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

RecruitingNAAges 15 Years - 25 YearsAllDuke University
NCT07632248 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 reacti

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📋 Eligibility rules (as published)
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.
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What it tests

  • FlexED
  • Educational Control
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Where

1 site
Duke University
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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