Effectiveness of a Positive Mental Health Promotion Programme for Informal Caregivers of People With Dementia
8 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Tipo de estudo
Intervencional
Inscrição (Estimado)
108
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Porto, Portugal, 4464-513
- Recrutamento
- Sofia Garrido
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Contato:
- Graça Farelo Manager in the Mental Health Department, Master
- Número de telefone: +351229391441
- E-mail: graca.farelo@ulsm.min-saude.pt
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Investigador principal:
- Sofia Canedo Garrido, Master
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Positive Mental Health Questionnaire (PMHQ)
Prazo: 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.
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PMHQ It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups.
|
|
Positive Mental Health Questionnaire (PMHQ)
Prazo: PMHQ will be administered 6 weeks after the beginning 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.
|
PMHQ will be administered 6 weeks after the beginning of the Mentis Plus+ Caregivers programme for both groups.
|
|
Positive Mental Health Questionnaire (PMHQ)
Prazo: 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.
|
The PMHQ will be re-administered for follow-up assessment approximately 3 months after study completion in both groups.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Depression anxiety stress scale-21 (DASS-21)
Prazo: 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
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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)
Prazo: 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.
|
|
Depression anxiety stress scale-21 (DASS-21)
Prazo: 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.
|
|
Caregiver burden scale (CBS)
Prazo: 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)
|
CBS It will be administered at baseline of the Mentis Plus+ programme for both groups.
|
|
Caregiver burden scale (CBS)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
3 de maio de 2026
Conclusão Primária (Estimado)
2 de maio de 2027
Conclusão do estudo (Estimado)
24 de setembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
3 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de maio de 2026
Primeira postagem (Real)
11 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CEIPSA-2023-TDO-0004
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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