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

Not Applicable

Completed

• Conditions: Bulimia Nervosa; Anorexia Nervosa, Atypical; Anorexia Nervosa; Bulimia; Atypical
• Interventions: Behavioral: Mindful Courage

• Registration Number: NCT05753410
• Lead Sponsor: Yeshiva University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-02-21
• Study Start: 2023-03-01
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-03
• Status Verified: 2025-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindful Courage	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.

Primary Outcome Measures

Name	Time	Method
Acceptability dimensions	8-week treatment period	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.
Feasibility	8-week treatment period	Module completion, ranging from 0 to 100%

Secondary Outcome Measures

Name	Time	Method
Savoring Beliefs	Baseline to post-treatment(8-weeks) and through 2-month follow-up	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.
Change in Mindfulness	Baseline to post-treatment (8-weeks) and through 2-month follow-up	Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness.
Change in Eating Disorder Symptoms	Baseline to post-treatment (8-weeks) and through 2-month follow-up	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.
Psychosocial Impairment	Baseline to post-treatment (8-weeks) and through 2-month follow-up	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.
Change in Emotion Dysregulation	Baseline to post-treatment (8-weeks) and through 2-month follow-up	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
Change in Body Dissatisfaction	Baseline to post-treatment (8-weeks) and through 2-month follow-up	Body Shape Questionnaire (BSQ). Total scores are the total across the items, and range from 34 to 204. Higher scores indicate greater body dissatisfaction.

Trial Locations

Locations (1)

Margaret Sala; 🇺🇸 Bronx, New York, United States