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Behavioral Intervention

Digital Game Intervention for Eating Disorders

N/A
Recruiting
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female identified 15-25 years old
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the impact of a digital game-like intervention for eating disorders on body image flexibility in young women and girls aged 15-25. Participants will undergo different baseline periods before completing eight

Who is the study for?
This trial is for young women and girls aged 15-25 who are experiencing symptoms of eating disorders. They should be concerned about their weight (scoring over 47 on a specific scale) and have started unhealthy weight control behaviors within the last three years.
What is being tested?
The FlexED program, a digital game-like intervention designed to help with eating disorders, is being tested. Participants will use an app for eight sessions over ten weeks to see if it improves how they view their body image.
What are the potential side effects?
Since this is a digital intervention focusing on mental health therapy through an application, traditional physical side effects are not expected. However, participants may experience emotional discomfort or distress related to confronting eating disorder issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a female aged between 15 and 25.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in High Frequency Heart Rate Variability (HF-HRV)
Change in biased processing of body image stimuli relative to neutral stimuli
Change in body image flexibility as indexed by the Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Digital InterventionExperimental Treatment1 Intervention
Eight 20-30 minute sessions of an online, multimedia application

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Who is running the clinical trial?

Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,981,523 Total Patients Enrolled
University of CyprusOTHER
27 Previous Clinical Trials
10,604 Total Patients Enrolled
~16 spots leftby Dec 2025
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