Effectiveness of a Positive Mental Health Promotion Programme for Informal Caregivers of People With Dementia
2026년 5월 8일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
108
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Porto, 포르투갈, 4464-513
- 모병
- Sofia Garrido
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연락하다:
- Graça Farelo Manager in the Mental Health Department, Master
- 전화번호: +351229391441
- 이메일: graca.farelo@ulsm.min-saude.pt
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수석 연구원:
- Sofia Canedo Garrido, Master
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Positive Mental Health Questionnaire (PMHQ)
기간: 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.
|
PMHQ It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups.
|
|
Positive Mental Health Questionnaire (PMHQ)
기간: 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)
기간: 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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depression anxiety stress scale-21 (DASS-21)
기간: 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
|
DASS-21 It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups.
|
|
Depression anxiety stress scale-21 (DASS-21)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 5월 3일
기본 완료 (추정된)
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2027년 5월 2일
연구 완료 (추정된)
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2027년 9월 24일
연구 등록 날짜
최초 제출
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2026년 5월 3일
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2026년 5월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
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2026년 5월 1일
추가 정보
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기타 연구 ID 번호
기타 연구 ID 번호
- CEIPSA-2023-TDO-0004
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