NCT07577440 · ACTIVE NOT RECRUITING
Effectiveness of the Self-Control Module of a Positive Mental Health Promotion Programme for Adult Informal Caregivers of People With Dementia: Protocol for a Randomised Controlled Trial
Sponsor: University Rovira i Virgili
This trial is testing a structured mental wellness program called Mentis Plus+ Caregivers, designed specifically for unpaid family caregivers of people with dementia. Researchers want to know whether it reduces depression, anxiety, stress, and caregiver burnout compared to standard primary care support. This is a Phase NA randomized controlled trial, meaning it is evaluating real-world effectiveness of a non-drug program rather than testing a new medication.
You may qualify if
- Informal caregivers of non-institutionalised individuals with dementia
- Aged 18 years or older
- A minimum of four months' experience in the informal caregiving role
You're excluded if
- Unable to read and write in Portuguese
- Currently participating in another intervention study targeting informal caregivers, or participation in such a study within the past 3 months
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-10-20