Clinical trial NCT01453439: Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder
Official title: CBT Versus Supportive Psychotherapy for Body Dysmorphic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Dysmorphic Disorder
Obsessive-Compulsive Spectrum Disorder
Anxiety Disorders
Somatoform Disorders
Keywords: Body dysmorphic disorder
Obsessive compulsive spectrum disorder
Body image
Appearance concerns
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2011-10-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
timeFrame: 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:
measure: Insight Regarding BDD Beliefs (as Measured by the BABS)
timeFrame: Measured every 4 weeks during treatment, and at the 3-(wk 37) and 6-month(wk 50) follow-up visits
measure: Depressive Symptoms (as Measured by the BDI-II)
timeFrame: 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.
measure: Life Satisfaction (Q-LESQ-SF)
timeFrame: Measured at week 0, 4, 12, 16, and 24 during treatment. Follow-up phase data was measured at week 37 and at week 50.
measure: Treatment Credibility (Credibility/Expectancy Rating Scale)
timeFrame: Measured twice during the study (week 0 [pre-treatment] and at week 4)
measure: Beliefs About Appearance (as Measured by the ASI-R)
timeFrame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
measure: Neuropsychological Functioning (as Measured by the ROCF)
timeFrame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
measure: Information Processing (as Measured by the ERT)
timeFrame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
measure: Sheehan Disability Scale (SDS)
timeFrame: 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.
measure: Treatment Satisfaction (CSQ-8)
timeFrame: The CSQ-8 was assessed twice: at week 12 [mid-treatment] and at week 24 [post-treatment]
measure: Treatment Expectancy (Credibility/Expectancy Rating Scale)
timeFrame: Measured twice during the study (week 0 [pre-treatment] and at week 4)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Massachusetts General Hospital
name: Sabine Wilhelm, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Katharine Phillips, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.