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| Descriptive Information Fields | |||||
| Brief Title † | Guided Self-Help Treatment for Binge Eating Disorder | ||||
| Official Title † | Binge Eating Self-Guided Treatment (BEST) | ||||
| Brief Summary | This study will determine the effectiveness of guided self-help treatment in treating individuals with binge eating disorder (BED). |
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| Detailed Description | Binge eating disorder (BED) is a serious condition characterized by compulsive overeating and feelings of powerlessness. The condition often has a negative impact on both physical and emotional health. This study will examine ways to help people determine whether they have BED and will test whether guided self-help (GSH) treatment is effective in treating BED. Participants will be randomly assigned to receive either GSH treatment or usual clinical care (which may include general support and talk therapy) for 3 months. The GSH treatment is a cognitive behavioral therapy-based program that will be administered over 8 sessions. Participants receiving GSH will be given a book that focuses on dealing with BED; they will also meet with a therapist regularly to have their progress monitored. The Eating Disorders Examination (EDE), self-reports, questionnaires, and surveys will be used to assess participants. Assessments will be conducted at study entry, at Weeks 2 and 4 of the treatment, at the end of the treatment, and at 6 and 12 months post-treatment. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Frequency of binge eating [ Time Frame: Measured at post-treatment, Week 12, Month 6, and Year 1 ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Frequency of inappropriate compensatory behaviors, dietary restraint, over-valuation of weight/shape, functional impairment, self-esteem, and social impairment [ Time Frame: Measured at post-treatment, Week 12, Month 6, and Year 1 ] [ Designated as safety issue: No ] Body weight [ Time Frame: Measured at post-treatmentand Year 1 ] [ Designated as safety issue: No ] |
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| Condition † | Eating Disorders Bulimia |
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| Intervention † | Behavioral: Guided self-help cognitive behavioral therapy (CBT) Behavioral: Usual clinical care |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 280 | ||||
| Start Date † | August 2004 | ||||
| Completion Date | July 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00158340 | ||||
| Organization ID | R01 MH66966 | ||||
| Secondary IDs †† | DSIR 83-ATAS | ||||
| 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 † | September 7, 2005 | ||||
| Last Updated Date | August 29, 2008 | ||||