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/42061840Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07212673
Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder: a Feasibility Randomized Controlled Trial
Led by Yeshiva University · Updated on 2025-11-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yeshiva University
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to speak English fluently
- Meeting DSM-5 criteria for current binge eating disorder within the past three months
- Willing and able to commit to the entire study protocol
You will not qualify if you...
- Body mass index (BMI) below 18.5
- Requiring immediate treatment for medical complications
- Current anorexia nervosa, bulimia nervosa, or purging behaviors within the past year
- Pregnant or breastfeeding
- Experiencing severe psychiatric or medical illness limiting study participation (e.g., active suicidal risk, psychotic disorder, unmedicated bipolar disorder, severe substance use disorder, cancer)
- Currently receiving treatment for binge eating disorder or weight loss
- Taking medications for weight loss or started medications affecting eating/weight within the last six months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
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
Baseline
Duration - 1 day
Participants complete an initial baseline visit before starting the assigned intervention.
1 baseline visit (in-person or remote)
Treatment
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
Post-intervention Assessment
Duration - 1 day
Participants complete assessments after finishing the intervention to evaluate outcomes.
1 post-intervention visit approximately 18 weeks after baseline
Follow-up
Duration - 2 months
Participants complete a follow-up assessment two months after the post-intervention visit to monitor ongoing outcomes.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Yeshiva University
The Bronx, New York, United States, 10461
Actively Recruiting
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Research Team
M
Margaret Sala, Ph.D.
H
Hedy Kober, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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