Digital cognitive-behavioral therapy plus mindfulness for binge eating
Official title: Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder: a Feasibility Randomized Controlled Trial
Run by Yeshiva University · NCT07212673 · Data updated 2026-11-12
This pilot will test whether a 16-session guided digital program combining CBT and mindfulness with coaching helps adults with binge eating disorder more than coached self-monitoring.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Yeshiva University Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Status | Recruiting |
| Started | November 2, 2025 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | November 4, 2025 |
| Trial ID | NCT07212673 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ who meet DSM-5 criteria for current binge eating disorder, speak English, have BMI ≥ 18.5, are not pregnant or receiving current BED/weight-loss treatment, and can commit to all study visits are ideal candidates.
✕Probably not a fit
People with active anorexia or bulimia, recent purging, severe unmanaged psychiatric or medical conditions (e.g., active suicidal ideation, psychosis, unmedicated bipolar disorder), BMI < 18.5, pregnancy/breastfeeding, or recent use of weight-loss medications are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot randomized controlled trial compares a 16-session digital mindfulness-based and cognitive behavioral therapy program (Mindful Courage) plus coaching to a coached self-monitoring intervention in adults meeting DSM-5 criteria for binge eating disorder. Participants complete a pre-screening, an initial baseline visit, the assigned digital intervention with coaching, a mid-study visit, a post-intervention assessment about 18 weeks after baseline, and a 2-month follow-up. The primary aims are to examine acceptability and feasibility, with clinical measures such as binge frequency collected as outcome data. Key exclusions include current anorexia or bulimia, recent purging, severe unmanaged psychiatric or medical conditions, pregnancy/breastfeeding, BMI < 18.5, and current BED or weight-loss treatment or recent weight-affecting medications.
Why it matters
Potential benefit: If successful, this program could provide an accessible coached digital option that reduces binge-eating episodes and teaches lasting coping skills.
How similar studies have gone: Cognitive behavioral therapy and mindfulness each have evidence for reducing binge eating and digital delivery has promising pilot data, but a coached digital program that combines both approaches remains relatively novel and is being piloted here.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Yeshiva University
The Bronx, New York, United States Recruiting
Study contacts
- Study coordinator: Margaret Sala, Ph.D.
- Email: margarita.sala@yu.edu
- Phone: 19723694267
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.