Binge Eating Self-help for Teens ONLINE Pilot and Feasibility Study

Not Applicable

Active, not recruiting

• Conditions: Binge-Eating Disorder; Binge Eating; Overweight or Obesity
• Interventions: Behavioral: Binge Eating Self-help for Teens

• Registration Number: NCT06107387
• Lead Sponsor: Yale University

Brief Summary

This study is a pilot clinical trial of a new guided self-help CBT for binge eating. Participants will complete an intake assessment; following determination of eligibility, participants will then complete four months of treatment (weekly guided self-help sessions). At the end of treatment, participants will complete an interview with a research clinician to assess outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-30
• Study Start: 2024-02-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

To be included, adolescents must:

1. Be in the age range ≥12 years old and ≤17 years old;
2. Have a BMI that places them above the 85th percentile based on their age and sex;
3. Report 2 episodes of binge/LOC eating (feeling a loss of control while eating) per month for the past 3 months;
4. Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
5. Read, comprehend, and write English at a sufficient level to complete study-related materials;
6. Provide a signed and dated written assent prior to study participation;
7. Provide a signed and dated written consent from one parent prior to study participant; and
8. Be available for participation in the study for 4 months.

Exclusion Criteria

Prospective participants will be excluded if the adolescent:

1. Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., neurological disorder, psychotic disorders, suicidality);
2. Has a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems);
3. Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
4. Is pregnant or breastfeeding;
5. Is taking medication(s) or participating in treatment(s) that could influence weight or appetite;
6. Began taking hormonal contraceptives less than 3 months prior;
7. Has a developmental or cognitive disorder (e.g., autism spectrum disorder);
8. Has a concurrent feeding/eating disorder (e.g., bulimia nervosa); or
9. Is participating in another clinical research study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Binge Eating Self-help for Teens	Binge Eating Self-help for Teens	Participants will have 16 guided self-help sessions (4 months; weekly sessions for adolescents with parents joining monthly). Participants will complete daily self-monitoring of eating behaviors (timing of meals and snacks; whether or not a binge occurred) throughout treatment. Treatment sessions involve a self-help component, which includes brief videos that participants watch at home. Treatment sessions also involve a guidance component (brief consultation), which is 15-30 minutes on a secure videoconferencing platform (e.g., Zoom) between the therapist and the participant. These sessions focus on clarifying material, reviewing self-monitoring and looking for patterns, and problem-solving maladaptive thinking patterns and binge behaviors.

Primary Outcome Measures

Name	Time	Method
Attendance	4 months	Number of participants attending \>75% of sessions
Retention	4 months	Number of participants who attend through the end of treatment

Secondary Outcome Measures

Name	Time	Method
Treatment Satisfaction	4 months	Adolescent/parent/clinician treatment satisfaction (acceptable or higher, Client Satisfaction Questionnaire)
Treatment Credibility	1 week	Adolescent/parent treatment credibility (moderate or higher, study-specific face-valid treatment credibility form)

Trial Locations

Locations (1)

Yale; 🇺🇸 New Haven, Connecticut, United States