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

Not Applicable

Not yet recruiting

• Conditions: Binge Eating Disorder

• Registration Number: NCT07212673
• Lead Sponsor: Yeshiva University

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.

Detailed Description

Procedures include completing: (1) pre-intervention screening assessment; (2) an initial baseline visit; (3) the assigned intervention; (4) a mid-study visit; (5) a post-intervention assessment (\~18-weeks after baseline); and (6) a 2-month follow-up assessment.

Study Timeline

• Study First Submitted: 2025-09-17
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study Start: 2025-10-05
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility / Completion (questionnaire developed by our lab)	From baseline to 2-month follow-up visit	Number of participants completing intervention
Acceptability	After completing intervention, an average of 18-weeks	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.