Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder

NCT ID: NCT01453439

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2017-06-07

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Behavioral Therapy

Group receiving Cognitive-Behavioral Therapy

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: 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.

Supportive Psychotherapy

Group receiving Supportive Psychotherapy

Group Type: ACTIVE_COMPARATOR

Supportive Psychotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT; SPT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sabine Wilhelm, PhD

Sabine Wilhelm, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabine Wilhelm, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Katharine Phillips, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30785624 (View on PubMed)

Related Links

http://www.mghocd.org/bdd

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

Other Identifiers

R01MH091078

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010-P-001021/2

Identifier Type: OTHER

Identifier Source: secondary_id

R01MH091078

Identifier Type: NIH

Identifier Source: org_study_id

View Link