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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
Who can join
Ages 15 to 25 · All sexes
Full eligibility criteria
Inclusion Criteria: * Female between the age of 15-25 years old. * Weight Concerns Scale score of \>=47. * Endorses one or more eating disorder behaviors (e.g., extreme dieting or exercise, subjective or objective binge eating, purging behaviors). Exclusion Criteria: * Currently meets the DSM-5 diagnostic criteria for full threshold anorexia nervosa, bulimia nervosa or binge eating disorder, or for an eating or feeding disorder that does not include body-image or weight related distress and is not the focus of study (e.g., ARFID, PICA) or a past diagnosis of one of these disorders. * Change in psychotropic medications in the past month. * Active suicidal ideation, current substance use disorder or diagnosed psychotic disorder. * Bipolar disorder not being treated with medication. * Currently in treatment for an eating disorder. * Non-English speaking.
About the study
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.
What is being tested
- FlexED (behavioral)
- Educational Control (behavioral)
Sponsor: Duke University · Participants: 128 · Started: Jun 15, 2026
Contact the study team
- Rhonda M Merwin, Ph.D. · Phone: 919-681-7231
- Dottie R Mayo · Phone: 919-668-1935
Official record on ClinicalTrials.gov — NCT07632248
Locations in the U.S.
| North Carolina | Duke University, Durham |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.