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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- Being tested
- Cognitive Behavioral Therapy
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral Therapy |
| Immediate intervention | Experimental | Immediate 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.
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)
: changes in other psychiatric symptomatology and
Measured: 6 months
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.
- First posted30 Aug 2007 (estimated)
- Study startSep 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Investigators
- Lynn L DeBar, PhD MPH, Principal investigator, Kaiser Permanente
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of CBT Model for Adolescent Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT00522769
- Acronym / sponsor ID
- claire / 5R34MH073796
- Conditions
- Bulimia Nervosa
- Keywords
- binge eating, adolescent girls, cognitive behavioral therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 30 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Intervention | Active comparator | Behavioral: Cognitive Behavioral Therapy1/2 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. |
| Immediate intervention | Experimental | Behavioral: Cognitive Behavioral TherapyImmediate intervention starts within two weeks of randomization. Delayed interventions starts 6 months after randomization. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyGirls 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 | Behavioural | Delayed Intervention, Immediate intervention |
Primary outcome
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
2 secondary outcomes
: changes in other psychiatric symptomatology and
Time frame: 6 months
associated adaptive functioning and eating concerns
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn L DeBar, PhD MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
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.