Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 19, 2026
Date Accepted: Mar 11, 2026
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Combining Digital Cognitive-Behavior Therapy with Mindfulness Training for Binge Eating Disorder: A Trial Protocol
ABSTRACT
Background:
Cognitive behavioral therapy (CBT) is the most effective treatment for binge eating disorder (BED) but is limited by modest efficacy and low reach of in-person delivery. Combining mindfulness training with CBT could enhance efficacy by targeting emotion dysregulation, a key factor in BED that CBT does not adequately target. Digital delivery can enhance the reach of treatment. Accordingly, we developed CBT-based Mindful Courage, a 16-session digital intervention combining CBT and mindfulness training for BED.
Objective:
To conduct a pilot randomized controlled trial to evaluate the feasibility (intervention completion, assessment completion) and acceptability (usability, 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) of CBT-based Mindful Courage. We will also evaluate changes in outcomes (binge eating frequency, eating disorder symptoms, clinical impairment, depression symptoms), and mechanisms (emotion dysregulation, dietary over-restriction, trait mindfulness).
Methods:
This is a parallel-group, single-blinded, randomized controlled trial with a 1:1 allocation ratio. It will be conducted from October 2025 to October 2026, with study assessments at baseline, mid-treatment, end-of-treatment, and 2-month follow-up. We will recruit a volunteer sample of adults with BED (N=40) aged 18-75 via online ads. Exclusionary criteria include a BMI below 18.5, current anorexia or bulimia nervosa, and current treatment for BED or weight loss. Participants will be randomly allocated to an active control that includes coached self-monitoring (CSM; self-monitoring of food intake in Recovery Record and coaching calls by a research assistant) or to CBT-based Mindful Courage + CSM. Both conditions will have a duration of 18 weeks. All study sessions will take place over Zoom.
Results:
Findings will be published in a peer-reviewed journal following study completion.
Conclusions:
This will be an important first step in creating a scalable and efficacious treatment for BED. Clinical Trial: ClinicalTrials.gov identifier: NCT07212673
Citation
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