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).

Study Overview

• Status: Recruiting
• Conditions: Bulimia Nervosa; Overweight or Obesity
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Behavioral: Mindfulness

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janet A Lydecker, PhD; Phone Number: 203-785-7210; Email: janet.lydecker@yale.edu
• Study Contact Backup: Name: Teen Power; Phone Number: 203-785-7210; Email: teenpower@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University (Teen Power - Online)
      • Contact: Janet Lydecker, Phd; Phone Number: 203-737-4299; Email: janet.lydecker@yale.edu
      • Contact: Teen Power; Phone Number: 2037857210; Email: teenpower@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Binge eating frequency assessed by the EDE-Q	Number of episodes of binge eating in past month	baseline and post-treatment (Month 4)
Change in Purging frequency assessed by the EDE-Q	Number of episodes of purging in past month	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.	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.	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.	baseline and post-treatment (Month 4)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Eating Disorders Association
• Investigators: Principal Investigator: Janet A Lydecker, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Overnutrition; Nutrition Disorders; Body Weight; Hyperphagia; Bulimia; Overweight; Bulimia Nervosa
• Other Study ID Numbers: 2000033150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No