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

NCT ID: NCT05753410

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-01-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindful Courage

Intervention Type: BEHAVIORAL

Self-guided online intervention

Interventions

Mindful Courage

Self-guided online intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

Yeshiva University

OTHER

Sponsor Role: lead

Responsible Party

Margaret Sala

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Margaret Sala

The Bronx, New York, United States

Countries

United States

Other Identifiers

20204635

Identifier Type: -

Identifier Source: org_study_id