Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy (CBT-MM) for Binge Eating Disorder

NCT06604299 | Completed DMC

• 2 other identifiers: 127265K23AT012126
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will evaluate the acceptability and feasibility of a 18-week long digital mindfulness-based and cognitive behavioral therapy intervention for binge eating disorder. This study is a prospective single-arm trial during the intervention development phase. Following this phase, after the intervention has been further developed, a subsequent study (with a different clinicaltrials.gov identification #) will utilize a randomized control trial design.

Conditions

Binge Eating Disorder

Keywords

binge eating; eating disorders; obesity

Outcome Measures

Primary Outcomes (2)

• Acceptability

  Single-items measuring dimensions of acceptability, including overall satisfaction, engagement, visual appeal of content, understandability of program material, desire to continue the program, and overall helpfulness. Scores for each item range from 1 to 5, , with higher scores indicating better acceptability.

  18-week treatment period

• Feasibility/Completion

  Module completion, ranging from 0 to 100%

  18-week treatment period

Secondary Outcomes (7)

• Changes in Emotion Dysregulation

  Baseline to post-treatment (18-weeks)

• Changes in Mindfulness

  Baseline to post-treatment (18-weeks)

• Changes in Objective Binge Eating Episodes

  Baseline to post-treatment (18-weeks)

• Change in Body Mass Index (BMI)

  Baseline to post-treatment (18-weeks)

• Changes in Dietary Restraint

  Baseline to post-treatment (18-weeks)

Study Arms (1)

Digital CBT-MM

EXPERIMENTAL

Digital CBT-MM is a digital intervention including mindfulness and cognitive behavioral elements for individuals with binge eating disorder. Mindful Courage will consist of 18-weeks of 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 (including foods that patients may fear), 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.

Behavioral: Meditation-enhanced Cognitive Behavioral Therapy

Interventions

Meditation-enhanced Cognitive Behavioral Therapy BEHAVIORAL

Self-guided online intervention

Digital CBT-MM

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• Meeting DSM-5 criteria for Binge Eating Disorder (BED)
• English-speaking

You may not qualify if:

• BMI \< 18.5
• Requiring immediate treatment for medical complications
• Current anorexia or bulimia nervosa or purging behaviors within the past year
• Already receiving treatment for an ED or participating in a weight loss program or psychotherapy focused on weight (psychotherapy for other conditions was allowed)
• Currently 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 psychotic disorder, cancer)

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

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)