Bulimia NervosaNCT05770947
Cognitive Behavioral Therapy for Adolescents With Bulimia Nervosa and Higher Weight (Online Treatment Study)
A study testing Cognitive Behavioral Therapy and Mindfulness in people with Bulimia Nervosa and Overweight or Obesity, run by Yale University at 1 site in United States.
Trial summary
This study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa (binge eating and purging, or going to extremes to lose weight). Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Bulimia Nervosa, Overweight or Obesity
- What is being tested?
- Cognitive Behavioral Therapy and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2023to 27 Jun 2025
- Phase
- Interventional
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have higher weight (>85th BMI percentile or >85th percentile in past year)
- 2 binge/purge episodes per month for the prior 3 months
- Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
- Read, comprehend, and write English at a sufficient level to complete study-related materials;
- Provide an approval form from a healthcare provider;
- Provide a signed and dated written assent (or consent for youth age 18 or 19) prior to study participation;
- Provide a signed and dated written consent from one parent prior to study participation;
- Be available for participation in the study for 4 months.
Who cannot join
- Medical or psychiatric conditions requiring hospitalization or intensive care
- anorexia nervosa
- developmental or cognitive disorders that would interfere with therapy
- pregnancy or breastfeeding
- concurrent treatments (medication or psychological) influencing appetite or weight
- began hormone therapy in prior 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University (Teen Power - Online)
New Haven, Connecticut, 06520
About this study
This study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa (binge eating and purging, or going to extremes to lose weight).
Read the detailed description
This study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa. Bulimia nervosa is when individuals binge eat (overeat while feeling like they lost control) and purge (do something extreme or unhealthy to lose weight or prevent weight gain). Bulimia nervosa happens across different ages and body sizes. This study is focusing on adolescents who have a larger body size. Adolescents will receive treatment that is 4 months of 45-minute sessions, weekly. Treatment will occur over telehealth (e.g., zoom), and the whole study is online.
- Conditions
- Bulimia Nervosa, Overweight or Obesity
- Being tested
- Cognitive Behavioral Therapy, Mindfulness
- Medical subject headings
- Bulimia Nervosa, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Cognitive Behavioral Therapy (CBT) is a psychological treatment or "talk therapy" that integrates how people think, feel, and behave to create new behavior patterns that improve thinking processes and reduce distress.
MindfulnessBehavioural
Also called Learning to Breathe
Mindfulness is a psychological treatment or "talk therapy" that practices different coping skills to improve thinking processes and reduce distress.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Cognitive Behavioral Therapy for adolescents with higher weight seeking treatment for bulimia nervosa (CBT-BNh).Designed for adolescents, CBT-BNh will include psychoeducation, cognitive restructuring, and relapse prevention planning. The focus of therapy will include reducing extreme/unhealthy weight-control behaviors (purging) as well as binge eating, and self-compassion coping skills will address weight stigma and self-directed weight criticism. Receives: Behavioral: Cognitive Behavioral Therapy |
| Mindfulness | Active comparator | Learning to Breathe (L2B) is an existing, evidence-based program for adolescents that teaches mindfulness skills each week, including time to practice and reflect. the skills are grouped into six themes: Body, Reflections, Emotions, Attention, Tenderness, Habits, and Empowerment. Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bulimia nervosa remission assessed by the Eating Disorder Examination Questionnaire (EDE-Q)
Remission from binge eating and purging behaviors will be assessed by EDE-Q. The EDE-Q is a self-report questionnaire with four subscales and a global severity score. the global score ranges from 0-6 with higher scores reflecting greater severity of eating disorder behaviors.
Measured: baseline and post-treatment (Month 4)
Secondary outcomes (5)
Change in Binge eating frequency assessed by the EDE-Q
Number of episodes of binge eating in past month
Measured: baseline and post-treatment (Month 4)
Change in Purging frequency assessed by the EDE-Q
Number of episodes of purging in past month
Measured: baseline and post-treatment (Month 4)
Change in eating disorder psychopathology assessed by the Eating Disorder Examination Questionnaire (EDE-Q) global score.
Eating disorder psychopathology will be assessed using the EDE-Q global score. The EDE-Q is a self-report questionnaire with four subscales and a global severity score. the global score ranges from 0-6 with higher scores reflecting greater severity of eating disorder psychopathology.
Measured: baseline and post-treatment (Month 4)
Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
Depression will be assessed using the PHQ-9. PHQ-9 is a validated questionnaire used to screen for depression with a range of scores from 0-27. Higher scores indicate more severe depressive symptoms.
Measured: baseline and post-treatment (Month 4)
Change in Self-esteem assessed using the Rosenberg Self-Esteem Scale (RSES)
Self-esteem will be assessed using the RSES. The RSES is a self-report measure that consists of 10 statements related to overall feelings of self-worth or self-acceptance. The items are answered on a four-point scale ranging from strongly agree to strongly disagree. The total score ranges from 0 to 30 with higher scores indicating higher self esteem.
Measured: baseline and post-treatment (Month 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start24 Jan 2023
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
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 Yale UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eating Disorders Association
- Responsible party
- Sponsor
- Investigators
- Janet A Lydecker, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770947
- Sponsor's protocol ID
- 2000033150
- Status last verified
- Dec 2025
- First submitted
- 3 Mar 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because of the sensitive nature of these data, IPD sharing will be limited to requests from other researchers that are reasonable and accompanied by an approved protocol.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Adolescents With Bulimia Nervosa and Higher Weight (Online Treatment Study)
- ClinicalTrials.gov ID
- NCT05770947
- Acronym / sponsor ID
- 2000033150
- Conditions
- Bulimia Nervosa, Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Eating Disorders Association
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 16 Mar 2023 (actual)
- 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.
This study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa (binge eating and purging, or going to extremes to lose weight).
Detailed description
This study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa. Bulimia nervosa is when individuals binge eat (overeat while feeling like they lost control) and purge (do something extreme or unhealthy to lose weight or prevent weight gain). Bulimia nervosa happens across different ages and body sizes. This study is focusing on adolescents who have a larger body size. Adolescents will receive treatment that is 4 months of 45-minute sessions, weekly. Treatment will occur over telehealth (e.g., zoom), and the whole study is online.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy for adolescents with higher weight seeking treatment for bulimia nervosa (CBT-BNh).Designed for adolescents, CBT-BNh will include psychoeducation, cognitive restructuring, and relapse prevention planning. The focus of therapy will include reducing extreme/unhealthy weight-control behaviors (purging) as well as binge eating, and self-compassion coping skills will address weight stigma and self-directed weight criticism. |
| Mindfulness | Active comparator | Behavioral: MindfulnessLearning to Breathe (L2B) is an existing, evidence-based program for adolescents that teaches mindfulness skills each week, including time to practice and reflect. the skills are grouped into six themes: Body, Reflections, Emotions, Attention, Tenderness, Habits, and Empowerment. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Have higher weight (>85th BMI percentile or >85th percentile in past year)
- 2 binge/purge episodes per month for the prior 3 months
- Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
- Read, comprehend, and write English at a sufficient level to complete study-related materials;
- Provide an approval form from a healthcare provider;
Key exclusion criteria (6 listed)
- Medical or psychiatric conditions requiring hospitalization or intensive care
- anorexia nervosa
- developmental or cognitive disorders that would interfere with therapy
- pregnancy or breastfeeding
- concurrent treatments (medication or psychological) influencing appetite or weight
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 TherapyCognitive Behavioral Therapy (CBT) is a psychological treatment or "talk therapy" that integrates how people think, feel, and behave to create new behavior patterns that improve thinking processes and reduce distress. | Behavioural | Cognitive Behavioral Therapy |
| MindfulnessAlso: Learning to BreatheMindfulness is a psychological treatment or "talk therapy" that practices different coping skills to improve thinking processes and reduce distress. | Behavioural | Mindfulness |
Primary outcome
Change in Bulimia nervosa remission assessed by the Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: baseline and post-treatment (Month 4)
Remission from binge eating and purging behaviors will be assessed by EDE-Q. The EDE-Q is a self-report questionnaire with four subscales and a global severity score. the global score ranges from 0-6 with higher scores reflecting greater severity of eating disorder behaviors.
5 secondary outcomes
Change in Binge eating frequency assessed by the EDE-Q
Time frame: baseline and post-treatment (Month 4)
Change in Purging frequency assessed by the EDE-Q
Time frame: baseline and post-treatment (Month 4)
Change in eating disorder psychopathology assessed by the Eating Disorder Examination Questionnaire (EDE-Q) global score.
Time frame: baseline and post-treatment (Month 4)
Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
Time frame: baseline and post-treatment (Month 4)
Change in Self-esteem assessed using the Rosenberg Self-Esteem Scale (RSES)
Time frame: baseline and post-treatment (Month 4)
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 18 Dec 2025.
- Individual participant dataSharing planned: No. Because of the sensitive nature of these data, IPD sharing will be limited to requests from other researchers that are reasonable and accompanied by an approved protocol.
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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.
Janet A Lydecker, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Mindfulness in people with Bulimia Nervosa and Overweight or Obesity, run by Yale University 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 8 inclusion and 6 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 18 Dec 2025. 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.
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?
Change in Bulimia nervosa remission assessed by the Eating Disorder Examination Questionnaire (EDE-Q) (time frame: baseline and post-treatment (Month 4)). 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 18 Dec 2025.