FlexED: A Digital, Gamified Early Intervention for Eating Disorders
June 9, 2026 updated by: Duke University
The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old.
Participants complete up to 8 digital sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Everyone in the study completes the intervention after different periods of time (2, 4 or 6 weeks) of completing assessments.
Researchers will examine the impact of the intervention on participants ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye gaze, and reaction time to body-image related words and images, and test how long it takes to see change.
Study Overview
Detailed Description
This multiple baseline experiment tests the impact of a digital, gamified early intervention for eating disorders on body-image psychological flexibility and assesses treatment dose.
Twenty-four young women and girls with eating disorder (ED) symptoms are randomized to baseline duration between 2-6 weeks.
Participants complete up to eight 20-30 minute sessions of a multimedia application using their mobile phone.
Psychological flexibility is measured repeatedly using a multi-level, multi-dimensional assessment strategy of self-report and lab-based tasks assessing flexibility in cognition, affect and attention with body-image related stimuli during the baseline and treatment phases to estimate treatment effects.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Female identified 15-25 years old
- Weight Concerns Scale score of >47
- Eating disorder behaviors with onset at current level <3 years
Exclusion Criteria:
- Currently meet diagnostic criteria for anorexia or bulimia nervosa
- Psychosis, substance use disorder or current suicidal ideation or self-harm.
- Start or change in psychiatric medications within the past month.
- NonEnglish Speaking.
- Presents with other specified feeding or eating disorder (OSFED) that does not includes weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 2-Week Baseline Duration
2 weeks of assessment, then 8 weeks of intervention
|
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.
|
|
Experimental: 4-Week Baseline Duration
4 weeks of assessment, then 8 weeks of intervention
|
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.
|
|
Experimental: 6-Week Baseline Duration
6 weeks of assessment, then 8 weeks of intervention
|
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.
|
|
Experimental: Condensed schedule
2 weeks of assessment, then 4 weeks of intervention (sessions twice a week)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
Time Frame: Baseline, 6-8 weeks and 12 weeks
|
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.
|
Baseline, 6-8 weeks and 12 weeks
|
|
High Frequency Heart Rate Variability (HF-HRV)
Time Frame: Baseline, 6-8 weeks, and 12 weeks
|
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).
|
Baseline, 6-8 weeks, and 12 weeks
|
|
Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli
Time Frame: Baseline, 6-8 weeks, and 12 weeks
|
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).
|
Baseline, 6-8 weeks, and 12 weeks
|
|
CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)
Time Frame: Baseline, 6-8 weeks, 12 weeks
|
10-item measure assessing psychological flexibility.
Total scores range from 10 to 70 with higher scores indicating greater flexibility.
|
Baseline, 6-8 weeks, 12 weeks
|
|
Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli
Time Frame: Baseline, 6-8 weeks, 12 weeks
|
Number of fixations on body and food related images presented during HF-HRV task.
|
Baseline, 6-8 weeks, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2024
Primary Completion (Actual)
May 7, 2025
Study Completion (Actual)
May 7, 2025
Study Registration Dates
First Submitted
November 1, 2022
First Submitted That Met QC Criteria
November 1, 2022
First Posted (Actual)
November 8, 2022
Study Record Updates
Last Update Posted (Actual)
July 6, 2026
Last Update Submitted That Met QC Criteria
June 9, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00111571
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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