TIVA Mobile Health Intervention for Family Caregivers (TIVA-Pilot)

Universidade do Porto

Status

Begins enrollment in 2 months

Conditions

Caregiver Burden

Family Caregivers

Positive Mental Health

Mental Health Promotion

Treatments

Behavioral: TIVA Mobile Application

Study type

Interventional

Funder types

Other

Identifiers

NCT07616284

TIVA-PILOT-2026

Details and patient eligibility

About

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.

Full description

This pilot randomized controlled trial aims to evaluate the feasibility, usability, acceptability, and preliminary effects of the TIVA mobile health intervention designed to promote positive mental health among family caregivers of older adults.

The TIVA intervention is a culturally adapted mobile application based on Lluch's Positive Mental Health model and derived from the Spanish "Cuidadoras Crónicos" program. The intervention includes daily psychoeducational content, motivational messages, relaxation exercises, and activities focused on emotional well-being, autonomy, interpersonal relationships, problem-solving, and self-care over a four-week period.

Family caregivers will be recruited from community and primary healthcare settings in Portugal. Eligible participants will be randomly allocated in a 1:1 ratio to either the intervention group (TIVA app plus usual care) or the control group (usual care only). Due to the nature of the intervention, participant blinding will not be feasible.

Data collection will occur at baseline (T0), immediately after the intervention period (T1), and at follow-up (T2). Outcomes will include positive mental health, caregiver burden, usability, satisfaction, adherence, and acceptability. Positive mental health will be assessed using the Positive Mental Health Questionnaire, and caregiver burden will be evaluated using the Zarit Burden Interview.

This study seeks to contribute to the development of accessible digital mental health strategies for family caregivers and to support healthy ageing policies and community-based care.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.