[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614196":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":42,"collaborators":18,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":18,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":18,"enrollmentInfo":55,"targetDuration":18,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":71,"whyStopped":18,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Universidade Nova de Lisboa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 (Intervention group)","EXPERIMENTAL","Intervention group. Participants in the intervention group will be analysed according to their QOL scores and feedback on secondary conditions will be used for pooling and subgroup analyses. Participant in the intervention group will be determined through a randomised selection.",[13],"Other: Participation in digital mental health intervention and open peer support platform",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2 (control group)","NO_INTERVENTION","Participants in the control group, included as a result of randomised selection, will be put on the waitlist to access the Platform throughout the duration of the trial. The control group participants will be granted access to the Platform on day 31 of the trial. The introductory and closing evaluations will be performed on both groups at similar time points. This group is the waitlist group.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Participation in digital mental health intervention and open peer support platform","Participants in the experimental group will be immediately enrolled in the Platform and will have access to several interactive (daily mindfulness exercises; open dialogue group sessions; peer support forum; mentor chat) and passive (resource library: pre-recorded videos and guides) components for a total of 30 days, after which a final assessment will be performed on day 31. Control group participants will not be granted access to the Platform through the duration of the trial.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Dmitry Shamenkov","CONTACT","+351 910 825 243","ds.shamenkov@ensp.unl.pt",[31],{"facility":32,"status":18,"city":33,"state":18,"zip":18,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":18},"Nova University of Lisbon","Lisbon","Portugal","PT",{"type":37,"coordinates":38},"Point",[39,40],-9.1498,38.72509,{"lat":40,"lon":39},{"type":43,"investigatorFullName":26,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Dr.","100614196","effectiveness-of-the-dmhi-and-ops-platform-in-improving-participant-qol-a-randomised-controlled-trial-100614196",false,"NCT07276451","Effectiveness of the DMHI and OPS Platform in Improving Participant QOL: a Randomised Controlled Trial.","Effectiveness of the Digital Mental Health Intervention and Open Peer Support Platform in Improving Participant Quality of Life: a Randomised Controlled Trial.","Inclusion Criteria:\n\n* Aged ≥18 years;\n* No current clinical diagnosis of a mental health disorder;\n* No mental-health treatment or psychotropic medication initiated within the past 3 months;\n* Able to access the internet and provide informed consent.\n\nExclusion Criteria:\n\n* Current engagement with a mental health professional or therapy;\n* Inability to access the DMHI and OPS platform, or inability to provide informed consent;\n* PHQ-9 score ≥15 or GAD-7 score ≥15 at baseline (these participants will be referred to specialist services and excluded from further study participation)\n\nConfirmation of eligibility to participate. To comply with local regulations and ensure participant safety, a qualified and appropriately licensed specialist, affiliated with the institution will participate in screening of the participants recruitment results and carrying out decisions on whether to include or exclude the participant from the study based on degree of severity in the underlying psychological or psychiatric condition. The decision to exclude participants will be made based on safety considerations, need for emergency psychiatric help, compliance assumption and perceived efficacy.\n\nWithdrawal. Participation is voluntary. All enrolled participants are free to withdraw from the study at any time with or without notice to study personnel.\n\nRisk to self and\u002For others. During enrollment and study course, participants will be screened for severity of symptoms. If our participating specialist identifies a risk to self or others, appropriate actions will be taken to contact the authorities and local law representatives according to European and Local Law.\n\nSample size estimates. For two groups and a dichotomous endpoint (improvement or no improvement) and an anticipated incidence of 45% in the intervention group and 75% in the control group, at a 95% confidence level and 5% margin of error, power of 80% and enrolment ratio of 1, a sample size of 82 participants was chosen for this RCT (41 in intervention group, 41 in control group).",true,"ALL","18 Years",{"count":56,"type":57},82,"ESTIMATED","INTERVENTIONAL",[60],"NA","RCT to evaluate the efficacy of a digital mental health intervention platform with open peer support in improving participant quality of life.",[63,64,65],"Anxiety","Depression and Quality of Life","Quality of Life",[67,68,69,70],"digital mental health intervention","open peer support","mental health","online support","NOT_YET_RECRUITING","2025-11-28",{"date":74,"type":75},"2025-12-11","ACTUAL",{"date":77,"type":57},"2026-01-01",{"date":79,"type":57},"2026-09",{"name":5,"class":6},1]