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FlexED: A Digital, Gamified Early Intervention for Eating Disorders

NCT05609409 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-07-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Cyprus

    collaborator OTHER

  • Duke University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-05-07
Completion
2025-05-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05609409 on ClinicalTrials.gov