RecruitingNot ApplicableNCT07632248

A Randomized Controlled Trial Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")

A Randomized Controlled Trial Testing Mechanism Engagement and Clinical Impact of FlexED: A Digital, Gamified Early Intervention for Eating Disorders


Sponsor

Duke University

Enrollment

128 participants

Start Date

Jun 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test whether a new digital intervention decreases eating disorder symptoms in young women and girls at risk by changing how they experience thoughts and feelings about their body. The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants will be randomly assigned (like a coin toss) to either the new digital intervention or education modules completed online. The main questions are: Does the digital intervention change how participants experience thoughts and feelings about their body or how they react to eating disorder triggers (e.g., images of idealized bodies)? Do these changes lead to decreases in eating disorder symptoms? Is the intervention acceptable and at the right dose? Participants will: Complete seven brief digital sessions over about 8 weeks. Complete interviews, surveys and lab assessments of reaction to body-related words and images. Participants are followed for about 1 year.


Eligibility

Min Age: 15 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Educational Control and a behavioral approach called FlexED for people with body image and eating disorders. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALFlexED

Intervention consists of seven 20-minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn psychological flexibility skills for body-image distress by completing interactive exercises and games with a relatable character and story line and receive rewards that reinforce learning.

BEHAVIORALEducational Control

Intervention consists of seven digital online sessions of education about eating disorders and body image. Participants read information about how eating disorders develop and their impact on health and well-being and body image, watch videos and complete quizzes to check knowledge.


Locations(1)

Duke University

Durham, North Carolina, United States

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NCT07632248


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