NCT05609409

FlexED: A Digital, Gamified Early Intervention for Eating Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 15 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The goal of this multiple baseline experiment is to test the effect of a digital, gamified early intervention for eating disorders on body image flexibility and determine treatment dose. Twenty-four young women and girls (between the ages of 15-25) with eating disorder (ED) symptoms will be randomized to different baseline durations (varying between 2-6 weeks). Participants will complete eight 20-30 minute sessions of a multimedia application over 10 weeks using their home computer or mobile device. Body Image Flexibility (BIF) will be measured repeatedly using a multimodal assessment strategy (behavior, physiological and self-report) during baseline and treatment phases. The investigators will estimate the effect of the intervention on BIF and examine when change occurs and plateaus (with no discernable benefit for additional sessions) to determine treatment dose.

Conditions

• Eating Disorders
• Body Image

Interventions

Type	Name	Description
BEHAVIORAL	FlexED	Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-05-07
• Completion: 2025-05-07
• First posted: 2022-11-08
• Last updated: 2025-07-04

Locations

1 site across 1 country: United States