[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640320":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":51,"collaborators":53,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":17,"enrollmentInfo":66,"targetDuration":17,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":82,"whyStopped":17,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Universidade do Porto","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"TIVA Intervention","EXPERIMENTAL","Behavioral: TIVA Mobile Application",[11],{"label":14,"type":15,"description":16,"interventionNames":17},"Usual Care","NO_INTERVENTION","Active Comparator",null,[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":17},"BEHAVIORAL","TIVA Mobile Application","The intervention consists of the use of the TIVA mobile application over a four-week period. The application was culturally adapted for Portuguese family caregivers and is based on Lluch's Positive Mental Health model. The app includes daily activities, motivational messages, relaxation exercises, psychoeducational content, and self-reflection strategies aimed at promoting positive mental health and well-being among family caregivers of older adults.",[9],[25],{"name":26,"affiliation":27,"role":28},"Sandra MT Carreira, PhD Student","Instituto de Ciências Biomédicas Abel Salazar","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":17,"email":33},"CONTACT","962189453","sandracarreira30@gmail.com",[35],{"facility":36,"status":17,"city":37,"state":38,"zip":17,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University of Porto","Porto","Porto District","Portugal","PT",{"type":42,"coordinates":43},"Point",[44,45],-8.61097,41.1485,{"lat":45,"lon":44},[48,49,50],{"name":26,"role":31,"phone":32,"phoneExt":17,"email":33},{"name":17,"role":31,"phone":17,"phoneExt":17,"email":33},{"name":26,"role":28,"phone":17,"phoneExt":17,"email":17},{"type":52,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[54],{"name":27,"class":6},"100640320","tiva-mobile-health-intervention-for-family-caregivers-100640320",false,"NCT07616284","TIVA Mobile Health Intervention for Family Caregivers","A Mobile Health Intervention for the Promotion of Mental Health in Family Caregivers: Protocol for a Pilot Study","TIVA-Pilot","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Unpaid family caregivers of a person with chronic illness, disability, or dependency.\n* Providing regular caregiving assistance for at least 4 months.\n* Living in Portugal.\n* Ability to read and understand Portuguese.\n* Ownership and use of a smartphone with internet access compatible with the TIVA mobile application.\n* Willingness to install and use the TIVA app for 4 weeks.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Severe cognitive impairment.\n* difficulties preventing independent use of the application or completion of study assessments.\n* Severe psychiatric disorder or acute mental health crisis interfering with participation.\n* Participation in another structured caregiver support or psychological intervention during the study period.\n* Inability to use a smartphone independently.",true,"ALL","18 Years",{"count":67,"type":68},80,"ESTIMATED","INTERVENTIONAL",[71],"NA","This pilot study aims to evaluate the feasibility, usability, and preliminary effects of the TIVA mobile health intervention in promoting positive mental health among family caregivers of older adults. TIVA is a culturally adapted mobile application based on Lluch's Positive Mental Health model and designed to support caregivers through daily activities, motivational messages, relaxation strategies, and psychoeducational content over a four-week intervention period.\n\nA pilot randomized controlled study with parallel allocation will be conducted involving family caregivers recruited in community and primary healthcare settings in Portugal. Participants will be allocated either to the TIVA intervention group or to a usual care control group. Outcomes will include positive mental health, caregiver burden, usability, satisfaction, adherence, and acceptability. Data will be collected at baseline, post-intervention, and follow-up.\n\nThis study intends to contribute to the development of accessible digital mental health strategies to support family caregivers and promote healthy ageing.",[74,75,76,77],"Positive Mental Health","Family Caregivers","Mental Health Promotion","Caregiver Burden",[79,75,74,80,76,81,77],"TIVA mHealth","Older Adults","Mobile Application","NOT_YET_RECRUITING","2026-05-29",{"date":85,"type":86},"2026-06-01","ACTUAL",{"date":88,"type":68},"2026-09",{"date":90,"type":68},"2027-04",{"name":5,"class":6},1]