protocolSection identificationModule nctId: NCT06364488, orgStudyIdInfo id: 295721, briefTitle: TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: BlueSkeye AI, class: INDUSTRY, collaborators name: Institute of Mental Health Nottingham, collaborators name: Nottinghamshire Healthcare NHS Trust, collaborators name: Nottingham University Hospitals NHS Trust, descriptionModule briefSummary: 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., conditionsModule conditions: Depression, conditions: Depression, Postpartum, conditions: Anxiety in Pregnancy, conditions: Anxiety, conditions: Anhedonia, conditions: Perinatal Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 125 participants, of whom 12 will enter the initial 5-month within-study pilot phase aimed at understanding any device-related adverse events and usability issues., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: TrueBlue App, outcomesModule primaryOutcomes measure: The rate of device related adverse events, secondaryOutcomes measure: Rate of initial use (assessing feasibility and acceptability), secondaryOutcomes measure: Rate of New Depression or Risk (Suicidality) events, secondaryOutcomes measure: Rate of referral to Perinatal Psychiatry services, secondaryOutcomes measure: Rate of acceptance of referrals to Perinatal Psychiatry, secondaryOutcomes measure: Diagnosis rate for depression, or other mental health problems, during the period of study., secondaryOutcomes measure: Continued use (acceptability), secondaryOutcomes measure: Loss to follow-up, secondaryOutcomes measure: Usability (quantitative measure), secondaryOutcomes measure: Agreement between TrueBlue generated score and validated scales, secondaryOutcomes measure: Thematic results, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nottingham University Hospitals NHS Trust, city: Nottingham, state: Nottinghamshire, zip: NG7 2UH, country: United Kingdom, contacts name: Nia Jones, role: CONTACT, email: Nia.Jones@nottingham.ac.uk, contacts role: CONTACT, email: TrueBlue@nottingham.ac.uk, contacts name: Nia Jones, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.9536, lon: -1.15047, locations facility: Nottinghamshire Healthcare NHS Foundation Trust, city: Nottingham, zip: NG3 6AA, country: United Kingdom, contacts name: Bonnie MILLAR, role: CONTACT, email: bonnie.millar@nottingham.ac.uk, contacts role: CONTACT, email: TrueBlue@nottingham.ac.uk, contacts name: Neil Nixon, MBBS, DM, role: PRINCIPAL_INVESTIGATOR, contacts name: Deepa Bagepalli Krishnan, role: SUB_INVESTIGATOR, contacts name: Zaib un Nisa, role: SUB_INVESTIGATOR, contacts name: Amy Au-Yong, role: SUB_INVESTIGATOR, contacts name: Christina Kelly, role: SUB_INVESTIGATOR, geoPoint lat: 52.9536, lon: -1.15047, hasResults: False