Positive mental health program for informal caregivers of people with dementia
Effectiveness of a Positive Mental Health Promotion Programme for Adult Informal Caregivers of People With Dementia: A Randomised Controlled Trial Protocol
This program will try the Mentis Plus+ approach to see if it improves positive mental health for adult informal caregivers of people with dementia compared with usual primary care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Rovira i Virgili Academic / other |
| Locations | 1 site (Porto) |
| Trial ID | NCT07577440 on ClinicalTrials.gov |
What this trial studies
This is an interventional comparison of the Mentis Plus+ Positive Mental Health Promotion Programme versus usual primary health care for adult informal caregivers of people with dementia. The primary outcome is improvement in positive mental health, using the Positive Mental Health Questionnaire to identify caregivers with low or intermediate scores in at least one dimension. Secondary outcomes include changes in symptoms of depression, anxiety, stress, and caregiver burden. Eligible participants are Portuguese-literate informal caregivers aged 18 or older with at least four months' caregiving experience and not currently enrolled in another caregiver intervention.
Who should consider this trial
Good fit: Adult informal caregivers of non-institutionalized people with dementia who have at least four months' caregiving experience and show low or intermediate scores on at least one dimension of the Positive Mental Health Questionnaire.
Not a fit: Caregivers who already have high positive mental health at baseline, cannot read or write Portuguese, or are currently participating in another caregiver intervention are unlikely to benefit from this programme.
Why it matters
Potential benefit: If successful, caregivers could experience improved positive mental health and reductions in depression, anxiety, stress, and caregiver burden.
How similar studies have performed: Other caregiver-focused mental health and support programs (for example psychoeducation or support groups) have shown benefits for depression and burden, but dedicated positive mental health promotion programmes have been less widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Porto
- Sofia Garrido — Porto, Portugal (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.