Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder

Anxiety Disorders Clinical Trial

Official title:

CBT Versus Supportive Psychotherapy for Body Dysmorphic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453439
• Other study ID #: R01MH091078
• Secondary ID: R01MH0910782010-
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: June 7, 2017

Study information

• Verified date: July 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 7, 2017
• Est. primary completion date: January 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Body Dysmorphic Disorder
• Body Dysmorphic Disorders
• Disease
• Obsessive-Compulsive Spectrum Disorder
• Somatoform Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Insight Regarding BDD Beliefs (as Measured by the BABS)	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).	Measured every 4 weeks during treatment, and at the 3-(wk 37) and 6-month(wk 50) follow-up visits
Secondary	Depressive Symptoms (as Measured by the BDI-II)	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).	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.
Secondary	Life Satisfaction (Q-LESQ-SF)	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).	Measured at week 0, 4, 12, 16, and 24 during treatment. Follow-up phase data was measured at week 37 and at week 50.
Secondary	Treatment Credibility (Credibility/Expectancy Rating Scale)	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.	Measured twice during the study (week 0 [pre-treatment] and at week 4)
Secondary	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])
Secondary	Neuropsychological Functioning (as Measured by the ROCF)		Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Secondary	Information Processing (as Measured by the ERT)		Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Secondary	Sheehan Disability Scale (SDS)	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).	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.
Secondary	Treatment Satisfaction (CSQ-8)	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.	The CSQ-8 was assessed twice: at week 12 [mid-treatment] and at week 24 [post-treatment]
Secondary	Treatment Expectancy (Credibility/Expectancy Rating Scale)	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.	Measured twice during the study (week 0 [pre-treatment] and at week 4)

External Links

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