Caregiver Burden, Family Caregivers, Mental Health Promotion, Positive Mental Health
Conditions
Keywords
TIVA mHealth, Family Caregivers, Positive Mental Health, Older Adults, Mental Health Promotion, Mobile Application, Caregiver Burden
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.
Detailed 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.
Interventions
BEHAVIORALTIVA 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.
Sponsors
Universidade do Porto
Instituto de Ciências Biomédicas Abel Salazar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This is an open-label study. Participants and researchers will be aware of group allocation due to the nature of the intervention.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Mental Health | Baseline, post-intervention at 4 weeks, and 3-month follow-up | 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. \[Time Frame: Baseline, post-intervention at 4 weeks, and 3-month follow-up\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Burden | Baseline, post-intervention at 4 weeks, and 3-month follow-up | Caregiver burden assessed using the Zarit Burden Interview (ZBI). Total scores range from 0 to 88, with higher scores indicating higher levels of perceived caregiver burden, stress, and emotional overload associated with the caregiving role. |
Countries
Portugal
Contacts
CONTACTSandra MT Carreira, PhD Student
PRINCIPAL_INVESTIGATORSandra MT Carreira, PhD Student
Instituto de Ciências Biomédicas Abel Salazar
Outcome results
None listed