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Cognitive Behavioral Therapy to Treat Bulimia Nervosa in Adolescents

Development of CBT Model for Adolescent Bulimia Nervosa

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00522769
Acronym
claire
Enrollment
26
Registered
2007-08-30
Start date
2005-09-30
Completion date
2009-05-31
Last updated
2010-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bulimia Nervosa

Keywords

binge eating, adolescent girls, cognitive behavioral therapy

Brief 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.

Interventions

BEHAVIORALCognitive Behavioral Therapy

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

Sponsors

Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 18 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
: changes in other psychiatric symptomatology and6 months
associated adaptive functioning and eating concerns6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026