NCT07577440RecruitingNot Applicable
Effectiveness of a Positive Mental Health Promotion Programme for Adult Informal Caregivers of People With Dementia: A Randomised Controlled Trial Protocol
University Rovira i Virgili1 site in 1 country108 target enrollmentStarted: May 3, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 108
- Locations
- 1
Study Overview
Brief Summary
The primary objective of this study is to evaluate the effectiveness of the Mentis Plus+ Positive Mental Health Promotion Programme for caregivers (Mentis Plus+ Caregivers), compared with usual primary health care, in improving positive mental health among adult informal caregivers of people with dementia. The secondary objectives are to assess the programme's effectiveness in reducing symptoms of depression, anxiety and stress, as well as caregiver burden, compared with usual care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Masking Description
The researcher, who will collect the outcome assessments and be responsible for data entry and analysis, will remain blinded to the treatment allocations.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informal caregivers of non-institutionalised individuals with dementia
- •Aged 18 years or older
- •A minimum of four months' experience in the informal caregiving role
- •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
- •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
Investigators
Sofia Canedo Garrido
PhD student
University Rovira i Virgili
Study Sites (1)
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