TIVA Mobile Health Intervention for Family Caregivers

NCT07616284 | Not Yet Recruiting

• 1 other identifier: TIVA-PILOT-2026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Positive Mental Health; Family Caregivers; Mental Health Promotion; Caregiver Burden

Keywords

TIVA mHealth; Family Caregivers; Positive Mental Health; Older Adults; Mental Health Promotion; Mobile Application; Caregiver Burden

Outcome Measures

Primary Outcomes (1)

• Positive Mental Health

  Positive Mental Health assessed using the Positive Mental Health Questionnaire (PMHQ). The PMHQ total score ranges from 39 to 156, with higher scores indicating better positive mental health, emotional well-being, autonomy, interpersonal relationship skills, self-control, and problem-solving ability. Lower scores indicate lower levels of positive mental health. \[Time Frame: Baseline, post-intervention at 4 weeks, and 3-month follow-up\]

  Baseline, post-intervention at 4 weeks, and 3-month follow-up

Secondary Outcomes (1)

• Caregiver Burden

  Baseline, post-intervention at 4 weeks, and 3-month follow-up

Other Outcomes (4)

• Usability of the TIVA Mobile Application

  Post-intervention at 4 weeks

• Satisfaction With the TIVA Mobile Application

  Post-intervention at 4 weeks.

• Adherence

  During the 4-week intervention period.

Study Arms (2)

TIVA Intervention

EXPERIMENTAL

Behavioral: TIVA Mobile Application

Behavioral: TIVA Mobile Application

Usual Care

NO INTERVENTION

Active Comparator

Interventions

TIVA Mobile Application BEHAVIORAL

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.

TIVA Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead
• Instituto de Ciências Biomédicas Abel Salazar: collaborator

Study Sites (1)

University of Porto

Porto, Porto District, Portugal

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Sandra MT Carreira, PhD Student

  Instituto de Ciências Biomédicas Abel Salazar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra MT Carreira, PhD Student

CONTACT

962189453; sandracarreira30@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants and researchers will be aware of group allocation due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the TIVA intervention group or the usual care control group. The intervention group will use the TIVA mobile application for four weeks, while the control group will receive usual care. Outcomes will be assessed at baseline, post-intervention, and follow-up.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)