Combining Digital Cognitive Behavioral Therapy With Mindfulness Training for Binge Eating Disorder: Protocol for a Feasibility Trial.
Margaret Sala, Corey Roos, Dante Ascarrunz...
https://pubmed.ncbi.nlm.nih.gov/42061840/Actively Recruiting
Led by Yeshiva University · Updated on 2025-11-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating a 16-session digital program combining mindfulness and cognitive behavioral therapy CBT to help people with binge eating disorder BED. This pilot randomized controlled trial compares this combined intervention plus coached self-monitoring to coached self-monitoring alone. The study aims to assess how acceptable and feasible these approaches are for participants. The experimental group uses the CBT-based Mindful Courage digital program, which includes self-guided modules covering psychoeducation, self-monitoring, regular eating habits, goal setting, mindful eating, self-compassion, and values-based decision making. Participants practice mindfulness at least three times a week and receive phone coaching while logging their food intake in the Recovery Record app. The comparison group receives coached self-monitoring, including meal logging and phone coaching. Participants will complete a screening assessment, a baseline visit, the assigned intervention over about 18 weeks, a mid-study visit, a post-intervention assessment approximately 18 weeks after baseline, and a 2-month follow-up. Researchers will measure feasibility and acceptability using questionnaires during and after the intervention. The total participation duration spans from baseline through the follow-up assessment to monitor outcomes and participant experiences.
CONDITIONS
Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder
M
Margaret Sala, Ph.D.
H
Hedy Kober, Ph.D.
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Yeshiva University
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | CBT‑based Mindful Courage + Coached Self‑Monitoring | Coached Self‑Monitoring Alone | Eating‑Disorder‑Focused CBT (Standard of Care) |
|---|---|---|---|
| What it is | A digital cognitive‑behavioral therapy programme enhanced with mindfulness training combined with coached self‑monitoring sessions. | A behavioural intervention where participants log meals using a coached self‑monitoring tool. | Eating‑disorder‑focused cognitive‑behavioral therapy in individual or group format is recommended first‑line treatment for binge‑eating disorder. |
| What role it plays in the study | Experimental intervention combining digital CBT and mindfulness plus self‑monitoring. | Active comparator representing self‑monitoring with coaching only. | Serves as a benchmark of current guideline‑recommended treatment not included in the trial arms. |
| Primary use | To evaluate if adding mindfulness training to digital CBT plus coached self‑monitoring improves feasibility and acceptability in BED. | Acts as baseline behavioural intervention of self‑monitoring with coaching for comparison. | Represents the established psychological therapy recommended for addressing binge‑eating disorder. |
| How it is given or performed | Delivered online with mindfulness modules and coaching support for self‑monitoring. | Delivered via meal‑logging in Recovery Record with coaching support. | Typically delivered by trained therapists in individual or group sessions. |
| Evidence status | Feasibility and acceptability being evaluated; clinical efficacy not yet established. | Established as behavioural support but not validated as standalone BED treatment in guidelines. | Proven effective psychotherapy for binge‑eating disorder across multiple studies and guidelines. |
| Important limitations | Efficacy has not been demonstrated; results may not generalize beyond feasibility sample. | Comparator may not reflect full therapeutic effect as mindfulness component is omitted. | Not tested within this trial; mode of delivery (digital vs therapist‑led) may differ from trial interventions. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for pre-intervention screening assessment
Duration - 1 day
Participants complete an initial baseline visit before starting the assigned intervention.
1 baseline visit (in-person or remote)
Duration - Approximately 18 weeks
Participants undergo their assigned behavioral intervention, including self-guided digital cognitive-behavior therapy, mindfulness training, and/or coached self-monitoring.
Weekly self-guided modules and coaching contacts with a mid-study visit
Duration - 1 day
Participants complete assessments after finishing the intervention to evaluate outcomes.
1 post-intervention visit approximately 18 weeks after baseline
Duration - 2 months
Participants complete a follow-up assessment two months after the post-intervention visit to monitor ongoing outcomes.
1 follow-up visit
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Margaret Sala, Corey Roos, Dante Ascarrunz...
https://pubmed.ncbi.nlm.nih.gov/42061840/Yeshiva University
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor