Mental Health
Conditions
Keywords
Caregivers, Dementia, Mental Health
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.
Interventions
OTHERMentis Plus+ Caregivers
Mentis Plus+Caregivers is a positive mental health promotion programme for informal caregivers of people with dementia. It is organised into six modules: (F1) Personal Satisfaction; (F2) Prosocial Attitude; (F3) Self-control; (F4) Autonomy; (F5) Problem-solving and Self-actualisation; and (F6) Interpersonal Relationship Skills. Each module is delivered through three sequential sessions (A, B and C). The identification of target module is based on the results of the Positive Mental Health Questionnaire "low-scoring or declining" . In addition to the modular sessions, the programme includes two initial sessions, an introductory session (group or individual) and a first individual session, and two final sessions, consisting of a final assessment session and an individual follow-up session conducted between 3 and 6 months after programme completion. Participants are grouped according to the same module to be addressed.
Sponsors
University Rovira i Virgili
Unidade Local de Saúde de Matosinhos, EPE
Study design
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.
Intervention model description
Participants will be randomly allocated to the Mentis Plus+Caregivers programme (experimental group) or to the control group (waitlist group).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Mental Health Questionnaire (PMHQ) | PMHQ It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups. | This instrument consists of 39 items that assess thoughts, feelings, and behaviours, grounded in the multifactorial model of Positive Mental Health and its six key factors. The participants were invited to select the frequency option they most identified with, presented on a 4-point Likert scale (1 to 4): "always or almost always" (1), "most of the time" (2), "sometimes" (3), and "rarely or never" (4). This instrument makes it possible to calculate the level of positive mental health for each factor, allowing the identification of which factor, or factors, requires intervention. The score ranges from 39 to 156, with the possibility of categorizing into different levels depending on the results, namely low or languishing (39 to 78), intermediate (79 to 117), high or flourishing (118 to 156), with a higher score representing higher level of Positive Mental Health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression anxiety stress scale-21 (DASS-21) | DASS-21 It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups. | The Depression Anxiety Stress Scale with 21 items (DASS-21) is the short version of the original DASS, which is composed of 42 items. This self-reported tool represents a three-part model that assesses emotional states with three subscales: depression, anxiety, and stress. The participants are invited to assess each statement with a 4-point Likert scale (0 to 3), from (0) = "nothing applied to me" to (3) = "applied to me most of the time", indicating the extent to which they experienced each symptom in the last week. The scale provides three scores, one per subscale, ranging from 0 to a maximum of 21. Higher scores represent more negative affective states |
| Caregiver burden scale (CBS) | CBS It will be administered at baseline of the Mentis Plus+ programme for both groups. | This self-report instrument measures objective and subjective burden, providing useful information on the impact of caregiving in areas such as health, social and personal life, financial condition, emotional well-being, perception of self-efficacy, and interpersonal relationships, as reported by caregivers. Each item is scored from (1) = "never" to a maximum of (5) = "nearly always". This scale presents a score range from 22 to 110, where a higher score corresponds to a greater perceived burden, with the following cut-off points: no burden (22-46 points), mild burden (47-55 points), and severe burden (56-110 points) |
| Sociodemographic and caregiving characteristics questionnaire | Sociodemographic and caregiving characteristics questionnaire will be collected at baseline of the Mentis Plus+Caregivers programme for both groups. | Participant characteristics: age, sex, education, marital status, employment status, relationship to care recipient, years as a caregiver, daily hours of care, cohabitation/distance, sole caregiver status, caregiver training, area of residence, available support, and free time |
| Ad hoc Mentis Plus+ Caregivers Programme satisfaction questionnaire | The ad hoc Mentis Plus+ Caregivers Programme satisfaction questionnaire will be administered 6 weeks after the beginning of the Mentis Plus+ Caregivers programme for both groups. | This questionnaire was developed by the research team to assess caregivers' satisfaction with the programme, including perceived usefulness, applicability in daily life, adequacy of the sessions, clarity of the materials, session format, and facilitator performance. |
Countries
Portugal
Outcome results
None listed