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

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

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.

Study Overview

• Status: Completed
• Conditions: Binge Eating Disorder
• Intervention / Treatment: Behavioral: Meditation-enhanced Cognitive Behavioral Therapy

Detailed Description

Procedures include completing: (1) pre-intervention screening assessment; (2) an initial baseline visit; (3) 18-week web-based intervention; and (4) a post-intervention assessment (18-weeks after baseline).

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10461
      • Yeshiva University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Digital CBT-MM; 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; Self-guided online intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Emotion Dysregulation	Difficulties in Emotion Regulation Short Form (DERS-SF). Total scores are the average of each of the subscales, and range from 1 to 5. Higher scores indicate more emotion dysregulation	Baseline to post-treatment (18-weeks)
Changes in Mindfulness	Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness.	Baseline to post-treatment (18-weeks)
Changes in Objective Binge Eating Episodes	Eating Disorder Examination-Questionnaire (EDE-Q). The EDE-Q asks participants to report on the number of episodes in the last 28 days in which they ate a large amount of food with a sense of loss of control.	Baseline to post-treatment (18-weeks)
Change in Body Mass Index (BMI)	Computed using self-reported height and body weight	Baseline to post-treatment (18-weeks)
Changes in Dietary Restraint	Dietary restraint subscale of the EDE-Q (EDE-Q; Fairburn & Beglin, 1994). Scores range from 0 to 6, and higher scores indicate higher restraint.	Baseline to post-treatment (18-weeks)
Changes in Quality of Life	Eating Disorder Quality of Life scale (EDQOL; Engel et al., 1996). Scores on each item range from 1 to 4, with higher scores indicating better quality of life.	Baseline to post-treatment (18-weeks)
Changes in Depression Symptoms	Beck Depression Inventory-II (BDI-II; Beck et al., 1996). Scores range from 0 to 63, with higher scores indicating higher depression symptoms.	Baseline to post-treatment (18-weeks)

Collaborators and Investigators

• Sponsor: Yeshiva University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: obesity; eating disorders; binge eating
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Hyperphagia; Signs and Symptoms, Digestive; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Bulimia; Obesity; Binge-Eating Disorder; Feeding and Eating Disorders
• Other Study ID Numbers: 127265; K23AT012126 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No