Effectiveness of a Positive Mental Health Promotion Programme for Informal Caregivers of People With Dementia
8 mei 2026 bijgewerkt door: Sofia Canedo Garrido, University Rovira i Virgili
Effectiveness of a Positive Mental Health Promotion Programme for Adult Informal Caregivers of People With Dementia: A Randomised Controlled Trial Protocol
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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
108
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Porto, Portugal, 4464-513
- Werving
- Sofia Garrido
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Contact:
- Graça Farelo Manager in the Mental Health Department, Master
- Telefoonnummer: +351229391441
- E-mail: graca.farelo@ulsm.min-saude.pt
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Hoofdonderzoeker:
- Sofia Canedo Garrido, Master
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Participants will take part in the Mentis Plus+ Caregivers programme
The Mentis Plus+ Caregivers programme is an adaptation of the Mentis Plus+ intervention for informal caregivers of people with dementia. The original Mentis Plus+ programme was developed based on the Multifactorial Model of Positive Mental Health. The intervention will last 7 weeks (one session per week, each lasting approximately 1 hour) and may be delivered individually or in groups of 2 to 12 participants. It will consist of two initial sessions, followed by three sessions focused on the selected factor. In addition, a final session and a follow-up session (3 to 6 months after programme completion) will be conducted. |
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.
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Geen tussenkomst: Participants on a waiting list (control group)
Participants allocated to the control group will be informed that they will remain on a waiting list for a minimum of 3 to 6 months before receiving the Mentis Plus+ programme.
Given the preventive nature of this study, the use of a waiting list control group is not expected to pose any risks or harm to participants.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Positive Mental Health Questionnaire (PMHQ)
Tijdsspanne: PMHQ It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups.
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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.
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PMHQ It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups.
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Positive Mental Health Questionnaire (PMHQ)
Tijdsspanne: PMHQ will be administered 6 weeks after the beginning of the Mentis Plus+ Caregivers programme for both groups.
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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.
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PMHQ will be administered 6 weeks after the beginning of the Mentis Plus+ Caregivers programme for both groups.
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Positive Mental Health Questionnaire (PMHQ)
Tijdsspanne: The PMHQ will be re-administered for follow-up assessment approximately 3 months after study completion in 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.
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The PMHQ will be re-administered for follow-up assessment approximately 3 months after study completion in both groups.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Depression anxiety stress scale-21 (DASS-21)
Tijdsspanne: DASS-21 It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups.
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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
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DASS-21 It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups.
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Depression anxiety stress scale-21 (DASS-21)
Tijdsspanne: DASS-21 It will be administered 6 weeks after the beginning 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
|
DASS-21 It will be administered 6 weeks after the beginning of the Mentis Plus+ Caregivers programme for both groups.
|
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Depression anxiety stress scale-21 (DASS-21)
Tijdsspanne: DASS-21 It will be re-administered for follow-up assessment approximately 3 months after study completion in 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
|
DASS-21 It will be re-administered for follow-up assessment approximately 3 months after study completion in both groups.
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Caregiver burden scale (CBS)
Tijdsspanne: CBS It will be administered at baseline of the Mentis Plus+ programme for both groups.
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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)
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CBS It will be administered at baseline of the Mentis Plus+ programme for both groups.
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Caregiver burden scale (CBS)
Tijdsspanne: CBS It will be administered 6 weeks after the beginning of the Mentis Plus+ Caregivers 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)
|
CBS It will be administered 6 weeks after the beginning of the Mentis Plus+ Caregivers programme for both groups.
|
|
Caregiver burden scale (CBS)
Tijdsspanne: CBS will be re-administered for follow-up assessment approximately 3 months after study completion in 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)
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CBS will be re-administered for follow-up assessment approximately 3 months after study completion in both groups.
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Sociodemographic and caregiving characteristics questionnaire
Tijdsspanne: Sociodemographic and caregiving characteristics questionnaire will be collected at baseline of the Mentis Plus+Caregivers programme for both groups.
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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
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Sociodemographic and caregiving characteristics questionnaire will be collected at baseline of the Mentis Plus+Caregivers programme for both groups.
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Ad hoc Mentis Plus+ Caregivers Programme satisfaction questionnaire
Tijdsspanne: 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.
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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.
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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.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
3 mei 2026
Primaire voltooiing (Geschat)
2 mei 2027
Studie voltooiing (Geschat)
24 september 2027
Studieregistratiedata
Eerst ingediend
3 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
3 mei 2026
Eerst geplaatst (Werkelijk)
11 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
8 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CEIPSA-2023-TDO-0004
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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