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

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05770947
Collaborator
National Eating Disorders Association (Other)
40
1
2
35.2
1.1

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy
  • Behavioral: Mindfulness
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Cognitive Behavioral Therapy for Adolescents With Bulimia Nervosa and Higher Weight (Online Treatment Study)
Actual Study Start Date :
Jan 24, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cognitive Behavioral Therapy

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.

Behavioral: Cognitive Behavioral Therapy
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.

Active Comparator: Mindfulness

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.

Behavioral: Mindfulness
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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Bulimia nervosa remission assessed by the Eating Disorder Examination Questionnaire (EDE-Q) [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 Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 19 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale University (Teen Power - Online) New Haven Connecticut United States 06520

    Sponsors and Collaborators

    • Yale University
    • National Eating Disorders Association

    Investigators

    • Principal Investigator: Janet A Lydecker, PhD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT05770947
    Other Study ID Numbers:
    • 2000033150
    First Posted:
    Mar 16, 2023
    Last Update Posted:
    Mar 16, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 16, 2023