NCT00522769

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

February 15, 2010

Status Verified

February 1, 2010

Enrollment Period

3.7 years

First QC Date

August 29, 2007

Last Update Submit

February 12, 2010

Conditions

Bulimia Nervosa

Keywords

binge eatingadolescent girlscognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • : changes in other psychiatric symptomatology and

    6 months

  • associated adaptive functioning and eating concerns

    6 months

Study Arms (2)

Delayed Intervention

ACTIVE COMPARATOR

1/2 of participants are randomized to immediate intervention that starts within a week of randomization. The other 1/2 of the participants are randomized to delayed intervention which starts 6 months after randomization.

Behavioral: Cognitive Behavioral Therapy

Immediate intervention

EXPERIMENTAL

Immediate intervention starts within two weeks of randomization. Delayed interventions starts 6 months after randomization.

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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

Delayed InterventionImmediate intervention

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 12-18, inclusive.
  • Female
  • A DSM-IV diagnosis of current BN or spectrum BN
  • One or both parent(s) willing to participate in study assessments and intervention visit

You may not qualify if:

  • A current DSM-IV diagnosis of AN.
  • A DSM-IV diagnosis of a psychotic disorder (current or past).
  • Current or past cognitive behavior therapy for an eating disorder or other mental health condition
  • Currently receiving antidepressant medication or medications known to impact weight
  • A significant organic brain syndrome, mental retardation, pervasive developmental disorder or autism.
  • Current pregnancy.
  • Current treatment specifically for ED (not counting medical case management).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Bulimia NervosaBulimia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lynn L DeBar, PhD MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 30, 2007

Study Start

September 1, 2005

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

February 15, 2010

Record last verified: 2010-02

Locations

US(1)