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

Yeshiva University

Status: Enrolling

Conditions: Binge Eating Disorder

Treatments: Behavioral: CBT-based Mindful Courage; Behavioral: Coached Self-Monitoring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07212673

K23AT012126 (U.S. NIH Grant/Contract)

20251574

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

CBT-based Mindful Courage + Coached Self-Monitoring

Experimental group

Description:

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.

Treatment:

Behavioral: Coached Self-Monitoring

Behavioral: CBT-based Mindful Courage

Coached Self-Monitoring

Active Comparator group

Description:

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

Treatment:

Behavioral: Coached Self-Monitoring