An interventional study of FlexED in Eating Disorders and Body Image, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.
Behavioral: FlexED
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.
Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5
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.
Time frame: Baseline, Week 4, Week 8, Week 12
Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)
A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Higher scores indicate greater flexibility/adaptability.
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Weight Concern Scale Score
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.
Time frame: Baseline, Week 8, Week 12
Change from Baseline in the Eating Disorder Examination - Questionnaire Short Form (EDE-Q-SF)
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.
Time frame: Baseline, Week 8, Week 12
Acceptability of the Intervention
Session completion rates
Time frame: 8 weeks
Plan to share: Yes — Data and data dictionaries will be made available at the time of publication.
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Duke University