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Completed

NCT Number: NCT06604299

Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy (CBT-MM) for Binge Eating Disorder

The investigators will evaluate the acceptability and feasibility of a 18-week long digital mindfulness-based and cognitive behavioral therapy intervention for binge eating disorder.

This study is a prospective single-arm trial during the intervention development phase. Following this phase, after the intervention has been further developed, a subsequent study (with a different clinicaltrials.gov identification #) will utilize a randomized control trial design.

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Key information

Conditions

Binge Eating Disorder Binge-Eating Disorder Body Weight Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeshiva University

The Bronx, New York, 10461, United States

About this study

Procedures include completing: (1) pre-intervention screening assessment; (2) an initial baseline visit; (3) 18-week web-based intervention; and (4) a post-intervention assessment (18-weeks after baseline).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 or older
  • Meeting DSM-5 criteria for Binge Eating Disorder (BED)
  • English-speaking

Exclusion criteria

  • BMI < 18.5
  • Requiring immediate treatment for medical complications
  • Current anorexia or bulimia nervosa or purging behaviors within the past year
  • Already receiving treatment for an ED or participating in a weight loss program or psychotherapy focused on weight (psychotherapy for other conditions was allowed)
  • Currently 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 psychotic disorder, cancer)

Treatment and study plan

Meditation-enhanced Cognitive Behavioral Therapy

Behavioral

Self-guided online intervention

Primary outcomes

  1. Acceptability

    Time frame: 18-week treatment period

    Single-items measuring dimensions of acceptability, including overall satisfaction, engagement, visual appeal of content, understandability of program material, desire to continue the program, and overall helpfulness. Scores for each item range from 1 to 5, , with higher scores indicating better acceptability.

  2. Feasibility/Completion

    Time frame: 18-week treatment period

    Module completion, ranging from 0 to 100%

Secondary outcomes

  1. Changes in Emotion Dysregulation

    Time frame: Baseline to post-treatment (18-weeks)

    Difficulties in Emotion Regulation Short Form (DERS-SF). Total scores are the average of each of the subscales, and range from 1 to 5. Higher scores indicate more emotion dysregulation

  2. Changes in Mindfulness

    Time frame: Baseline to post-treatment (18-weeks)

    Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness.

  3. Changes in Objective Binge Eating Episodes

    Time frame: Baseline to post-treatment (18-weeks)

    Eating Disorder Examination-Questionnaire (EDE-Q). The EDE-Q asks participants to report on the number of episodes in the last 28 days in which they ate a large amount of food with a sense of loss of control.

  4. Change in Body Mass Index (BMI)

    Time frame: Baseline to post-treatment (18-weeks)

    Computed using self-reported height and body weight

  5. Changes in Dietary Restraint

    Time frame: Baseline to post-treatment (18-weeks)

    Dietary restraint subscale of the EDE-Q (EDE-Q; Fairburn & Beglin, 1994). Scores range from 0 to 6, and higher scores indicate higher restraint.

  6. Changes in Quality of Life

    Time frame: Baseline to post-treatment (18-weeks)

    Eating Disorder Quality of Life scale (EDQOL; Engel et al., 1996). Scores on each item range from 1 to 4, with higher scores indicating better quality of life.

  7. Changes in Depression Symptoms

    Time frame: Baseline to post-treatment (18-weeks)

    Beck Depression Inventory-II (BDI-II; Beck et al., 1996). Scores range from 0 to 63, with higher scores indicating higher depression symptoms.

Sponsors and collaborators

Lead sponsor

Yeshiva University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy (CBT-MM) for Binge Eating Disorder User-Testing

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Feb 12, 2026

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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