Duke University Medical Center
Durham, North Carolina, 27705, United States
Location status: Recruiting
NCT Number: NCT07807774
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.
Interested in participating?
Request Info18 year–25 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27705, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Time frame: 8 weeks
Session completion rates
Contact information is provided by the study sponsor or research team.
Duke University
Other
FlexED: A Digital Gamified Early Intervention for Eating Disorders
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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