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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 28, 2007 | ||||||||
| Last Updated Date | April 29, 2009 | ||||||||
| Start Date ICMJE | July 2007 | ||||||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Eating disorder symptoms [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Eating disorder symptoms [ Time Frame: Measured throughout the study ] | ||||||||
| Change History | Complete list of historical versions of study NCT00494858 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa | ||||||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Eating Disorders | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 74 | ||||||||
| Estimated Completion Date | May 2011 | ||||||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00494858 | ||||||||
| Responsible Party | Heather Thompson-Brenner, Center for Anxiety and Related Disorders | ||||||||
| Study ID Numbers ICMJE | K23 MH071641, DATR AK-TNAI2 | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | April 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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