Effectiveness of a Positive Mental Health Promotion Programme for Informal Caregivers of People With Dementia
2026年5月8日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
108
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Porto、葡萄牙、4464-513
- 招聘中
- Sofia Garrido
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接触：
- Graça Farelo Manager in the Mental Health Department, Master
- 电话号码：+351229391441
- 邮箱：graca.farelo@ulsm.min-saude.pt
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首席研究员：
- Sofia Canedo Garrido, Master
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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无干预：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Positive Mental Health Questionnaire (PMHQ)
大体时间：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)
大体时间：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)
大体时间：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.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Depression anxiety stress scale-21 (DASS-21)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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.
|
|
Caregiver burden scale (CBS)
大体时间：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)
大体时间：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)
|
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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月3日
初级完成 (估计的)
2027年5月2日
研究完成 (估计的)
2027年9月24日
研究注册日期
首次提交
2026年5月3日
首先提交符合 QC 标准的
2026年5月3日
首次发布 (实际的)
2026年5月11日
研究记录更新
最后更新发布 (实际的)
2026年5月13日
上次提交的符合 QC 标准的更新
2026年5月8日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.