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Clinical Trials/NCT05770947
NCT05770947CompletedNot Applicable

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

Yale University1 site in 1 country25 target enrollmentStarted: January 24, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
1
Primary Endpoint
Change in Bulimia nervosa remission assessed by the Eating Disorder Examination Questionnaire (EDE-Q)

Study Overview

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).

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to 19 Years (Child, Adult)
Sex
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

Arms & Interventions

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.

Intervention: Cognitive Behavioral Therapy (Behavioral)

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.

Intervention: Mindfulness (Behavioral)

Outcomes

Primary Outcomes

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

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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