Combining Digital Cognitive Behavioral Therapy With Mindfulness Training for Binge Eating Disorder: Protocol for a Feasibility Trial
Margaret Sala, Corey Roos, Dante Ascarrunz, Casey M Stern, Jonathan B Bricker, Jonathan M Feldman, Cheri Levinson, Mihaela Aslan, Jennifer L Hay, Hedy Kober
JMIR Research Protocols April 17, 2026 DOI: 10.2196/91761 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol Peer reviewed |
|---|---|
| Sample size | 40 |
| Population | Adults aged 18 to 75 years with binge eating disorder, recruited via online advertisements |
| Interventions | CBT-based Mindful Courage coached self-monitoring |
| Duration | 18-week intervention, with assessments at baseline, midtreatment, end-of-treatment, and 2-month follow-up |
| Topics | Meditation |
| Registration | NCT07212673 |
| Key findings | The authors propose that combining mindfulness training with CBT in a digital format could improve treatment for binge eating disorder by targeting emotion dysregulation, a factor they argue CBT does not adequately address. The pilot trial will test feasibility and acceptability, and explore changes in binge eating frequency, eating disorder symptoms, clinical impairment, depression, and proposed mechanisms including emotion dysregulation, dietary overrestriction, and trait mindfulness. |
Abstract
BackgroundCognitive 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. ObjectiveThe aim of this study is to conduct a pilot randomized controlled trial to evaluate the feasibility (intervention and 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, and depression symptoms) and mechanisms (emotion dysregulation, dietary overrestriction, and trait mindfulness). MethodsThis is a parallel-group, single-blinded, randomized controlled trial with a 1:1 allocation ratio. It will be conducted from November 2025 to November 2026, with study assessments at baseline, midtreatment, end-of-treatment, and 2-month follow-up. We will recruit a volunteer sample of adults with BED (N=40) aged 18 to 75 years via online advertisements. Exclusion criteria include a BMI <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 (self-monitoring of food intake in Recovery Record and coaching calls by a research assistant) or to CBT-based Mindful Courage+coached self-monitoring. Both conditions will have a duration of 18 weeks. All study sessions will take place over Zoom. ResultsThe study was funded in April 2023. Data collection began in November 2025, and we anticipate recruitment to be completed by November 2026. Results are expected to be analyzed by May 2027 and published by May 2028. ConclusionsThis will be an important first step in creating a scalable and efficacious treatment for BED. Trial RegistrationClinicalTrials.gov NCT07212673; https://clinicaltrials.gov/study/NCT07212673 International Registered Report Identifier (IRRID)DERR1-10.2196/91761
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 5
- How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective Perspectives on Psychological Science October 14, 2011
- What defines mindfulness-based programs? The warp and the weft Psychological Medicine December 29, 2016
- Combining Cognitive-Behaviour Therapy With Mindfulness Training in a Digital Intervention for Binge Eating Disorder: A Single-Session Pilot Trial. European Eating Disorders Review May 11, 2025
- Mechanisms of Mindfulness Training: Monitor and Acceptance Theory (MAT) Clinical Psychology Review November 5, 2016
- Effectiveness of online mindfulness-based interventions in improving mental health: A review and meta-analysis of randomised controlled trials. Clinical Psychology Review April 1, 2016