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Completed

NCT Number: NCT05753410

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

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.

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Key information

Conditions

Anorexia Nervosa Anorexia Nervosa, Atypical Bulimia Bulimia Nervosa Bulimia; Atypical Feeding and Eating Disorders Hyperphagia Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Margaret Sala

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindful Courage

Behavioral

Self-guided online intervention

Primary outcomes

  1. Feasibility of Module Completion

    Time frame: 8-week treatment period

    Module completion, ranging from 0 to 100%

  2. Acceptability Dimensions

    Time frame: 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 and are averaged, with higher scores indicating better acceptability.

Secondary outcomes

  1. Change in Eating Disorder Symptoms

    Time frame: Baseline 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.

  2. Change in Emotion Dysregulation

    Time frame: Baseline 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

  3. Change in Body Dissatisfaction

    Time frame: Baseline 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.

  4. Savoring Beliefs

    Time frame: Baseline 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.

  5. Psychosocial Impairment

    Time frame: Baseline 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.

  6. Change in Mindfulness

    Time frame: Baseline 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.

Sponsors and collaborators

Lead sponsor

Yeshiva University

Other

Collaborators

  • Yale University

Registry information

Official study title

Feasibility and Acceptability of an App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2023
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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