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| Name | Class |
|---|---|
| Yale University | OTHER |
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We will evaluate the acceptability and feasibility of a 8-week long digital mindfulness-based intervention for anorexia nervosa and bulimia nervosa.
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) brief daily assessments for the first and last weeks of the study (4 times per day); (3) an initial baseline visit; (4) 8-week web-based intervention (3) a post-intervention assessment (8-weeks after baseline); and (4) a brief 8-week follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindful Courage | Experimental | Mindful Courage is a digital intervention including mindfulness and cognitive behavioral elements for individuals with anorexia nervosa or bulimia nervosa. Mindful Courage will consist of 8-weeks of self-guided modules which will be completed over the course of 8 weeks. Elements included in the intervention include psychoeducation, self-monitoring, regular eating, body image, values clarification, and mindful awareness and acceptance. Participants learn a range mindfulness skills and practice a range of mindfulness meditations. Participants will also receive phone coaching. Homework consists of meditation practices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful Courage | Behavioral | Self-guided online intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Module Completion | Module completion, ranging from 0 to 100% | 8-week treatment period |
| Acceptability Dimensions | Single-items measuring ratings of acceptability dimensions, including usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills ratings. Scores for each item range from 1 to 5 and are averaged, with higher scores indicating better acceptability. | 8-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Eating Disorder Symptoms | Eating Disorder Examination-Questionnaire (EDE-Q). Total scores are the average of each of the subscales, and range from 0 to 6. Higher scores indicate higher eating disorder symptoms. | Baseline through 2-month follow-up |
| Change in Emotion Dysregulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Margaret Sala | The Bronx | New York | 10461-1915 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindful Courage | Mindful Courage is a digital intervention including mindfulness and cognitive behavioral elements for individuals with anorexia nervosa or bulimia nervosa. Mindful Courage will consist of 8-weeks of self-guided modules which will be completed over the course of 8 weeks. Elements included in the intervention include psychoeducation, self-monitoring, regular eating, body image, values clarification, and mindful awareness and acceptance. Participants learn a range mindfulness skills and practice a range of mindfulness meditations. Participants will also receive phone coaching. Homework consists of meditation practices. Mindful Courage: Self-guided online intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindful Courage | Mindful Courage is a digital intervention including mindfulness and cognitive behavioral elements for individuals with anorexia nervosa or bulimia nervosa. Mindful Courage will consist of 8-weeks of self-guided modules which will be completed over the course of 8 weeks. Elements included in the intervention include psychoeducation, self-monitoring, regular eating, body image, values clarification, and mindful awareness and acceptance. Participants learn a range mindfulness skills and practice a range of mindfulness meditations. Participants will also receive phone coaching. Homework consists of meditation practices. Mindful Courage: Self-guided online intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Module Completion | Module completion, ranging from 0 to 100% | Posted | Mean | Full Range | percentage of modules completed | 8-week treatment period |
|
Each participant was followed for 2 months after intervention completion.
No serious or all-cause mortality adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindful Courage | Mindful Courage is a digital intervention including mindfulness and cognitive behavioral elements for individuals with anorexia nervosa or bulimia nervosa. Mindful Courage will consist of 8-weeks of self-guided modules which will be completed over the course of 8 weeks. Elements included in the intervention include psychoeducation, self-monitoring, regular eating, body image, values clarification, and mindful awareness and acceptance. Participants learn a range mindfulness skills and practice a range of mindfulness meditations. Participants will also receive phone coaching. Homework consists of meditation practices. Mindful Courage: Self-guided online intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Sala | Yeshiva Univeristy | 972-369-4267 | margarita.sala@yu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2023 | Jan 13, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D052018 | Bulimia Nervosa |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
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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 through 2-month follow-up |
| Change in Body Dissatisfaction | Body Shape Questionnaire (BSQ). Total scores are the total across the items, and range from 34 to 204. Higher scores indicate greater body dissatisfaction. | Baseline through 2-month follow-up |
| Savoring Beliefs | Savoring Beliefs Inventory (SBI). Total scores are the total across the positively-anchored and negatively-anchored items, and could range from -72 to 72. Higher scores reflect stronger endorsement of savoring beliefs. | Baseline through 2-month follow-up |
| Psychosocial Impairment | Clinical Impairment Assessment Questionnaire (CIA). Total scores are the total of the items, and range from 0 to 48. Higher scores indicate greater psychosocial impairment associated with an eating disorder. | Baseline through 2-month follow-up |
| Change in Mindfulness | Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness. | Baseline through 2-month follow-up |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| ED Diagnoses | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Acceptability Dimensions | Single-items measuring ratings of acceptability dimensions, including usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills ratings. Scores for each item range from 1 to 5 and are averaged, with higher scores indicating better acceptability. | Posted | Mean | Standard Deviation | units on a scale | 8-week treatment period |
|
|
|
| Secondary | Change in Eating Disorder Symptoms | Eating Disorder Examination-Questionnaire (EDE-Q). Total scores are the average of each of the subscales, and range from 0 to 6. Higher scores indicate higher eating disorder symptoms. | Posted | Mean | Standard Error | units on a scale | Baseline through 2-month follow-up |
|
|
|
| Secondary | Change 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 | Posted | Mean | Standard Error | units on a scale | Baseline through 2-month follow-up |
|
|
|
| Secondary | Change in Body Dissatisfaction | Body Shape Questionnaire (BSQ). Total scores are the total across the items, and range from 34 to 204. Higher scores indicate greater body dissatisfaction. | Posted | Mean | Standard Error | units on a scale | Baseline through 2-month follow-up |
|
|
|
| Secondary | Savoring Beliefs | Savoring Beliefs Inventory (SBI). Total scores are the total across the positively-anchored and negatively-anchored items, and could range from -72 to 72. Higher scores reflect stronger endorsement of savoring beliefs. | Posted | Mean | Standard Error | units on a scale | Baseline through 2-month follow-up |
|
|
|
| Secondary | Psychosocial Impairment | Clinical Impairment Assessment Questionnaire (CIA). Total scores are the total of the items, and range from 0 to 48. Higher scores indicate greater psychosocial impairment associated with an eating disorder. | Posted | Mean | Standard Error | units on a scale | Baseline through 2-month follow-up |
|
|
|
| Secondary | Change in Mindfulness | Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness. | Posted | Mean | Standard Error | units on a scale | Baseline through 2-month follow-up |
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| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |