Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder
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|ClinicalTrials.gov Identifier: NCT01453439|
Recruitment Status : Unknown
Verified March 2016 by Sabine Wilhelm, National Institute of Mental Health (NIMH).
Recruitment status was: Recruiting
First Posted : October 17, 2011
Last Update Posted : March 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Body Dysmorphic Disorder Obsessive-Compulsive Spectrum Disorder Anxiety Disorders Somatoform Disorders||Behavioral: Cognitive Behavioral Therapy Behavioral: Supportive Psychotherapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||CBT Versus Supportive Psychotherapy for Body Dysmorphic Disorder|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
Experimental: Cognitive Behavioral Therapy
Group receiving Cognitive-Behavioral Therapy
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.
Other Name: CBT
Active Comparator: Supportive Psychotherapy
Group receiving Supportive Psychotherapy
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.
Other Name: SPT
- Body Dysmorphic Disorder Symptoms (as measured by the BDD-YBOCS) [ Time Frame: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 24) ]
- Insight regarding BDD Symptoms (as measured by the BABS) [ Time Frame: Measured every six weeks during treatment, and at the 3- and 6-month follow-up visits ]
- Depressive symptoms (as measured by the BDI-II) [ Time Frame: Measured every week during treatment, and at the 3- and 6-month follow-up visits ]
- Functioning and life satisfaction (as measured by the SDS and Q-LESQ-SF) [ Time Frame: Measured every six weeks during treatment, and at the 3- and 6-month follow-up visits ]
- Treatment credibility and satisfaction with treatment (as measured by the Credibility/Expectancy Rating and CSQ-8) [ Time Frame: Measured four times during the study (week 0 [pre-treatment], week 4, week 12, and week 24 [post-treatment]) ]
- Beliefs about appearance (as measured by the ASI-R) [ Time Frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) ]
- Neuropsychological functioning (as measured by the ROCF) [ Time Frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) ]
- Information processing (as measured by the ERT) [ Time Frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment]) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453439
|Contact: Rachel Schwartz, B.A.||email@example.com|
|Contact: Joseph Donahue, B.A.||firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Claire Nishioka, B.A. 617-643-4357 email@example.com|
|Contact: Barbara Rosemberg, MHA 617-643-3079 firstname.lastname@example.org|
|Principal Investigator: Sabine Wilhelm, Ph.D.|
|United States, Rhode Island|
|Rhode Island Hospital||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Joseph Donahue, B.A. 401-444-1644 email@example.com|
|Principal Investigator: Katharine Phillips, M.D.|
|Principal Investigator:||Sabine Wilhelm, Ph.D.||Massachusetts General Hospital|
|Principal Investigator:||Katharine Phillips, M.D.||Rhode Island Hospital|