Back to resultsApp-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa
Primary Purpose
Anorexia Nervosa, Bulimia Nervosa, Anorexia Nervosa, Atypical
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful Courage
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, Bulimia Nervosa, Mindfulness Training, Digital Intervention
Eligibility Criteria
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
Sites / Locations
- Margaret SalaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindful Courage
Arm Description
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.
Outcomes
Primary Outcome Measures
Feasibility
Module completion, ranging from 0 to 100%
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.
Secondary Outcome Measures
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.
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
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.
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.
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.
Change in Mindfulness
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness.
Full Information
NCT ID
NCT05753410
First Posted
February 21, 2023
Last Updated
March 2, 2023
Sponsor
Yeshiva University
Collaborators
Yale University
1. Study Identification
Unique Protocol Identification Number
NCT05753410
Brief Title
App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa
Official Title
Feasibility and Acceptability of an App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeshiva University
Collaborators
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Bulimia Nervosa, Anorexia Nervosa, Atypical, Bulimia; Atypical
Keywords
Anorexia Nervosa, Bulimia Nervosa, Mindfulness Training, Digital Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindful Courage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Courage
Intervention Description
Self-guided online intervention
Primary Outcome Measure Information:
Title
Feasibility
Description
Module completion, ranging from 0 to 100%
Time Frame
8-week treatment period
Title
Acceptability dimensions
Description
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 Outcome Measure Information:
Title
Change in Eating Disorder Symptoms
Description
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.
Time Frame
Baseline to post-treatment (8-weeks) and through 2-month follow-up
Title
Change in Emotion Dysregulation
Description
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
Time Frame
Baseline to post-treatment (8-weeks) and through 2-month follow-up
Title
Change in Body Dissatisfaction
Description
Body Shape Questionnaire (BSQ). Total scores are the total across the items, and range from 34 to 204. Higher scores indicate greater body dissatisfaction.
Time Frame
Baseline to post-treatment (8-weeks) and through 2-month follow-up
Title
Savoring Beliefs
Description
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.
Time Frame
Baseline to post-treatment(8-weeks) and through 2-month follow-up
Title
Psychosocial Impairment
Description
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.
Time Frame
Baseline to post-treatment (8-weeks) and through 2-month follow-up
Title
Change in Mindfulness
Description
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness.
Time Frame
Baseline to post-treatment (8-weeks) and through 2-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Margaret Sala
City
Bronx
State/Province
New York
ZIP/Postal Code
10461-1915
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Sala, PhD
Phone
972-369-4267
Email
margarita.sala@yu.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa
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