An interventional study of CBT-based Mindful Courage and Coached Self-Monitoring in Binge Eating Disorder, sponsored by Yeshiva University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-04.
Sponsored by Yeshiva University · Not applicable, Interventional, and Treatment
The investigators will evaluate the acceptability and feasibility of a 16-session digital mindfulness-based and cognitive behavioral therapy (CBT) intervention for binge eating disorder (BED) + coached self-monitoring vs. a coached self-monitoring intervention. This study is a pilot randomized controlled trial.
Procedures include completing: (1) pre-intervention screening assessment; (2) an initial baseline visit; (3) the assigned intervention; (4) a mid-study visit; (5) a post-intervention assessment (\~18-weeks after baseline); and (6) a 2-month follow-up assessment.
233 studies on the registry are indexed under Binge-Eating Disorder; 53 are open to participants now.
This study's planned enrollment of 40 is below the median of 77 across 190 interventional studies indexed under Binge-Eating Disorder.
Browse Binge-Eating Disorder studies →Yeshiva University is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CBT-based Mindful Courage is a digital intervention including mindfulness and CBT elements for individuals with binge eating disorder. It will consist of 16 self-guided modules. Elements included in the intervention include psychoeducation, self-monitoring, regular eating, goal-setting, weekly weighing, eating a sufficient amount of food at each meal, eating a range of foods reduction of overvaluation of weight and shape, addressing shape/body checking or avoidance, behavior chain analysis, problem solving, awareness and acceptance of binge eating urges, thoughts and emotions, values awareness, values clarification, values-based decision making, self-compassion, exploring needs underlying binge eating urges, mindful eating, hunger and fullness awareness, self-compassion, and self-care. Weekly mindfulness practice (at least 3x per week) is heavily emphasized. Participants will also be asked to self-monitor their food intake in Recovery Record and will receive phone coaching.
Behavioral: CBT-based Mindful Courage · Behavioral: Coached Self-Monitoring
Participants will be asked to self-monitor their food intake in Recovery Record and will receive phone coaching
Behavioral: Coached Self-Monitoring
Self-guided online intervention
Participants will log meals in recovery record
Feasibility / Completion (questionnaire developed by our lab)
Number of participants completing intervention
Time frame: From baseline to 2-month follow-up visit
Acceptability
Dimensions of usability from the System Usability Scale; single-items measuring dimensions of acceptability, including 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. Scores for each item range from 1 to 5, with higher scores indicating better acceptability. Scores will be averaged to obtain acceptability ratings.
Time frame: After completing intervention, an average of 18-weeks
Plan to share: No
Started Nov 2025 (actual). Primary completion is estimated for Oct 2027, 22 months after the start.
Of 84 non-industry interventional studies with no phase under Binge-Eating Disorder, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's planned 22 months is below that.
Counting every sponsor, half of 89 studies reached it within 25 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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