Positive Mental HealthTIVA-PilotNCT07616284
TIVA Mobile Health Intervention for Family Caregivers
A study testing TIVA Mobile Application in people with Positive Mental Health and Family Caregivers, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Positive Mental Health, Family Caregivers, Mental Health Promotion
- What is being tested?
- TIVA Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
University of Porto
Porto, Porto District
Sandra MT Carreira, PhD Student, 962189453, sandracarreira30@gmail.com
sandracarreira30@gmail.com
About this study
Official title: A Mobile Health Intervention for the Promotion of Mental Health in Family Caregivers: Protocol for a Pilot Study
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.
Read the 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.
- Being tested
- TIVA Mobile Application
- Keywords
- TIVA mHealth, Family Caregivers, Positive Mental Health, Older Adults, Mental Health Promotion, Mobile Application, Caregiver Burden
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVA Mobile ApplicationBehavioural
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 group | Role | What they receive |
|---|---|---|
| TIVA Intervention | Experimental | Behavioral: TIVA Mobile Application Receives: Behavioral: TIVA Mobile Application |
| Usual Care | No intervention | Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: Baseline, post-intervention at 4 weeks, and 3-month follow-up
Secondary outcomes (1)
Caregiver Burden
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.
Measured: Baseline, post-intervention at 4 weeks, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Ciências Biomédicas Abel Salazar
- Responsible party
- Sponsor
- Investigators
- Sandra MT Carreira, PhD Student, Principal investigator, Instituto de Ciências Biomédicas Abel Salazar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616284
- Sponsor's protocol ID
- TIVA-PILOT-2026
- Acronym
- TIVA-Pilot
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to privacy, ethical, and data protection considerations. Aggregated study results may be made available upon reasonable request and in accordance with institutional and ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health Intervention for the Promotion of Mental Health in Family Caregivers: Protocol for a Pilot Study
- ClinicalTrials.gov ID
- NCT07616284
- Acronym / sponsor ID
- TIVA-Pilot / TIVA-PILOT-2026
- Keywords
- TIVA mHealth, Family Caregivers, Positive Mental Health, Older Adults, Mental Health Promotion, Mobile Application, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Instituto de Ciências Biomédicas Abel Salazar
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TIVA Intervention | Experimental | Behavioral: TIVA Mobile ApplicationBehavioral: TIVA Mobile Application |
| Usual Care | No intervention | –Active Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIVA Mobile ApplicationThe 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. | Behavioural | TIVA Intervention |
Primary outcome
Positive Mental Health
Time frame: 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]
1 secondary outcome
Caregiver Burden
Time frame: Baseline, post-intervention at 4 weeks, and 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to privacy, ethical, and data protection considerations. Aggregated study results may be made available upon reasonable request and in accordance with institutional and ethical regulations.
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Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra MT Carreira, PhD Student principal investigator
Instituto de Ciências Biomédicas Abel Salazar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIVA Mobile Application in people with Positive Mental Health and Family Caregivers, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra MT Carreira, PhD Student (962189453, sandracarreira30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Mental Health (time frame: Baseline, post-intervention at 4 weeks, and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.