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NCT Number: NCT07807774

FlexED: National Substudy

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Dottie R Mayo

CONTACT

[email protected]

919-668-1935

Rhonda M Merwin, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non-English speaking

Treatment and study plan

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.

Primary outcomes

  1. Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5

    Time frame: Baseline, Week 4, Week 8, Week 12

    Self-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.

  2. Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)

    Time frame: Baseline, Week 4, Week 8, Week 12

    A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Higher scores indicate greater flexibility/adaptability.

  3. Change in Weight Concern Scale Score

    Time frame: Baseline, Week 8, Week 12

    5-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.

  4. Change from Baseline in the Eating Disorder Examination - Questionnaire Short Form (EDE-Q-SF)

    Time frame: Baseline, Week 8, Week 12

    Questionnaire 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.

  5. Acceptability of the Intervention

    Time frame: 8 weeks

    Session completion rates

Study contacts

Contact information is provided by the study sponsor or research team.

Dottie R Mayo

CONTACT

[email protected]

919-668-1935

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

FlexED: A Digital Gamified Early Intervention for Eating Disorders

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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