Recruiting

Mindfulness-Based CBT vs. Coached Self-Monitoring

Sponsor:

Yeshiva University

Code:

NCT07212673

Conditions

Binge Eating Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

CBT-based Mindful Courage

Coached Self-Monitoring

Study Details

Brief summary:

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.

Conditions

Binge Eating Disorder

Study ID

NCT07212673

Start date

Nov 2, 2025

Status verified date

Nov, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBT-based Mindful Courage + Coached Self-Monitoring

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.

active comparator: Coached Self-Monitoring

Participants will be asked to self-monitor their food intake in Recovery Record and will receive phone coaching

Interventions

CBT-based Mindful Courage

Self-guided online intervention

Coached Self-Monitoring

Participants will log meals in recovery record

Primary outcome measure

  • Feasibility / Completion (questionnaire developed by our lab) [ Time Frame: From baseline to 2-month follow-up visit ]
  • Acceptability [ Time Frame: After completing intervention, an average of 18-weeks ]

Central Contacts and Locations

Central contacts

Margaret Sala, Ph.D.

19723694267margarita.sala@yu.edu

Hedy Kober, Ph.D.

9174708331hedy@berkeley.edu

Locations

Yeshiva University

Recruiting

The Bronx, New York, United States, 10461

Contacts

Margaret Sala

972-369-4267margarita.sala@yu.edu

More Information

Sponsor

Yeshiva University

Last update posted

Nov 4, 2025

Last verified

Nov, 2025

Keywords

  • binge eating
  • eating disorder
  • obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yeshiva University on 2025-11-04.