[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655061":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":34,"interventions":41,"overallOfficials":46,"centralContacts":50,"locations":55,"responsibleParty":74,"collaborators":76,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":27,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":27,"studyType":93,"phases":94,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":58,"whyStopped":27,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":27},[9,13,16,20,23],{"measure":10,"description":11,"timeFrame":12},"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. Scores range from 5-35, with higher scores indicating greater flexibility\u002Fadaptability.","Baseline, Week 4, Week 8, Week 12",{"measure":14,"description":15,"timeFrame":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. Openness scores range from 0-18, Awareness 0-18, and Engagement 0-24. Higher scores indicate greater flexibility\u002Fadaptability.",{"measure":17,"description":18,"timeFrame":19},"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). Scores range from 0-100, with elevated scores (scores \\>= 47) having been associated with an increased risk of developing an eating disorder.","Baseline, Week 8, Week 12",{"measure":21,"description":22,"timeFrame":19},"Change from Baseline in the Eating Disorder Examination Questionnaire - Short (EDE-QS)","Short questionnaire format (12 items) of the clinician-administered interview assessing eating disorder symptom severity. Scores range from 0-36, with higher scores indicating greater symptomatology.",{"measure":24,"description":25,"timeFrame":26},"Acceptability of the Intervention","Session completion rates","8 weeks",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"NA","SINGLE_GROUP","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"FlexED","EXPERIMENTAL","Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.",[40],"Behavioral: FlexED",[42],{"type":43,"name":36,"description":44,"armGroupLabels":45,"otherNames":27},"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.",[36],[47],{"name":48,"affiliation":5,"role":49},"Dottie R Mayo","PRINCIPAL_INVESTIGATOR",[51],{"name":48,"role":52,"phone":53,"phoneExt":27,"email":54},"CONTACT","919-668-1935","drm72@duke.edu",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Duke University Medical Center","RECRUITING","Durham","North Carolina","27705","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-78.89862,35.99403,{"lat":68,"lon":67},[71,72],{"name":48,"role":52,"phone":53,"phoneExt":27,"email":54},{"name":73,"role":49,"phone":27,"phoneExt":27,"email":27},"Rhonda M Merwin, PhD",{"type":75,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[77],{"name":78,"class":79},"National Institute of Mental Health (NIMH)","NIH","100655061","flexed-national-substudy-100655061",false,"NCT07807774","FlexED: National Substudy","FlexED: A Digital Gamified Early Intervention for Eating Disorders","Inclusion Criteria:\n\n* Female between the age of 18-25 years old.\n\nExclusion Criteria:\n\n* Non-English speaking","ALL","18 Years","25 Years",{"count":91,"type":92},100,"ESTIMATED","INTERVENTIONAL",[29],"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).\n\nParticipants 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.",[97,98],"Eating Disorders","Body Image",[100,97,101,102,103],"Body Image Flexibility","Acceptance and Commitment Therapy","Psychological Flexibility","Early Intervention","2026-10-02",{"date":106,"type":107},"2026-10-07","ACTUAL",{"date":109,"type":107},"2026-08-24",{"date":111,"type":92},"2028-07-31",{"name":5,"class":6},1]