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

Sponsor

Yeshiva University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05753410

Collaborator

Yale University (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa Bulimia Nervosa Anorexia Nervosa, Atypical Bulimia; Atypical	Behavioral: Mindful Courage	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Mindful Courage Self-guided online intervention

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Mindful Courage

Self-guided online intervention

Outcome Measures

Primary Outcome Measures

Feasibility [8-week treatment period]
Module completion, ranging from 0 to 100%
Acceptability dimensions [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, , with higher scores indicating better acceptability.

Secondary Outcome Measures

Change in Eating Disorder Symptoms [Baseline to post-treatment (8-weeks) and 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.
Change in Emotion Dysregulation [Baseline to post-treatment (8-weeks) and 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
Change in Body Dissatisfaction [Baseline to post-treatment (8-weeks) and 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.
Savoring Beliefs [Baseline to post-treatment(8-weeks) and 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.
Psychosocial Impairment [Baseline to post-treatment (8-weeks) and 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.
Change in Mindfulness [Baseline to post-treatment (8-weeks) and 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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