CompletedNot Applicable

FlexED: A Digital, Gamified Early Intervention for Eating Disorders

United States34 participantsStarted 2024-06-01

Plain-language summary

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.

Who can participate

Age range

15 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)

Timeframe: Baseline, 6-8 weeks and 12 weeks

High Frequency Heart Rate Variability (HF-HRV)

Timeframe: Baseline, 6-8 weeks, and 12 weeks

Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli

Timeframe: Baseline, 6-8 weeks, and 12 weeks

CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)

Timeframe: Baseline, 6-8 weeks, 12 weeks

Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli

Timeframe: Baseline, 6-8 weeks, 12 weeks

Trial details

NCT IDNCT05609409

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-07

Results submitted2026-04-24

View on ClinicalTrials.gov More Eating Disorders trials

Plain-language summary

Who can participate

Age range

15 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)

Timeframe: Baseline, 6-8 weeks and 12 weeks

High Frequency Heart Rate Variability (HF-HRV)

Timeframe: Baseline, 6-8 weeks, and 12 weeks

Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli

Timeframe: Baseline, 6-8 weeks, and 12 weeks

CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)

Timeframe: Baseline, 6-8 weeks, 12 weeks

Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli

Timeframe: Baseline, 6-8 weeks, 12 weeks