Body Dysmorphic DisorderPhase 4NCT00211809
CBT as an Adjunct to SRIs in the Treatment of BDD
A Phase 4 study testing Cognitive Behavioral Therapy and Venlafaxine in people with Body Dysmorphic Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Body Dysmorphic Disorder
- What is being tested?
- Cognitive Behavioral Therapy and Venlafaxine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029-6574
About this study
Official title: 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
Read the 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).
- Conditions
- Body Dysmorphic Disorder
- Being tested
- Cognitive Behavioral Therapy, Venlafaxine
- Keywords
- Body Dysmorphic Disorder, SRIs, Cognitive Behavioral Therapy
- Medical subject headings
- Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
standard psychiatric evaluation
VenlafaxineDrug
Also called Effexor
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.
| Study group | Role | What they receive |
|---|---|---|
| Body dysmorphic disorder | Experimental | Participants with body dysmorphic disorder Receives: Behavioral: Cognitive Behavioral Therapy; Drug: Venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline and up to 16 weeks
Secondary outcomes (3)
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.
Measured: Baseline and up to 16 weeks
Beck Depression Inventory II
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.
Measured: Baseline and up to 16 weeks
Beck Anxiety Inventory
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.
Measured: Baseline and up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Hollander, MD, Principal investigator, Icahn School of Medicine at Mount SinaiAndrea Allen, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211809
- Sponsor's protocol ID
- GCO 00-0211PS*
- Status last verified
- Jan 2017
- First submitted
- 13 Sep 2005
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18227745
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial of Cognitive-Behavioral Therapy as an Adjunct to Serotonin Reuptake Inhibitors in Body Dysmorphic Disorder
- ClinicalTrials.gov ID
- NCT00211809
- Acronym / sponsor ID
- GCO 00-0211PS*
- Conditions
- Body Dysmorphic Disorder
- Keywords
- Body Dysmorphic Disorder, SRIs, Cognitive Behavioral Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 9 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body dysmorphic disorder | Experimental | Behavioral: Cognitive Behavioral Therapy, Drug: VenlafaxineParticipants with body dysmorphic disorder |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapystandard psychiatric evaluation | Behavioural | Body dysmorphic disorder |
| VenlafaxineAlso: Effexorstart 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. | Drug | Body dysmorphic disorder |
Primary outcome
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.
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.
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.
3 secondary outcomes
Brown Assessment of Beliefs Scale
Time frame: Baseline and up to 16 weeks
Beck Depression Inventory II
Time frame: Baseline and up to 16 weeks
Beck Anxiety Inventory
Time frame: Baseline and up to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18227745Allen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hollander, MD principal investigator
Icahn School of Medicine at Mount Sinai
Andrea Allen, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive Behavioral Therapy and Venlafaxine in people with Body Dysmorphic Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Dysmorphic Disorder Examination (time frame: baseline and up to 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00211809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.