Bulimia Nervosa Clinical Trial
— claireOfficial title:
Development of CBT Model for Adolescent Bulimia Nervosa
Verified date | February 2010 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The claire project is a research study testing the use of Cognitive Behavioral Therapy (CBT) to help teenage girls develop healthier eating habits and better ways to manage weight and shape concerns. The study is enrolling girls who are members of the Kaiser Permanente Health plan in the Northwest region. They must be between the ages of 12 and 18 and report binge eating and/or purging (vomiting, laxative or diuretic use) at a research established threshold to be eligible for the study. Girls enrolled in the study will either receive the 6-20 session CBT intervention at the time of enrollment or 6 months after they enroll. Assessments including questions about eating behaviors, mood, and general functioning are given on enrollment in the study, and 3- and 6-months following enrollment (also at 9- and 12-months for those in the delayed treatment condition).
Status | Completed |
Enrollment | 26 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 12 Years to 18 Years |
Eligibility |
Inclusion Criteria: 1. Ages 12-18, inclusive. 2. Female 3. A DSM-IV diagnosis of current BN or spectrum BN 4. One or both parent(s) willing to participate in study assessments and intervention visit Exclusion Criteria: 1. A current DSM-IV diagnosis of AN. 2. A DSM-IV diagnosis of a psychotic disorder (current or past). 3. Current or past cognitive behavior therapy for an eating disorder or other mental health condition 4. Currently receiving antidepressant medication or medications known to impact weight 5. A significant organic brain syndrome, mental retardation, pervasive developmental disorder or autism. 6. Current pregnancy. 7. Current treatment specifically for ED (not counting medical case management). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Center for Health Research | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recovery from ED (abstinence of all binging and purging during past 28 indices of binge eating, purging, and scores on the EDE-Q5 scale). | 6 months | No | |
Secondary | : changes in other psychiatric symptomatology and | 6 months | No | |
Secondary | associated adaptive functioning and eating concerns | 6 months | No |
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