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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 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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital CBT-MM | Experimental | Digital CBT-MM is a digital intervention including mindfulness and cognitive behavioral elements for individuals with binge eating disorder. Mindful Courage will consist of 18-weeks of 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 (including foods that patients may fear), 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation-enhanced Cognitive Behavioral Therapy | Behavioral | Self-guided online intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | 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. | 18-week treatment period |
| Feasibility/Completion | Module completion, ranging from 0 to 100% | 18-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Emotion Dysregulation | 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 | Baseline to post-treatment (18-weeks) |
| Changes in Mindfulness |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeshiva University | The Bronx | New York | 10461 | United States |
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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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Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness. |
| Baseline to post-treatment (18-weeks) |
| Changes in Objective Binge Eating Episodes | 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. | Baseline to post-treatment (18-weeks) |
| Change in Body Mass Index (BMI) | Computed using self-reported height and body weight | Baseline to post-treatment (18-weeks) |
| Changes in Dietary Restraint | Dietary restraint subscale of the EDE-Q (EDE-Q; Fairburn & Beglin, 1994). Scores range from 0 to 6, and higher scores indicate higher restraint. | Baseline to post-treatment (18-weeks) |
| Changes in Quality of Life | 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. | Baseline to post-treatment (18-weeks) |
| Changes in Depression Symptoms | Beck Depression Inventory-II (BDI-II; Beck et al., 1996). Scores range from 0 to 63, with higher scores indicating higher depression symptoms. | Baseline to post-treatment (18-weeks) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |