Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder

NCT07212673 | Recruiting DMC

• 2 other identifiers: 20251574K23AT012126
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will evaluate the acceptability and feasibility of a 16-session digital mindfulness-based and cognitive behavioral therapy (CBT) intervention for binge eating disorder (BED) + coached self-monitoring vs. a coached self-monitoring intervention. This study is a pilot randomized controlled trial.

Conditions

Binge Eating Disorder

Keywords

binge eating; eating disorder; obesity

Outcome Measures

Primary Outcomes (2)

• Feasibility / Completion (questionnaire developed by our lab)

  Number of participants completing intervention

  From baseline to 2-month follow-up visit

• Acceptability

  Dimensions of usability from the System Usability Scale; single-items measuring dimensions of acceptability, including overall satisfaction, engagement, visual appeal of content, understandability of program content, desire to continue the program, perceived skill acquisition, perceived confidence in implementing skills, and perceived helpfulness. Scores for each item range from 1 to 5, with higher scores indicating better acceptability. Scores will be averaged to obtain acceptability ratings.

  After completing intervention, an average of 18-weeks

Study Arms (2)

CBT-based Mindful Courage + Coached Self-Monitoring

EXPERIMENTAL

CBT-based Mindful Courage is a digital intervention including mindfulness and CBT elements for individuals with binge eating disorder. It will consist of 16 self-guided modules. Elements included in the intervention include psychoeducation, self-monitoring, regular eating, goal-setting, weekly weighing, eating a sufficient amount of food at each meal, eating a range of foods reduction of overvaluation of weight and shape, addressing shape/body checking or avoidance, behavior chain analysis, problem solving, awareness and acceptance of binge eating urges, thoughts and emotions, values awareness, values clarification, values-based decision making, self-compassion, exploring needs underlying binge eating urges, mindful eating, hunger and fullness awareness, self-compassion, and self-care. Weekly mindfulness practice (at least 3x per week) is heavily emphasized. Participants will also be asked to self-monitor their food intake in Recovery Record and will receive phone coaching.

Behavioral: CBT-based Mindful Courage; Behavioral: Coached Self-Monitoring

Coached Self-Monitoring

ACTIVE COMPARATOR

Participants will be asked to self-monitor their food intake in Recovery Record and will receive phone coaching

Behavioral: Coached Self-Monitoring

Interventions

CBT-based Mindful Courage BEHAVIORAL

Self-guided online intervention

CBT-based Mindful Courage + Coached Self-Monitoring

Coached Self-Monitoring BEHAVIORAL

Participants will log meals in recovery record

CBT-based Mindful Courage + Coached Self-Monitoring; Coached Self-Monitoring

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or older
• ability to speak English fluently
• meeting DSM-5 criteria for current BED (i.e., in the past three months)
• willing and able to commit to the entire study protocol

You may not qualify if:

• a BMI below 18.5
• requiring immediate treatment for medical complications
• having current anorexia or bulimia nervosa or purging behaviors within the past year
• being pregnant or breast-feeding
• experiencing other severe psychopathology or medical illness that would limit the participants' ability to comply with the demands of the current study (e.g. active suicidal risk, active psychotic disorder, unmedicated bipolar disorder, severe substance use disorder, cancer)
• currently receiving BED or weight loss treatment (treatment for other conditions will be allowed, as long as the treatment is not mindfulness-based)
• currently taking medications for weight loss, or beginning medications that affect eating/weight within the last six months.

Sponsors & Collaborators

• Yeshiva University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Yeshiva University

The Bronx, New York, 10461, United States

RECRUITING

MeSH Terms

Conditions

Binge-Eating Disorder; Bulimia; Feeding and Eating Disorders; Obesity

Condition Hierarchy (Ancestors)

Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Central Study Contacts

Margaret Sala, Ph.D.

CONTACT

19723694267; margarita.sala@yu.edu

Hedy Kober, Ph.D.

CONTACT

9174708331; hedy@berkeley.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 8, 2025
• Study Start: November 2, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)