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

NCT ID: NCT07212673

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-02

Study Completion Date

2027-10-01

Brief Summary

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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

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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

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Binge Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

CBT-based Mindful Courage

Intervention Type BEHAVIORAL

Self-guided online intervention

Coached Self-Monitoring

Intervention Type BEHAVIORAL

Participants will log meals in recovery record

Coached Self-Monitoring

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

Group Type ACTIVE_COMPARATOR

Coached Self-Monitoring

Intervention Type BEHAVIORAL

Participants will log meals in recovery record

Interventions

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CBT-based Mindful Courage

Self-guided online intervention

Intervention Type BEHAVIORAL

Coached Self-Monitoring

Participants will log meals in recovery record

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Yeshiva University

OTHER

Sponsor Role lead

Responsible Party

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Margaret Sala

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yeshiva University

The Bronx, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Margaret Sala, Ph.D.

Role: CONTACT

19723694267

Hedy Kober, Ph.D.

Role: CONTACT

9174708331

Facility Contacts

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Margaret Sala

Role: primary

972-369-4267

Other Identifiers

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K23AT012126

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20251574

Identifier Type: -

Identifier Source: org_study_id

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