[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571479":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":45,"collaborators":49,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":21,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":24,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Bordeaux","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Game play","ACTIVE_COMPARATOR","Participants receive an email with the link to book a slot to play the Escape Game. The date when students can play the Escape Game is defined when 4 students are available at the same slot. Students receive a further email with all the instructions to play the game.",[13],"Other: EscapeCovid",{"label":15,"type":16,"description":17,"interventionNames":18},"email on mental health-related information","PLACEBO_COMPARATOR","Students receive an email detailing mental health services and describing the most common mental health problems. Participants are randomized so that the two groups are similar in terms of sex, age and field of study (stratified balanced randomization).",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"EscapeCovid","Online Escape Game with 4 players and a game guide. The players, in a group, must solve enigmas to win.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Ilaria Montagni Lecturer-researcher, PhD","CONTACT","00330642193363","ilaria.montagni@u-bordeaux.fr",[32],{"facility":33,"status":34,"city":35,"state":24,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":24},"Bordeaux Population Health U1219","RECRUITING","Bordeaux","33000","France","FR",{"type":40,"coordinates":41},"Point",[42,43],-0.58046,44.84124,{"lat":43,"lon":42},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Montagni Ilaria","Lecturer-researcher",[50,53],{"name":51,"class":52},"David Labrosse","UNKNOWN",{"name":54,"class":52},"Clara Vié","100571479","cocreation-and-evaluation-of-an-escape-game-on-students-mental-health-100571479",false,"NCT06720792","Cocreation and Evaluation of an Escape Game on Students' Mental Health","An Escape Game to Promote Students' Mental Health Outcomes in the Aftermaths of Covid-19 Pandemic: Protocol for a Randomized Controlled Trial Evaluating a Cocreated Intervention","Inclusion Criteria:\n\n* university students\n* understanding and speaking French\n* being aged more than 18 years old\n\nExclusion Criteria:\n\n* not enrolled in a French university\n* minor\n* not understanding and speaking French\n* not having given one's electronic consent",true,"ALL","18 Years",{"count":66,"type":67},191,"ESTIMATED","INTERVENTIONAL",[70],"NA","The Covid-19 pandemic and the protracted lockdowns have heavily impacted university students' mental health. Digital Escape Games represent a good means to reach students and propose them solutions for their psychological well-being.\n\nThe objective of the study is to evaluate a cocreated digital Escape Game on students' mental health in the Covid-19 era. The evaluation of the effectiveness of this stand-alone intervention concerns mental health outcomes (mental health literacy, appraisal and change of beliefs about mental health, recognition and management of emotions, and positive coping strategies) and the appreciation and relevance of the game.\n\nA randomized controlled trial with pre- and post-test data collection (online questionnaires with validated scales) will be conducted among 500 students in Bordeaux, France, to evaluate a game cocreated with students, researchers, health professionals and web-developers. A sub-sample of students will be randomly selected for responding to a semi-structured interview following a mixed methods design. Recruitment will be done through mail invitation from student associations and presentations in university classes. Half of the sample (250 students) will play the Escape Game, while the other half will receive an email with mental health-related information. The whole study is carried out online.\n\nAs of December 2nd 2024, 191 students have answered the baseline questionnaire (90 intervention vs. 101 control). Twenty-three students have played the Escape Game and 53 are in the control arm. The current sample size is too small for reaching significance level. Among participants, 20 were interviewed (10 intervention vs. 10 control) reaching the saturation of the sample. According to preliminary results, the game has proved a positive impact on all defined outcomes, while the email has been effective in increasing knowledge on resources available and on coping strategies and meditation techniques. We expect the trial to be completed by the end of June 2025.\n\nPreliminary results from the qualitative sub-study are promising: in the aftermaths of the Covid-19 crisis, this intervention is intended to promote players' mental health through gamification, knowledge transfer and a learning-by-doing approach.",[73],"Mental Health",[75,76,77,78,79],"cocreation","evaluation","randomised controlled trial","students","mental health","2024-12-02",{"date":82,"type":83},"2024-12-06","ACTUAL",{"date":85,"type":83},"2022-01-01",{"date":87,"type":67},"2025-12-31",{"name":5,"class":6},1]