FlexED: National Substudy

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07807774
Status
Recruiting
Apply to this trial

Conditions

  • Body Image
  • Eating Disorders

Eligibility Criteria

Sex
ALL
Age
18 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.

Study Details

The purpose of this study is to test the feasibility of disseminating an intervention broadly. "FlexED" is a digital gamified intervention targeting 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 complete seven 20-minute sessions of the intervention using their smartphone over about 8 weeks. Participants also complete questionnaires bi-weekly as they go through the intervention. A final measurement is taken one month after the last digital intervention session. These surveys are all conducted online. Participants are in the study for up to 12 weeks.

Key Dates

First listed
Sep 8, 2026
Start date
Aug 24, 2026
Status verified
Sep 2026
Primary completion
Jul 15, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
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.

Primary Outcome Measure

Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5 [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27705
Dottie R Mayo
[email protected]
919-668-1935
Rhonda M Merwin, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Duke University Medical Center· Durham, NC

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