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FlexED: National Substudy

FlexED: A Digital Gamified Early Intervention for Eating Disorders

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07807774
Enrollment
100
Registered
2026-09-08
Start date
2026-08-24
Completion date
2028-07-31
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Image, Eating Disorders

Keywords

Body Image Flexibility, Eating Disorders, Acceptance and Commitment Therapy, Psychological Flexibility, Early Intervention

Brief summary

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.

Interventions

BEHAVIORALFlexED

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.

Sponsors

Duke University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* Female between the age of 18-25 years old.

Exclusion criteria

* Non-English speaking

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5Baseline, Week 4, Week 8, Week 12Self-report measure of body-image psychological flexibility. The measure consists of 5 items that ask about the degree to which thoughts and feelings about the body interfere with living. Higher scores indicate greater flexibility/adaptability.
Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)Baseline, Week 4, Week 8, Week 12A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Higher scores indicate greater flexibility/adaptability.
Change in Weight Concern Scale ScoreBaseline, Week 8, Week 125-item measure of weight concerns (worry about weight, fear of weight gain, dieting history, importance of weight, fear of fatness). Elevated scores have been associated with the development of eating disorders.
Change from Baseline in the Eating Disorder Examination - Questionnaire Short Form (EDE-Q-SF)Baseline, Week 8, Week 12Questionnaire format of the clinician-administered interview assessing eating disorder symptom severity, producing a Global score (main outcome) and 4 Subscale scores: Restraint, Eating Concerns, Weight Concerns, Shape Concerns. Higher scores indicate greater symptomatology.
Acceptability of the Intervention8 weeksSession completion rates

Countries

United States

Contacts

CONTACTDottie R Mayo
drm72@duke.edu919-668-1935
PRINCIPAL_INVESTIGATORDottie R Mayo

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026