Binge Eating DisorderNCT07212673
Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder
A study testing CBT-based Mindful Courage and Coached Self-Monitoring in people with Binge Eating Disorder, run by Yeshiva University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- CBT-based Mindful Courage and Coached Self-Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yeshiva University
The Bronx, New York, 10461
Margaret Sala, 972-369-4267, margarita.sala@yu.edu
About this study
Official title: Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder: a Feasibility Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Binge Eating Disorder
- Being tested
- CBT-based Mindful Courage, Coached Self-Monitoring
- Keywords
- binge eating, eating disorder, obesity
- Medical subject headings
- Binge-Eating Disorder, Bulimia, Feeding and Eating Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-based Mindful CourageBehavioural
Self-guided online intervention
Coached Self-MonitoringBehavioural
Participants will log meals in recovery record
| Study group | Role | What they receive |
|---|---|---|
| CBT-based Mindful Courage + Coached Self-Monitoring | Experimental | 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. Receives: Behavioral: CBT-based Mindful Courage; Behavioral: Coached Self-Monitoring |
| Coached Self-Monitoring | Active comparator | Participants will be asked to self-monitor their food intake in Recovery Record and will receive phone coaching Receives: Behavioral: Coached Self-Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility / Completion (questionnaire developed by our lab)
Number of participants completing intervention
Measured: 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.
Measured: After completing intervention, an average of 18-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start2 Nov 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeshiva University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Margaret Sala, Yeshiva University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212673
- Sponsor's protocol ID
- 20251574
- Other IDs
- K23AT012126
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sala M, Roos C, Ascarrunz D, Stern CM, Bricker J, Feldman JM, Levinson C, Aslan M, Hay JL, Kober H. Combining Digital Cognitive Behavioral Therapy With Mindfulness Training for Binge Eating Disorder: Protocol for a Feasibility Trial. JMIR Res Protoc. 2026 Apr 17;15:e91761. doi: 10.2196/91761.
PubMed 42061840
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder: a Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07212673
- Acronym / sponsor ID
- 20251574
- Conditions
- Binge Eating Disorder
- Keywords
- binge eating, eating disorder, obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yeshiva UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 2 Nov 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-based Mindful Courage + Coached Self-Monitoring | Experimental | Behavioral: CBT-based Mindful Courage, Behavioral: Coached Self-MonitoringCBT-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. |
| Coached Self-Monitoring | Active comparator | Behavioral: Coached Self-MonitoringParticipants will be asked to self-monitor their food intake in Recovery Record and will receive phone coaching |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-based Mindful CourageSelf-guided online intervention | Behavioural | CBT-based Mindful Courage + Coached Self-Monitoring |
| Coached Self-MonitoringParticipants will log meals in recovery record | Behavioural | CBT-based Mindful Courage + Coached Self-Monitoring, Coached Self-Monitoring |
Primary outcome
Feasibility / Completion (questionnaire developed by our lab)
Time frame: From baseline to 2-month follow-up visit
Number of participants completing intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Derived from this study: PubMed 42061840Sala M, Roos C, Ascarrunz D, Stern CM, Bricker J, Feldman JM, Levinson C, Aslan M, Hay JL, Kober H. Combining Digital Cognitive Behavioral Therapy With Mindfulness Training for Binge Eating Disorder: Protocol for a Feasibility Trial. JMIR Res Protoc. 2026 Apr 17;15:e91761. doi: 10.2196/91761.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-based Mindful Courage and Coached Self-Monitoring in people with Binge Eating Disorder, run by Yeshiva University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret Sala, Ph.D. (19723694267, margarita.sala@yu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility / Completion (questionnaire developed by our lab) (time frame: From baseline to 2-month follow-up visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07212673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.