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NCT Number: NCT07212673

Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeshiva University

The Bronx, New York, 10461, United States

Location status: Recruiting

Location contact

Margaret Sala

CONTACT

[email protected]

972-369-4267

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT-based Mindful Courage

Behavioral

Self-guided online intervention

Coached Self-Monitoring

Behavioral

Participants will log meals in recovery record

Primary outcomes

  1. Feasibility / Completion (questionnaire developed by our lab)

    Time frame: From baseline to 2-month follow-up visit

    Number of participants completing intervention

  2. Acceptability

    Time frame: After completing intervention, an average of 18-weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hedy Kober, Ph.D.

CONTACT

[email protected]

9174708331

Margaret Sala, Ph.D.

CONTACT

[email protected]

19723694267

Sponsors and collaborators

Lead sponsor

Yeshiva University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder: a Feasibility Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 8, 2025
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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