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Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01453439
Recruitment Status : Completed
First Posted : October 17, 2011
Results First Posted : July 15, 2020
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sabine Wilhelm, PhD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 30, 2011
First Posted Date  ICMJE October 17, 2011
Results First Submitted Date  ICMJE May 18, 2020
Results First Posted Date  ICMJE July 15, 2020
Last Update Posted Date July 15, 2020
Study Start Date  ICMJE August 2011
Actual Primary Completion Date January 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2020)
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) [ Time Frame: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 24), assessed every 4 weeks. Followup phase data was measured at week 37 and week 50. ]
The Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) is a 12-item, semi-structured, clinician-administered measure of BDD symptom severity. The scale's items are summed to yield a total score with a range from 0 to 48, with higher scores indicating more severe BDD symptoms. Treatment effects on BDD symptom severity were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2011)
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) [ Time Frame: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 24) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2020)
  • Insight Regarding BDD Beliefs (as Measured by the BABS) [ Time Frame: Measured every 4 weeks during treatment, and at the 3-(wk 37) and 6-month(wk 50) follow-up visits ]
    The Brown Assessment of Beliefs Scale (BABS) is a 7-item, semi-structured, clinician-administered measure that was used to assess insight regarding BDD-related beliefs (e.g., "I look deformed"). The first six items of the BABS were summed to obtain a total score ranging from 0 to 24, with higher scores reflecting poorer insight. Treatment effects on BABS score were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
  • Depressive Symptoms (as Measured by the BDI-II) [ Time Frame: Measured every week during treatment, but analysis was performed only on BDI-II assessments close to assessment visits; wk 0, 4, 8, 12, 16, 20 and 24. Followup phase data was measured at week 37 and week 50. ]
    The Beck Depression Inventory-Second Edition (BDI-II) is a widely used 21-item self-report scale that assesses the severity of depressive symptoms during the past 2 weeks. Total scale scores range from 0 to 63, with higher scores indicating greater symptom severity. Treatment effects on depression were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
  • Life Satisfaction (Q-LESQ-SF) [ Time Frame: Measured at week 0, 4, 12, 16, and 24 during treatment. Follow-up phase data was measured at week 37 and at week 50. ]
    The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LESQ-SF) is a 16-item, self-report questionnaire that assesses life satisfaction over the past week. Questions 1-14 are then summed to a total score, and the total score is reported as a percentage maximum possible, such that the % score range is 0% to 100%, with higher scores indicating greater quality of life. Treatment effects on life satisfaction were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
  • Treatment Credibility (Credibility/Expectancy Rating Scale) [ Time Frame: Measured twice during the study (week 0 [pre-treatment] and at week 4) ]
    The Treatment Credibility/Expectancy Rating scale is a 4-item self-report questionnaire that assesses patients' judgments about the credibility of the treatment rationale, expectancy of change, and treatment acceptability. Treatment credibility is based on the mean score of the first three items, which are measured on 10-point Likert scales, so that mean scores range from 1 (lowest/worst) to 10 (highest/most). Treatment credibility was assessed at the baseline assessment (before treatment assignment) and after 1 month of treatment when patients are more familiar with the treatment protocol and rationale.
  • Beliefs About Appearance (as Measured by the ASI-R) [ Time Frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) ]
  • Neuropsychological Functioning (as Measured by the ROCF) [ Time Frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) ]
  • Information Processing (as Measured by the ERT) [ Time Frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) ]
  • Sheehan Disability Scale (SDS) [ Time Frame: Measured at baseline, week 4, week 12, week 16, and week 24. Follow-up phase data was measured at week 37 and at week 50. ]
    The Sheehan Disability Scale (SDS) is a 5-item self-report measure of functional impairment/disability. Items 1-3 (disability in work, social life/leisure, and family life/home responsibilities, respectively) are scored on Likert-scales that range from 0 (not at all) to 10 (extreme). The three items are then summed to yield an SDS total score, ranging from 0 (unimpaired) to 30 (highly impaired). Treatment effects on functional impairment were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
  • Treatment Satisfaction (CSQ-8) [ Time Frame: The CSQ-8 was assessed twice: at week 12 [mid-treatment] and at week 24 [post-treatment] ]
    The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report questionnaire that assesses satisfaction with clinical services received and has a score range of 8-32, where higher scores indicate higher satisfaction.
  • Treatment Expectancy (Credibility/Expectancy Rating Scale) [ Time Frame: Measured twice during the study (week 0 [pre-treatment] and at week 4) ]
    The Treatment Credibility/Expectancy Rating scale is a 4-item self-report questionnaire that assesses patients' judgments about the credibility of the treatment rationale, expectancy of change, and treatment acceptability. Treatment expectancy is a single item rating of "By the end of therapy, how much improvement in your anxiety do you think will occur?", rated on a scale from 0% to 100%. It was assessed at the baseline assessment (before treatment assignment) and after 1 month of treatment when patients are more familiar with the treatment protocol and rationale.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2011)
  • Insight regarding BDD Symptoms (as measured by the BABS) [ Time Frame: Measured every six weeks during treatment, and at the 3- and 6-month follow-up visits ]
  • Depressive Symptoms (as Measured by the BDI-II) [ Time Frame: Measured every week during treatment, and at the 3- and 6-month follow-up visits ]
  • Functioning and life satisfaction (as measured by the SDS and Q-LESQ-SF) [ Time Frame: Measured every six weeks during treatment, and at the 3- and 6-month follow-up visits ]
  • Treatment credibility and satisfaction with treatment (as measured by the Credibility/Expectancy Rating and CSQ-8) [ Time Frame: Measured four times during the study (week 0 [pre-treatment], week 4, week 12, and week 24 [post-treatment]) ]
  • Beliefs About Appearance (as Measured by the ASI-R) [ Time Frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) ]
  • Neuropsychological Functioning (as Measured by the ROCF) [ Time Frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) ]
  • Information Processing (as Measured by the ERT) [ Time Frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder
Official Title  ICMJE CBT Versus Supportive Psychotherapy for Body Dysmorphic Disorder
Brief Summary The purpose of this study is to learn more about two different types of psychotherapy to help individuals who have body dysmorphic disorder (BDD). BDD is a severe, often chronic, and common disorder consisting of distressing or impairing preoccupation with perceived defects in one's physical appearance. Individuals with BDD have very poor psychosocial functioning and high rates of hospitalization and suicidality. Because BDD differs in important ways from other disorders, psychotherapies for other disorders are not adequate for BDD. Despite BDD's severity, there is no adequately tested psychosocial treatment (psychotherapy) of any type for this disorder. This study will compare the effectiveness of Cognitive Behavioral Therapy and Supportive Psychotherapy as well as predictors of improvement.
Detailed Description

Body Dysmorphic Disorder (BDD) is a common and severe disorder in which a person is preoccupied by perceived defects in his or her appearance. The purpose of this research study is to learn more about two different forms of therapy to help individuals with BDD: cognitive behavioral therapy (CBT), a promising new treatment for BDD, and supportive psychotherapy (SPT), the most commonly received therapy for BDD. The investigators would like to find out which treatment is more effective for BDD. The investigators will also examine patient characteristics that may predict response to treatment.

Participants will be randomly assigned (like the flip of a coin) to receive 22 sessions (over 24 weeks) of either CBT or SPT. Both treatments teach participants about BDD. CBT focuses on helping participants to develop more adaptive thoughts and beliefs and to gradually reduce avoidance and compulsive (repetitive) behaviors. SPT focuses on relationships, feelings, and other factors that may affect BDD symptoms (e.g., work, stress), and helps participants to cope with challenges in their life by improving self-esteem and positive coping.

For each participant, this study will last for 12 months. CBT and SPT sessions occur for 22 sessions over 24 weeks. The severity of participants' BDD-related symptoms and other symptoms will be assessed at the end of treatment (week 24), and at 3- and 6-months after treatment ends.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Body Dysmorphic Disorder
  • Obsessive-Compulsive Spectrum Disorder
  • Anxiety Disorders
  • Somatoform Disorders
Intervention  ICMJE
  • Behavioral: Cognitive Behavioral Therapy
    Participants will receive a total of 22 sessions (over 24 weeks) of individual, manual-based CBT. During the sessions, participants will receive education about BDD and CBT, learn to develop more helpful thoughts and beliefs, gradually enter anxiety provoking situations while reducing compulsions (repetitive behaviors), and learn relapse prevention techniques.
    Other Name: CBT
  • Behavioral: Supportive Psychotherapy
    Participants will receive a total of 22 sessions (over 24 weeks) of individual, manual-based SPT. During the sessions, participants will receive education about BDD and SPT, learn about factors that may affect their symptoms (for example, relationships, work, stress), and learn to cope with challenges in their life by improving self-esteem and positive coping skills.
    Other Name: SPT
Study Arms  ICMJE
  • Experimental: Cognitive Behavioral Therapy
    Group receiving Cognitive-Behavioral Therapy
    Intervention: Behavioral: Cognitive Behavioral Therapy
  • Active Comparator: Supportive Psychotherapy
    Group receiving Supportive Psychotherapy
    Intervention: Behavioral: Supportive Psychotherapy
Publications * Wilhelm S, Phillips KA, Greenberg JL, O'Keefe SM, Hoeppner SS, Keshaviah A, Sarvode-Mothi S, Schoenfeld DA. Efficacy and Posttreatment Effects of Therapist-Delivered Cognitive Behavioral Therapy vs Supportive Psychotherapy for Adults With Body Dysmorphic Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Apr 1;76(4):363-373. doi: 10.1001/jamapsychiatry.2018.4156.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2011)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 7, 2017
Actual Primary Completion Date January 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Outpatient men and women age 18 and older
  • DSM-IV BDD or its delusional variant for at least 6 months
  • BDD is the most problematic psychiatric disorder (in the patient's and clinician's opinion) and the primary reason for seeking treatment
  • Score of 24 or higher on the BDD-Yale-Brown Obsessive Compulsive Scale

Exclusion Criteria:

  • Current clinically significant suicidality and/or score on the BDI-II suicide item (#9) > 1
  • Any clinical features requiring a higher level of care
  • Mental retardation or borderline intellectual functioning (estimated IQ < 80 on the Wechsler Abbreviated Scale of Intelligence) or dementia, brain damage, or other cognitive impairment that would interfere with ability to engage in CBT
  • DSM-IV substance abuse or dependence within the past 3 months; or a positive urine drug screen for any illicit substances of abuse
  • Current manic episode
  • Psychotic disorder
  • Borderline personality disorder
  • Body image concerns accounted for by an eating disorder
  • Previous treatment with > 10 sessions of CBT for BDD
  • Subjects cannot be receiving any other psychotherapy or begin such treatment during the study
  • Patients can be receiving psychotropic medication if they have taken a stable dose for at least two months before the study baseline assessment and the dose remains stable during the study.
  • Presence of any behavior (e.g., violence) that would interfere with full cooperation with the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01453439
Other Study ID Numbers  ICMJE R01MH091078( U.S. NIH Grant/Contract )
R01MH091078 ( U.S. NIH Grant/Contract )
2010-P-001021/2 ( Other Identifier: Institutional Review Board )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sabine Wilhelm, PhD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Sabine Wilhelm, Ph.D. Massachusetts General Hospital
Principal Investigator: Katharine Phillips, M.D. Rhode Island Hospital
PRS Account Massachusetts General Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP