NCT07632248 A Randomized Controlled Trial Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")
| NCT ID | NCT07632248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Eating Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2028-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2026-06-15 with a primary completion date of 2028-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07632248 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 25 Years, studying Eating Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07632248 currently recruiting?
Yes, NCT07632248 is actively recruiting participants. Contact the research team at rhonda.merwin@duke.edu for enrollment information.
Where is the NCT07632248 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07632248 clinical trial?
NCT07632248 is sponsored by Duke University. The trial plans to enroll 128 participants.