[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637234":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":47,"locations":56,"responsibleParty":67,"collaborators":52,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":52,"enrollmentInfo":80,"targetDuration":52,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":98,"whyStopped":52,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University Hospital, Akershus","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Tankevirus app","ACTIVE_COMPARATOR","Tankevirus is a brief, CBT-based psychoeducative app running over approximately 2 weeks. Content is provided in the form of videos with daily reminders. The version to be used is an update of the existing app, expected to be complete by May 2027.",[13],"Other: Tankevirus",{"label":15,"type":10,"description":16,"interventionNames":17},"Grubl app","Grubl is a brief, metacognitive therapy based psychoeducative app running over approximately 2 weeks. Content is provided in the form of videos with daily reminders.",[18],"Other: Grubl",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo app","PLACEBO_COMPARATOR","The placebo \u002F sham app will have structural elements largely matching Tankevirus and Grubl; providing a programme of approximately 2 weeks. The app will present information on attention control training as a method for reducing problems with anxiety and depression. While attention control training can be effective for this purpose, the app will only provide very brief (a few minutes) of daily attention-demanding miniature games, that are expected to have zero or negligible impact on anxiety or depression. Full details on the placebo arm setup including screenshots etc. will be provided alongside the registered report publication.",[24],"Other: Placebo Application",[26,32,38],{"type":6,"name":27,"description":11,"armGroupLabels":28,"otherNames":29},"Tankevirus",[9],[30,31],"CBT-based self-help","Psychoeducation",{"type":6,"name":33,"description":16,"armGroupLabels":34,"otherNames":35},"Grubl",[15],[36,37,31],"Self-help","Meta-cognitive therapy",{"type":6,"name":39,"description":22,"armGroupLabels":40,"otherNames":41},"Placebo Application",[20],[42],"Sham application",[44],{"name":45,"affiliation":5,"role":46},"Julia M Delor, PhD","PRINCIPAL_INVESTIGATOR",[48,54],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Kim Rand, PhD","CONTACT","004740220366",null,"Kim.rand@ahus.no",{"name":45,"role":50,"phone":52,"phoneExt":52,"email":55},"julia.menichetti.delor@ahus.no",[57],{"facility":58,"status":52,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":52,"geoPoint":52,"contacts":64},"Akershus University Hospital","Lørenskog","Akershus","1978","Norway","NO",[65],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":66},"kim.rand@ahus.no",{"type":46,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"Kim Rand","Senior Researcher","100637234","mental-health-intervention-with-digital-applications-mind-app-randomized-controlled-researcher-blinded-trial-evaluating-the-effectiveness-of-the-tankevirus-and-grubl-mental-health-apps-100637234",false,"NCT07627204","Mental Health INtervention With Digital APPlications (MIND-APP): Randomized Controlled Researcher Blinded Trial Evaluating the Effectiveness of the Tankevirus and Grubl Mental Health Apps","App-Based Mental Health Interventions for Anxiety and Depression: Protocol for the MIND-APP Randomized Controlled Trial","MIND-APP","Inclusion Criteria:\n\n* Adults and adolescents aged 16 years or older (16 is the minimum age of consent without parental approval for participation in research in Norway. Inclusion of individuals aged younger than 18 years will be highlighted in the ethical review.)\n* Residing in Norway\n* Access to a compatible smartphone (iOS or Android)\n* Reporting mild to moderately severe symptoms of anxiety and\u002For depression (Patient Health Questionnaire-9 \\[PHQ-9\\] score ≥5 and\u002For Generalized Anxiety Disorder-7 \\[GAD-7\\] ≥5)\n* Able to read Norwegian and use Norwegian to a sufficient level\n* Able and willing to provide consent for the study prior to participation\n\nExclusion Criteria:\n\n* PHQ-9 score ≥20 (severe depression)\n* Active suicidal ideation (PHQ-9 item 9 score ≥2)\n* Have ever required hospitalization for mental illness or are currently taking antipsychotic or other psychotropic medications\n* Current engagement in psychological treatment\n* Report having used Tankevirus or Grubl apps in the past","ALL","16 Years",{"count":81,"type":82},1000,"ESTIMATED","INTERVENTIONAL",[85],"NA","The MIND-APP trial is a 3-arm randomized controlled trial (1:1:1 allocation) conducted fully remotely via a bespoke smartphone research platform. A total of 1000 Norwegian residents aged 16 years or older with mild to moderate symptoms of anxiety and\u002For depression will be recruited through national digital outreach. Coprimary outcomes are changes in anxiety (Generalized Anxiety Disorder-7) and depression (Patient Health Questionnaire-9) scores from baseline to postintervention (2-4 weeks). Secondary outcomes include health-related quality of life (EQ-5D-5L), quality-adjusted life years accrued over 6 months, functional impairment (Work and Social Adjustment Scale), health care resource use, and adverse events. Incremental cost-effectiveness ratios for Tankevirus and Grubl relative to placebo will be estimated from the perspective of public health services.",[88,89],"Anxiety","Depression",[88,89,91,92,93,94,95,62,96,97],"Cognitive Behavioral Therapy","CBT","cost-effectiveness","digital health","metacognitive therapy","QALY","Application","NOT_YET_RECRUITING","2026-06-01",{"date":101,"type":102},"2026-06-04","ACTUAL",{"date":104,"type":82},"2027-08-15",{"date":106,"type":82},"2028-03-31",{"name":5,"class":6},1]