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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00494858 |
This study will compare the effectiveness of two types of cognitive behavioral therapy in treating adult women with the dysregulated subtype of bulimia nervosa.
Condition | Intervention | Phase |
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Eating Disorders |
Behavioral: Cognitive behavioral therapy - focused (CBT-EF) Behavioral: Cognitive behavioral therapy - broad (EB) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Bulimia Nervosa: Dysregulated Subtype |
Estimated Enrollment: | 74 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
CBT-EF: Active Comparator
Participants will receive cognitive behavioral therapy - focused
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Behavioral: Cognitive behavioral therapy - focused (CBT-EF)
Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months.
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CBT-EB: Experimental
Participants will receive cognitive behavioral therapy - broad
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Behavioral: Cognitive behavioral therapy - broad (EB)
Broad CBT addresses symptoms of BN, as well as those of the personality disorder. CBT-EB incorporates ED interventions from CBT-EF but also has modules focused on addressing mood intolerance and interpersonal difficulties. There will be 20 sessions over 5 months.
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Bulimia nervosa (BN) is a common eating disorder that is characterized by periods of bingeing and purging. People with the dysregulated subtype of BN experience behavioral impulsivity; disruption of cognitive, affective, behavioral, and neurophysiological processes (dysregulation); interpersonal dysfunction; and poor treatment response. To date, no therapies have been tested for this specific population, and it is unknown whether therapy that directly focuses on treating BN symptoms or one that addresses both eating and personality disorder symptoms is more effective. Cognitive behavioral therapy (CBT), which concentrates on modifying patients' behaviors and ways of thinking, has been effective in treating BN. This study will compare the effectiveness of two types of CBT, focused and broad, in treating adult women with the dysregulated subtype of BN.
Participants in this single-blind study will be randomly assigned to receive 20 sessions of either broad (enhanced) or focused CBT. Participants will meet with a therapist once or twice weekly until 20 sessions have occurred. Broad CBT will address symptoms of BN, as well as those of the personality disorder. Focused CBT will concentrate only on BN symptoms. Before treatment begins, participants will complete a set of questionnaires pertaining to their experiences with BN, depression, anxiety, and interpersonal relationships. The questionnaires will be used throughout the study to assess participants' progress. Participants will also attend a clinical interview lasting approximately 3.5 hours. Questions will concern BN, other eating disorder symptoms, depression, anxiety, and interpersonal relationships. Blood samples and vital signs will also be taken at the time of the clinical interview and as needed later in the treatment process.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heather Thompson-Brenner, PhD | 617-353-9610 | ht141@hotmail.com |
Contact: Dana Satir, MA | 617-353-9610 | dana.satir@gmail.com |
United States, Massachusetts | |
Center for Anxiety and Related Disorders, Boston University | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Heather Thompson-Brenner, PhD 617-353-9610 ht141@hotmail.com | |
Contact: Dana Satir, MA 617-353-9610 dana.satir@gmail.com | |
Principal Investigator: Heather Thompson-Brenner, PhD |
Principal Investigator: | Heather Thompson-Brenner, PhD | Center for Anxiety and Related Disorders, Boston University |
Responsible Party: | Center for Anxiety and Related Disorders ( Heather Thompson-Brenner ) |
Study ID Numbers: | K23 MH71641, DATR AK-TNAI2 |
Study First Received: | June 28, 2007 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00494858 |
Health Authority: | United States: Federal Government |
Bulimia nervosa Cognitive Behavioral Therapy Personality Disorders |
Signs and Symptoms Bulimia Nervosa Signs and Symptoms, Digestive Mental Disorders |
Bulimia Eating Disorders Hyperphagia Personality Disorders |