Cognitive Behavioral Therapy to Treat Bulimia Nervosa in Adolescents
Condition: Bulimia Nervosa
MeSH terms: Bulimia; Bulimia Nervosa
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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).
    

Detailed description: 
      The overall aim of this study is to develop a manual-based cognitive behavioral therapy (CBT)
      intervention to treat bulimia nervosa spectrum conditions (BN and EDNOS) in adolescents
      identified with these conditions in a large HMO in the Pacific Northwest. Eating disorders
      are among the most common, impairing, and serious mental health problems-particularly among
      women. BN and its subclinical variants usually arise in adolescence and affects as many as
      10% of young women. Yet despite the significance of these conditions, there are no systematic
      studies of empirically-based interventions for adolescents with BN and EDNOS. We propose to
      design an intervention based on the adult CBT model, addressing developmental considerations
      of adolescents, as well as the risk and maintaining factors of adolescent BN/EDNOS. In
      addition to developing the adolescent-specific CBT protocol, we will evaluate adolescent,
      family, and medical provider satisfaction with this intervention. We will estimate
      effect-size and effect-size variability of this intervention's impact on primary (binge and
      purge cessation and frequency) and secondary outcomes measured post-treatment and at a
      6-month follow-up. These results will inform a subsequent, full-scale, randomized clinical
      trial. We will develop the intervention in two distinct phases. The first phase (months 1 to
      18) will consist of at least two development cycles of the adolescent BN-CBT program. In each
      cycle, we will draft a version of the intervention, test it with several clinical cases,
      obtain feedback from adolescents and their parents, and then generate a new version of the
      intervention. We will start with a 6-20 session adaptation of the Fairburn, Marcus, and
      Wilson (1993) CBT intervention, and modify it to fit an adolescent population. The
      development and revision process will be led by our core Expert Group of clinicians and
      researchers meeting weekly. We will be guided by the Expert Group's prior experiences
      developing and evaluating CBT for adult BN, and CBT for adolescent depression; and
      qualitative feedback from youth, parent, and provider stakeholders. In the second phase
      (months 19 to 32), we will conduct a larger pilot for the purpose of estimating effect size,
      using the stable, final version of the intervention. The pilot will enroll 50 adolescents and
      their families who are identified through their pediatric providers in the HMO or in response
      to a mass mailing of recruitment materials and a screening questionnaire. Half of the
      participants will be randomized to receive the intervention immediately upon enrollment and
      half (Wait List) to a treatment as usual followed by a delayed intervention 6 months after
      enrollment. Data will be collected through interviews with the teen and a parent at baseline,
      3 months, 6 months and for the Wait List teens, at 9 months and 12 months post enrollment.
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: binge eating; adolescent girls; cognitive behavioral therapy