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

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753410
• Other study ID #: 20204635
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2023
• Source: Yeshiva University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Mindful Courage
Self-guided online intervention

Locations

Country	Name	City	State
United States	Margaret Sala	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Yeshiva University	Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Module completion, ranging from 0 to 100%	8-week treatment period
Primary	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.	8-week treatment period
Secondary	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.	Baseline to post-treatment (8-weeks) and through 2-month follow-up
Secondary	Change in Emotion Dysregulation	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	Baseline to post-treatment (8-weeks) and through 2-month follow-up
Secondary	Change in Body Dissatisfaction	Body Shape Questionnaire (BSQ). Total scores are the total across the items, and range from 34 to 204. Higher scores indicate greater body dissatisfaction.	Baseline to post-treatment (8-weeks) and through 2-month follow-up
Secondary	Savoring Beliefs	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.	Baseline to post-treatment(8-weeks) and through 2-month follow-up
Secondary	Psychosocial Impairment	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.	Baseline to post-treatment (8-weeks) and through 2-month follow-up
Secondary	Change in Mindfulness	Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness.	Baseline to post-treatment (8-weeks) and through 2-month follow-up