Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder

Not Applicable

Completed

Conditions: Anxiety Disorders
Body Dysmorphic Disorder
Obsessive-Compulsive Spectrum Disorder
Somatoform Disorders

Interventions: Behavioral: Supportive Psychotherapy
Behavioral: Cognitive Behavioral Therapy

Registration Number: NCT01453439

Lead Sponsor: Massachusetts General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive Psychotherapy	Supportive Psychotherapy	Group receiving Supportive Psychotherapy
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	Group receiving Cognitive-Behavioral Therapy

Primary Outcome Measures

Name	Time	Method
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)	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).

Secondary Outcome Measures

Name	Time	Method
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.	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).
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])
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	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).
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.	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).
Neuropsychological Functioning (as Measured by the ROCF)	Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Information Processing (as Measured by the ERT)	Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Treatment Credibility (Credibility/Expectancy Rating Scale)	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.
Sheehan Disability Scale (SDS)	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 Expectancy (Credibility/Expectancy Rating Scale)	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.
Treatment Satisfaction (CSQ-8)	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.

Trial Locations

Locations (2): Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Rhode Island Hospital
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Providence, Rhode Island, United States