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Bulimia NervosaPhase 1/2claireNCT00522769

Cognitive Behavioral Therapy to Treat Bulimia Nervosa in Adolescents

A Phase 1/2 study testing Cognitive Behavioral Therapy in people with Bulimia Nervosa, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years, women only
Conditions the study is for
Bulimia Nervosa
What is being tested?
Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
Sep 2005to May 2009
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Kaiser Permanente Center for Health Research

    Portland, Oregon, 97227

Other trials in United States

About this study

Official title: Development of CBT Model for Adolescent Bulimia Nervosa

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).

Read the 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.

Conditions
Bulimia Nervosa
Keywords
binge eating, adolescent girls, cognitive behavioral therapy
Medical subject headings
Bulimia Nervosa, Bulimia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral TherapyBehavioural

    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

Study groups in NCT00522769
Study groupRoleWhat they receive
Delayed InterventionActive comparator1/2 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.
Receives: Behavioral: Cognitive Behavioral Therapy
Immediate interventionExperimentalImmediate intervention starts within two weeks of randomization. Delayed interventions starts 6 months after randomization.
Receives: Behavioral: Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 6 months

Secondary outcomes (2)
  1. : changes in other psychiatric symptomatology and

    Measured: 6 months

  2. associated adaptive functioning and eating concerns

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2007 (estimated)
  2. Study startSep 2005
  3. Primary completionMay 2009
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00522769
Sponsor's protocol ID
5R34MH073796
Acronym
claire
Status last verified
Feb 2010
First submitted
29 Aug 2007
Last updated
15 Feb 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cognitive Behavioral Therapy in people with Bulimia Nervosa, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery from ED (abstinence of all binging and purging during past 28 indices of binge eating, purging, and scores on the EDE-Q5 scale). (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2010.

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