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| Descriptive Information Fields | |||||||||
| Brief Title † | Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa | ||||||||
| Official Title † | Treatment of Bulimia Nervosa: Dysregulated Subtype | ||||||||
| Brief Summary | This study will compare the effectiveness of two types of cognitive behavioral therapy in treating adult women with the dysregulated subtype of bulimia nervosa. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Eating disorder symptoms [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Depression symptoms [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ] Anxiety symptoms [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ] Interpersonal relationships [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ] |
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| Condition † | Eating Disorders | ||||||||
| Intervention † | Behavioral: Cognitive behavioral therapy - focused (CBT-EF) Behavioral: Cognitive behavioral therapy - broad (EB) |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 74 | ||||||||
| Start Date † | July 2007 | ||||||||
| Completion Date | December 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00494858 | ||||||||
| Organization ID | K23 MH71641 | ||||||||
| Secondary IDs †† | DATR AK-TNAI2 | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | June 28, 2007 | ||||||||
| Last Updated Date | August 19, 2008 | ||||||||
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