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Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sabine Wilhelm, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT01453439
First received: August 30, 2011
Last updated: November 4, 2014
Last verified: November 2014

August 30, 2011
November 4, 2014
August 2011
April 2016   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01453439 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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]) ] [ Designated as safety issue: No ]
  • 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]) ] [ Designated as safety issue: No ]
  • 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]) ] [ Designated as safety issue: No ]
  • 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]) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder
CBT Versus Supportive Psychotherapy for Body Dysmorphic Disorder

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Body Dysmorphic Disorder
  • Obsessive-Compulsive Spectrum Disorder
  • Anxiety Disorders
  • Somatoform Disorders
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
April 2016
April 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Rachel Schwartz, B.A. 877-464-4233 bdd@partners.org
Contact: Joseph Donahue, B.A. 401-444-1646 bddprogram@lifespan.org
United States
 
NCT01453439
R01 MH091078, R01MH091078, 2010-P-001021/2
Yes
Sabine Wilhelm, National Institute of Mental Health (NIMH)
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Sabine Wilhelm, Ph.D. Massachusetts General Hospital
Principal Investigator: Katharine Phillips, M.D. Rhode Island Hospital
Massachusetts General Hospital
November 2014

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