App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility and Acceptability of an App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa

Conditions
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Anorexia Nervosa, Bulimia Nervosa, Anorexia Nervosa, Atypical, Bulimia; Atypical

Intervention / Treatment
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* Behavioral: Mindful Courage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Can read and write in English Meet diagnostic DSM 5 diagnostic criteria for anorexia nervosa, bulimia nervosa, or atypical anorexia nervosa/bulimia nervosa Owns a smartphone Willing and able to participate in an eight-week long research study Have a private quiet space at home or headphones to complete modules Completed one month or more of eating disorder treatment Currently enrolled in eating disorder treatment Exclusion Criteria: Fail to meet above-listed inclusion criteria Current alcohol or drug dependence Current untreated psychotic or bipolar disorder Current suicidal intent Significant cognitive impairment that would impair the ability to use Mindful Courage effectively BMI <15 or medically unstable Currently receiving residential/inpatient treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Courage<br>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. | Behavioral: Mindful Courage<br>* Self-guided online intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | 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, , with higher scores indicating better acceptability. | 8-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | 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 to post-treatment (8-weeks) and through 2-month follow-up | 
| 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 | Baseline to post-treatment (8-weeks) and 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 to post-treatment (8-weeks) and 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 to post-treatment(8-weeks) and 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 to post-treatment (8-weeks) and 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 to post-treatment (8-weeks) and through 2-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia Nervosa, Bulimia Nervosa, Mindfulness Training, Digital Intervention