletedBody Dysmorphic DisorderUnited States
Clinical Trials on Cognitive Behavioral Therapy
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States
-
Regionsenter for barn og unges psykiske helseThe Research Council of NorwayCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety DisorderNorway
-
Claremont McKenna CollegeUniversity of California, Los AngelesCompleted
-
University of South FloridaObsessive Compulsive FoundationCompletedObsessive Compulsive Disorder | Stepped Care Cognitive Behavioral TherapyUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedDepression | Sleep | Stress Disorders, Post-TraumaticUnited States
-
University of PittsburghWithdrawnPsychosis | Prodromal Symptoms | Prodromal Stage | Prodromal StatesUnited States
-
Duke UniversityCompleted
-
The University of Texas Health Science Center at...59th Medical Wing; Brooke Army Medical Center; South Texas Veterans Health Care...CompletedCombat Disorders | Post-Traumatic Stress Disorders | Stress DisordersUnited States
-
UConn HealthCompletedObsessive-Compulsive DisorderUnited States