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

NCT ID: NCT06107387

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-14
• Study Completion Date: 2025-06-26

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.

Conditions

Binge Eating; Binge-Eating Disorder; Overweight or Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Binge Eating Self-help for Teens

Intervention Type: BEHAVIORAL

Guided self-help intervention

Interventions

Binge Eating Self-help for Teens

Guided self-help intervention

Intervention Type: BEHAVIORAL

Other Intervention Names

BEST

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janet A Lydecker, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

000

Identifier Type: OTHER

Identifier Source: secondary_id

2000033103

Identifier Type: -

Identifier Source: org_study_id