Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Body Dysmorphic Disorder
Obsessive-Compulsive Spectrum Disorder
Anxiety Disorders
Somatoform Disorders
Behavioral: Cognitive Behavioral Therapy
Behavioral: Supportive Psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CBT Versus Supportive Psychotherapy for Body Dysmorphic Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Therapy
Group receiving Cognitive-Behavioral Therapy
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
Active Comparator: Supportive Psychotherapy
Group receiving Supportive Psychotherapy
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453439

Contacts
Contact: Rachel Schwartz, B.A. 877-464-4233 bdd@partners.org
Contact: Joseph Donahue, B.A. 401-444-1646 bddprogram@lifespan.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rachel Schwartz, B.A.    877-464-4233    bdd@partners.org   
Contact: Jennifer Greenberg, Psy.D.    617-726-5374    jlgreenberg@partners.org   
Principal Investigator: Sabine Wilhelm, Ph.D.         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Joseph Donahue, B.A.    401-444-1644    bddprogram@lifespan.org   
Principal Investigator: Katharine Phillips, M.D.         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Sabine Wilhelm, Ph.D. Massachusetts General Hospital
Principal Investigator: Katharine Phillips, M.D. Rhode Island Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Sabine Wilhelm, Sabine Wilhelm, PhD, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT01453439     History of Changes
Other Study ID Numbers: R01 MH091078, R01MH091078, 2010-P-001021/2
Study First Received: August 30, 2011
Last Updated: May 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Body dysmorphic disorder
Obsessive compulsive spectrum disorder
Body image
Appearance concerns

Additional relevant MeSH terms:
Anxiety Disorders
Body Dysmorphic Disorders
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014