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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07632248
Status
Recruiting
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Conditions

  • Body Image
  • Eating Disorders

Eligibility Criteria

Sex
ALL
Age
15 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • FlexED — BEHAVIORAL
    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.
  • Educational Control — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Jun 8, 2026
Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Jul 15, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: "FlexED"
    Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.
  • Active Comparator: Educational Control
    Seven 20-minute online education sessions about eating disorders.

Primary Outcome Measure

Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ) [ Time Frame: Baseline, 4, 8, 12, 24, 36, 48 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27705
Dottie R Mayo
[email protected]
919-668-1935
Rhonda M Merwin, Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Duke University· Durham, NC

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