Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder

NCT01453439 | Completed Results DMC

• 2 other identifiers: R01MH0910782010-P-001021/2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Body Dysmorphic Disorder; Obsessive-Compulsive Spectrum Disorder; Anxiety Disorders; Somatoform Disorders

Keywords

Body dysmorphic disorder; Obsessive compulsive spectrum disorder; Body image; Appearance concerns

Outcome Measures

Primary Outcomes (1)

• Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)

  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).

  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.

Secondary Outcomes (10)

• Insight Regarding BDD Beliefs (as Measured by the BABS)

  Measured every 4 weeks during treatment, and at the 3-(wk 37) and 6-month(wk 50) follow-up visits

• Depressive Symptoms (as Measured by the BDI-II)

  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.

• Life Satisfaction (Q-LESQ-SF)

  Measured at week 0, 4, 12, 16, and 24 during treatment. Follow-up phase data was measured at week 37 and at week 50.

• Treatment Credibility (Credibility/Expectancy Rating Scale)

  Measured twice during the study (week 0 [pre-treatment] and at week 4)

• Beliefs About Appearance (as Measured by the ASI-R)

  Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

Group receiving Cognitive-Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy

Supportive Psychotherapy

ACTIVE COMPARATOR

Group receiving Supportive Psychotherapy

Behavioral: Supportive Psychotherapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: CBT

Cognitive Behavioral Therapy

Supportive Psychotherapy BEHAVIORAL

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.

Also known as: SPT

Supportive Psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• 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.

  PMID: 30785624 DERIVED

Related Links

• Click here to visit the official website of the Body Dysmorphic Disorder Clinic at MGH

MeSH Terms

Conditions

Body Dysmorphic Disorders; Anxiety Disorders; Somatoform Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Sabine Wilhelm, Ph.D.
• Organization: Massachusetts General Hospital

swilhelm@mgh.harvard.edu

+1(617)724-6146

Study Officials

• Sabine Wilhelm, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Katharine Phillips, M.D.

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sabine Wilhelm, PhD

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: October 17, 2011
• Study Start: August 1, 2011
• Primary Completion: January 5, 2017
• Study Completion: June 7, 2017
• Last Updated: July 15, 2020
• Results First Posted: July 15, 2020

Record last verified: 2020-07

Locations

US (2)