Trial Outcomes & Findings for FlexED: A Digital, Gamified Early Intervention for Eating Disorders (NCT NCT05609409)
NCT ID: NCT05609409
Last Updated: 2026-07-06
Results Overview
5-item measure assessing the ability to behave flexibly in the presence of negative thoughts and feelings about the body. Scores range from 5 to 35 with higher scores indicating greater flexibility.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Baseline, 6-8 weeks and 12 weeks
Results posted on
2026-07-06
Participant Flow
Participants were recruited using electronic health record messaging. Messages were sent to females between the ages of 15-25 years old in the Duke Health System. The study was also posted online, including to a Duke student list.
Aim 1 Parts 1-3 participants were not considered enrolled in this clinical trial. Ten participants were enrolled in the study, then did not pass the second stage of screening (leaving N=24 assigned to treatment). The last four participants assigned to treatment were assigned to the condensed schedule, rather than randomized to one of the three trial arms/baseline durations.
Participant milestones
| Measure |
2 Weeks No Intervention, Then 8 Weeks Intervention
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.
|
4 Weeks No Intervention, Then 8 Weeks Intervention
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.
|
6 Weeks No Intervention, Then 8 Weeks Intervention
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.
|
2 Weeks No Intervention, Then 4 Weeks Intervention (Non-randomized Condensed Schedule)
Two sessions per week
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.
|
|---|---|---|---|---|
|
6-8 Weeks (End-of-Treatment)
STARTED
|
6
|
7
|
7
|
4
|
|
6-8 Weeks (End-of-Treatment)
COMPLETED
|
5
|
7
|
5
|
3
|
|
6-8 Weeks (End-of-Treatment)
NOT COMPLETED
|
1
|
0
|
2
|
1
|
|
12 Weeks (~1 Month Post)
STARTED
|
5
|
7
|
5
|
3
|
|
12 Weeks (~1 Month Post)
COMPLETED
|
4
|
5
|
3
|
3
|
|
12 Weeks (~1 Month Post)
NOT COMPLETED
|
1
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
2 Weeks No Intervention, Then 8 Weeks Intervention
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.
|
4 Weeks No Intervention, Then 8 Weeks Intervention
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.
|
6 Weeks No Intervention, Then 8 Weeks Intervention
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.
|
2 Weeks No Intervention, Then 4 Weeks Intervention (Non-randomized Condensed Schedule)
Two sessions per week
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.
|
|---|---|---|---|---|
|
6-8 Weeks (End-of-Treatment)
Lost to Follow-up
|
1
|
0
|
2
|
1
|
|
12 Weeks (~1 Month Post)
Lost to Follow-up
|
1
|
2
|
2
|
0
|
Baseline Characteristics
FlexED: A Digital, Gamified Early Intervention for Eating Disorders
Baseline characteristics by cohort
| Measure |
2 Weeks No Intervention, Then 8 Weeks Intervention
n=6 Participants
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.
|
4 Weeks No Intervention, Then 8 Weeks Intervention
n=7 Participants
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.
|
6 Weeks No Intervention, Then 8 Weeks Intervention
n=7 Participants
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.
|
2 Weeks No Intervention, Then 4 Weeks Intervention (Condensed Schedule)
n=4 Participants
Two sessions per week
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
17.8 years
STANDARD_DEVIATION 1.9 • n=9 Participants
|
20.3 years
STANDARD_DEVIATION 4.1 • n=27 Participants
|
19.7 years
STANDARD_DEVIATION 3.2 • n=267 Participants
|
23.0 years
STANDARD_DEVIATION 1.4 • n=265 Participants
|
20.0 years
STANDARD_DEVIATION 3.3 • n=568 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
24 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
14 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
21 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
24 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6-8 weeks and 12 weeksPopulation: N=20 participants were randomized to a baseline duration of 2, 4 or 6 weeks. N=2 participants randomized to a baseline duration were lost prior to starting treatment, leaving N=18 for analysis. Participants assigned to the condensed schedule were not included in primary analyses.
5-item measure assessing the ability to behave flexibly in the presence of negative thoughts and feelings about the body. Scores range from 5 to 35 with higher scores indicating greater flexibility.
Outcome measures
| Measure |
FlexED Digital Intervention
n=18 Participants
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of up to eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following a character through a story line and completing interactive exercises and games. The first 6 sessions are core. The remaining 2 sessions are additional practice.
|
|---|---|
|
Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
Baseline
|
17.4 Scale Score
Standard Deviation 6.8
|
|
Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
End-of-Treatment (Weeks 6-8)
|
20.5 Scale Score
Standard Deviation 4.4
|
|
Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
Week 12 (~1 Month Post)
|
22.9 Scale Score
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: Baseline, 6-8 weeks, and 12 weeksPopulation: N=20 participants were randomized to a baseline duration of 2, 4 or 6 weeks. N=2 participants randomized to a baseline duration were lost prior to starting treatment, leaving N=18 for analysis. Participants assigned to the condensed schedule were not included in primary analyses.
Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress. Indexed by HF Power ms\^2 (Induction-Rest).
Outcome measures
| Measure |
FlexED Digital Intervention
n=18 Participants
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of up to eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following a character through a story line and completing interactive exercises and games. The first 6 sessions are core. The remaining 2 sessions are additional practice.
|
|---|---|
|
High Frequency Heart Rate Variability (HF-HRV)
Baseline
|
-10.1 ms^2
Standard Deviation 689.3
|
|
High Frequency Heart Rate Variability (HF-HRV)
Weeks 6-8 (End-of-Treatment)
|
29.4 ms^2
Standard Deviation 552.4
|
|
High Frequency Heart Rate Variability (HF-HRV)
Week 12 (~1 Month post)
|
-351.0 ms^2
Standard Deviation 604.3
|
PRIMARY outcome
Timeframe: Baseline, 6-8 weeks, and 12 weeksPopulation: N=20 participants were randomized to a baseline duration of 2, 4 or 6 weeks. N=2 participants randomized to a baseline duration were lost prior to starting treatment, leaving N=18 for analysis. Participants assigned to the condensed schedule were not included in primary analyses.
Biased processing of stimuli is assessed using an emotional Stroop task with body image and neutral stimuli. Improvements are indicated by decreases in bias score (decreases in difference in reaction time between evocative and neutral stimuli).
Outcome measures
| Measure |
FlexED Digital Intervention
n=18 Participants
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of up to eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following a character through a story line and completing interactive exercises and games. The first 6 sessions are core. The remaining 2 sessions are additional practice.
|
|---|---|
|
Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli
Baseline
|
65.1 milliseconds
Standard Deviation 91.8
|
|
Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli
Weeks 6-8 (End-of-Treatment)
|
2.1 milliseconds
Standard Deviation 61.0
|
|
Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli
Week 12 (~1-Month Post)
|
31.2 milliseconds
Standard Deviation 62.1
|
PRIMARY outcome
Timeframe: Baseline, 6-8 weeks, 12 weeksPopulation: N=20 participants were randomized to a baseline duration of 2, 4 or 6 weeks. N=2 participants randomized to a baseline duration were lost prior to starting treatment, leaving N=18 for analysis. Participants assigned to the condensed schedule were not included in primary analyses.
10-item measure assessing psychological flexibility. Total scores range from 10 to 70 with higher scores indicating greater flexibility.
Outcome measures
| Measure |
FlexED Digital Intervention
n=18 Participants
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of up to eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following a character through a story line and completing interactive exercises and games. The first 6 sessions are core. The remaining 2 sessions are additional practice.
|
|---|---|
|
CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)
Week 12 (~1 Month post)
|
38.2 Scale Score
Standard Deviation 8.05
|
|
CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)
Baseline
|
32.4 Scale Score
Standard Deviation 6.21
|
|
CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)
Weeks 6-8 (End-of-Treatment)
|
36.3 Scale Score
Standard Deviation 8.09
|
PRIMARY outcome
Timeframe: Baseline, 6-8 weeks, 12 weeksPopulation: N=20 participants were randomized to a baseline duration of 2, 4 or 6 weeks. N=2 participants randomized to a baseline duration were lost prior to starting treatment, leaving N=18 for analysis. Participants assigned to the condensed schedule were not included in primary analyses.
Number of fixations on body and food related images presented during HF-HRV task.
Outcome measures
| Measure |
FlexED Digital Intervention
n=18 Participants
Eight 20-30 minute sessions of an online, multimedia application
FlexED: Intervention consists of up to eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following a character through a story line and completing interactive exercises and games. The first 6 sessions are core. The remaining 2 sessions are additional practice.
|
|---|---|
|
Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli
Baseline
|
417.9 number of fixations
Standard Deviation 84.9
|
|
Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli
6-8 weeks (End-of-Treatment)
|
385.1 number of fixations
Standard Deviation 97.7
|
|
Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli
12 weeks (~1 Month post)
|
394.8 number of fixations
Standard Deviation 81.0
|
Adverse Events
2 Weeks No Intervention, Then 8 Weeks Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4 Weeks No Intervention, Then 8 Weeks Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6 Weeks No Intervention, Then 8 Weeks Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Weeks No Intervention, Then 4 Weeks Intervention
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