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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07212673
Enrollment
40
Registered
2025-10-08
Start date
2025-11-02
Completion date
2027-10-01
Last updated
2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating Disorder

Keywords

binge eating, eating disorder, obesity

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.

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.

Interventions

BEHAVIORALCBT-based Mindful Courage

Self-guided online intervention

BEHAVIORALCoached Self-Monitoring

Participants will log meals in recovery record

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Yeshiva University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility / Completion (questionnaire developed by our lab)From baseline to 2-month follow-up visitNumber of participants completing intervention
AcceptabilityAfter completing intervention, an average of 18-weeksDimensions 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.

Countries

United States

Contacts

Primary ContactMargaret Sala, Ph.D.
margarita.sala@yu.edu19723694267
Backup ContactHedy Kober, Ph.D.
hedy@berkeley.edu9174708331

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026