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

Yeshiva University32 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anorexia Nervosa Bulimia Nervosa Anorexia Nervosa, Atypical Bulimia; Atypical

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Feasibility

Module completion, ranging from 0 to 100%

Time frame: 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.

Time frame: 8-week treatment period

Secondary Outcomes

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.