Trial Outcomes & Findings for App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa (NCT NCT05753410)
NCT ID: NCT05753410
Last Updated: 2026-04-16
Results Overview
Module completion, ranging from 0 to 100%
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
8-week treatment period
Results posted on
2026-04-16
Participant Flow
Participant milestones
| Measure |
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.
Mindful Courage: Self-guided online intervention
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa
Baseline characteristics by cohort
| Measure |
Mindful Courage
n=32 Participants
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.
Mindful Courage: Self-guided online intervention
|
|---|---|
|
Age, Continuous
|
28.8 years
STANDARD_DEVIATION 7.8 • n=193 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
21 Participants
n=193 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
7 Participants
n=193 Participants
|
|
Sex/Gender, Customized
Sex · Non-Binary
|
4 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=193 Participants
|
|
ED Diagnoses
AN-R
|
6 Participants
n=193 Participants
|
|
ED Diagnoses
AN-BP
|
3 Participants
n=193 Participants
|
|
ED Diagnoses
Atypical AN
|
11 Participants
n=193 Participants
|
|
ED Diagnoses
BN
|
7 Participants
n=193 Participants
|
|
ED Diagnoses
Atypical BN
|
5 Participants
n=193 Participants
|
PRIMARY outcome
Timeframe: 8-week treatment periodModule completion, ranging from 0 to 100%
Outcome measures
| Measure |
Mindful Courage
n=32 Participants
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.
Mindful Courage: Self-guided online intervention
|
|---|---|
|
Feasibility of Module Completion
|
87.8 percentage of modules completed
Interval 0.0 to 100.0
|
PRIMARY outcome
Timeframe: 8-week treatment periodSingle-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.
Outcome measures
| Measure |
Mindful Courage
n=30 Participants
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.
Mindful Courage: Self-guided online intervention
|
|---|---|
|
Acceptability Dimensions
|
4.28 units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline through 2-month follow-upEating 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.
Outcome measures
| Measure |
Mindful Courage
n=30 Participants
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.
Mindful Courage: Self-guided online intervention
|
|---|---|
|
Change in Eating Disorder Symptoms
|
-1.42 units on a scale
Standard Error 1.81
|
SECONDARY outcome
Timeframe: Baseline through 2-month follow-upDifficulties 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
Outcome measures
| Measure |
Mindful Courage
n=30 Participants
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.
Mindful Courage: Self-guided online intervention
|
|---|---|
|
Change in Emotion Dysregulation
|
-0.40 units on a scale
Standard Error .99
|
SECONDARY outcome
Timeframe: Baseline through 2-month follow-upBody Shape Questionnaire (BSQ). Total scores are the total across the items, and range from 34 to 204. Higher scores indicate greater body dissatisfaction.
Outcome measures
| Measure |
Mindful Courage
n=30 Participants
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.
Mindful Courage: Self-guided online intervention
|
|---|---|
|
Change in Body Dissatisfaction
|
-26.47 units on a scale
Standard Error 58.44
|
SECONDARY outcome
Timeframe: Baseline through 2-month follow-upSavoring 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.
Outcome measures
| Measure |
Mindful Courage
n=30 Participants
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.
Mindful Courage: Self-guided online intervention
|
|---|---|
|
Savoring Beliefs
|
1.30 units on a scale
Standard Error 1.84
|
SECONDARY outcome
Timeframe: Baseline through 2-month follow-upClinical 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.
Outcome measures
| Measure |
Mindful Courage
n=30 Participants
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.
Mindful Courage: Self-guided online intervention
|
|---|---|
|
Psychosocial Impairment
|
-13.22 units on a scale
Standard Error 16.35
|
SECONDARY outcome
Timeframe: Baseline through 2-month follow-upCognitive and Affective Mindfulness Scale-Revised (CAMS-R). Total scores range from 0 to 40, with higher scores indicating greater mindfulness.
Outcome measures
| Measure |
Mindful Courage
n=30 Participants
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.
Mindful Courage: Self-guided online intervention
|
|---|---|
|
Change in Mindfulness
|
0.33 units on a scale
Standard Error 0.75
|
Adverse Events
Mindful Courage
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place