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Clinical Trials in Portugal / NCT07616284
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TIVA Mobile Health Intervention for Family Caregivers

NCT07616284 · tracked via the Priya Life Science Portugal tracker
Phase
Not applicable
Started
2026-09
Last updated
2026-06-01

Condition(s) studied

Positive Mental HealthFamily CaregiversMental Health PromotionCaregiver Burden

Investigational drug(s) / intervention(s)

TIVA Mobile Application

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.

Study summary

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.

A 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.

This study intends to contribute to the development of accessible digital mental health strategies to support family caregivers and promote healthy ageing.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Adults aged 18 years or older. * Unpaid family caregivers of a person with chronic illness, disability, or dependency. * Providing regular caregiving assistance for at least 4 months. * Living in Portugal. * Ability to read and understand Portuguese. * Ownership and use of a smartphone with internet access compatible with the TIVA mobile application. * Willingness to install and use the TIVA app for 4 weeks. * Ability to provide informed consent. Exclusion Criteria: * Severe cognitive impairment. * difficulties preventing independent use of the application or completion of study assessments. * Severe psychiatric disorder or acute mental health crisis interfering with participation. * Participation in another structured caregiver support or psychological intervention during the study period. * Inability to use a smartphone independently.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of Porto Porto Porto District

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07616284 on ClinicalTrials.gov ↗ ← All trials in Portugal