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

NCT05753410 | Completed Results

• 1 other identifier: 20204635
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Anorexia Nervosa; Bulimia Nervosa; Mindfulness Training; Digital Intervention

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Change in Eating Disorder Symptoms

  Baseline through 2-month follow-up

• Change in Emotion Dysregulation

  Baseline through 2-month follow-up

• Change in Body Dissatisfaction

  Baseline through 2-month follow-up

• Savoring Beliefs

  Baseline through 2-month follow-up

• Psychosocial Impairment

  Baseline through 2-month follow-up

Study Arms (1)

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.

Behavioral: Mindful Courage

Interventions

Mindful Courage BEHAVIORAL

Self-guided online intervention

Mindful Courage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeshiva University: lead
• Yale University: collaborator

Study Sites (1)

Margaret Sala

The Bronx, New York, 10461-1915, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Bulimia Nervosa; Bulimia

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Margaret Sala
• Organization: Yeshiva Univeristy

margarita.sala@yu.edu

972-369-4267

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: March 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 16, 2026
• Results First Posted: April 16, 2026

Record last verified: 2026-03

Locations

US (1)