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

NCT05770947 | Completed

• 1 other identifier: 2000033150
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Overweight or Obesity; Bulimia Nervosa

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and post-treatment (Month 4)

Secondary Outcomes (5)

• Change in Binge eating frequency assessed by the EDE-Q

  baseline and post-treatment (Month 4)

• Change in Purging frequency assessed by the EDE-Q

  baseline and post-treatment (Month 4)

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

  baseline and post-treatment (Month 4)

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

  baseline and post-treatment (Month 4)

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

  baseline and post-treatment (Month 4)

Study Arms (2)

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.

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.

Behavioral: Mindfulness

Interventions

Mindfulness BEHAVIORAL

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

Also known as: Learning to Breathe

Mindfulness

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.

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Have higher weight (\>85th BMI percentile or \>85th percentile in past year)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Eating Disorders Association: collaborator

Study Sites (1)

Yale University (Teen Power - Online)

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Bulimia Nervosa; Overweight; Obesity

Interventions

Cognitive Behavioral Therapy; Mindfulness

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Janet A Lydecker, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 16, 2023
• Study Start: January 24, 2023
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)