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Completed

NCT Number: NCT05770947

Cognitive Behavioral Therapy for Adolescents With Bulimia Nervosa and Higher Weight (Online Treatment 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).

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Key information

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University (Teen Power - Online)

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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.

Mindfulness

Behavioral

Mindfulness is a psychological treatment or "talk therapy" that practices different coping skills to improve thinking processes and reduce distress.

Other names: Learning to Breathe

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Binge eating frequency assessed by the EDE-Q

    Time frame: baseline and post-treatment (Month 4)

    Number of episodes of binge eating in past month

  2. Change in Purging frequency assessed by the EDE-Q

    Time frame: baseline and post-treatment (Month 4)

    Number of episodes of purging in past month

  3. Change in eating disorder psychopathology assessed by the Eating Disorder Examination Questionnaire (EDE-Q) global score.

    Time frame: baseline and post-treatment (Month 4)

    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.

  4. Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)

    Time frame: baseline and post-treatment (Month 4)

    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.

  5. Change in Self-esteem assessed using the Rosenberg Self-Esteem Scale (RSES)

    Time frame: baseline and post-treatment (Month 4)

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Eating Disorders Association

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2023
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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