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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT012126 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Coached Self-Monitoring | Active Comparator | Participants will be asked to self-monitor their food intake in Recovery Record and will receive phone coaching |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-based Mindful Courage | Behavioral | Self-guided online intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility / Completion (questionnaire developed by our lab) | Number of participants completing intervention | 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. | After completing intervention, an average of 18-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margaret Sala, Ph.D. | Contact | 19723694267 | margarita.sala@yu.edu | |
| Hedy Kober, Ph.D. | Contact | 9174708331 | hedy@berkeley.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeshiva University | Recruiting | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42061840 | Derived | 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. |
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| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| D002032 | Bulimia |
| D001068 | Feeding and Eating Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| Coached Self-Monitoring | Behavioral | Participants will log meals in recovery record |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |