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

Yeshiva University

Status: Completed

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

Treatments: Behavioral: Mindful Courage

Study type: Interventional

Funder types: Other

Identifiers

NCT05753410

20204635

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Mindful Courage

Experimental group

Description:

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.

Treatment:

Behavioral: Mindful Courage