[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544100":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":80,"collaborators":82,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":20,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":20,"enrollmentInfo":98,"targetDuration":20,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":112,"overallStatus":59,"whyStopped":20,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"BlueSkeye AI","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Device Related Adverse Events","OTHER","The primary aim of the study is to demonstrate that use of the TrueBlue app to monitor depression is safe",[13],"Device: TrueBlue App",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","TrueBlue App","The use of the TrueBlue App, to generate automated measures of mood that can be assessed for agreement with validated clinical scales eg. PHQ9.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Neil Nixon, MBBS","School of Medicine, University of Nottingham and Nottinghamshire Healthcare NHS Trust","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"John Michaelis, BSc","CONTACT","01689 856664","john@blueskeye.com",{"name":23,"role":29,"phone":33,"phoneExt":20,"email":34},"0115 969 1300","Neil.Nixon@nottshc.nhs.uk",[36,57],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Nottingham University Hospitals NHS Trust","NOT_YET_RECRUITING","Nottingham","Nottinghamshire","NG7 2UH","United Kingdom","UK",{"type":45,"coordinates":46},"Point",[47,48],-1.15047,52.9536,{"lat":48,"lon":47},[51,54,56],{"name":52,"role":29,"phone":20,"phoneExt":20,"email":53},"Nia Jones","Nia.Jones@nottingham.ac.uk",{"name":20,"role":29,"phone":20,"phoneExt":20,"email":55},"TrueBlue@nottingham.ac.uk",{"name":52,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":58,"status":59,"city":39,"state":20,"zip":60,"country":42,"countryCode":43,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Nottinghamshire Healthcare NHS Foundation Trust","RECRUITING","NG3 6AA",{"type":45,"coordinates":62},[47,48],{"lat":48,"lon":47},[65,68,69,71,74,76,78],{"name":66,"role":29,"phone":20,"phoneExt":20,"email":67},"Bonnie MILLAR","bonnie.millar@nottingham.ac.uk",{"name":20,"role":29,"phone":20,"phoneExt":20,"email":55},{"name":70,"role":25,"phone":20,"phoneExt":20,"email":20},"Neil Nixon, MBBS, DM",{"name":72,"role":73,"phone":20,"phoneExt":20,"email":20},"Deepa Bagepalli Krishnan","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":20,"phoneExt":20,"email":20},"Zaib un Nisa",{"name":77,"role":73,"phone":20,"phoneExt":20,"email":20},"Amy Au-Yong",{"name":79,"role":73,"phone":20,"phoneExt":20,"email":20},"Christina Kelly",{"type":81,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[83,85,88],{"name":84,"class":10},"Institute of Mental Health Nottingham",{"name":86,"class":87},"Nottinghamshire Healthcare NHS Trust","OTHER_GOV",{"name":37,"class":10},"100544100","trueblue-clinical-study---investigating-the-use-of-a-mobile-phone-app-trueblue-for-monitoring-depression-and-anxiety-100544100",false,"NCT06364488","TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety","Inclusion Criteria:\n\n\\- 18 years or older\n\n* Fluent in spoken and written English\n* Has capacity to provide consent\n* At least 12 weeks pregnant or less than 12 weeks postpartum\n* Access to internet connectivity\n* Access to a compatible smart phone device (for up to 10 participants, where needed through not having a personal device, this access may be provided through the study team).\n* Has a current GP within Nottinghamshire\n\nExclusion Criteria:\n\n* ● Current clinically diagnosed psychiatric disorder other than depression\n\n  * Previous history of a clinically diagnosed psychiatric disorder, other than depression and generalised anxiety disorder (including previous Psychosis, Bipolar Disorder, Personality Disorder, Substance Abuse Disorders, Eating Disorders)\n  * Clinical diagnosis of an Autistic Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Parkinson's Disease or other current Neurological Disorder.",true,"FEMALE","18 Years",{"count":99,"type":100},125,"ESTIMATED","INTERVENTIONAL",[103],"NA","This trial will assess the safety, feasibility, acceptability, usability and agreement with validated scales of an automated mood monitoring App (TrueBlue), in adult, perinatal participants (recruited between 12 weeks of pregnancy and 12 weeks post-partum), recruited across multiple sites in Nottinghamshire, United Kingdom (UK). An initial within-study pilot phase will assess key aspects of the study including recruitment rate, usability issues and a detailed understanding of any device related adverse events; prior to full recruitment of a total 125 participants over a total 14-month period.",[106,107,108,109,110,111],"Depression","Depression, Postpartum","Anxiety in Pregnancy","Anxiety","Anhedonia","Perinatal Depression",[106,109,113],"Perinatal","2025-09-16",{"date":116,"type":117},"2025-09-19","ACTUAL",{"date":119,"type":117},"2024-10-01",{"date":121,"type":100},"2026-12-30",{"name":5,"class":6},2]