NCT07577440 · RECRUITING
Effectiveness of a Positive Mental Health Promotion Programme for Informal Caregivers of People With Dementia: A Randomised Controlled Trial Protocol
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.
Eligibility criteria
Inclusion Criteria: (i) informal caregivers of individuals with a clinical diagnosis of dementia; (ii) aged 18 years or older; (iii) a minimum of four months' experience in the informal caregiving role; and (iv) vulnerability in positive mental health, defined as a low or intermediate level in at least one dimension of the Positive Mental Health Questionnaire Exclusion Criteria: (i) do not have sufficient proficiency in the Portuguese language to ensure adequate comprehension and communication; or (ii)are currently participating in another intervention study targeting informal caregivers or have participated 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 2026-05-11