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.
調査の概要
研究の種類
介入
入学 (推定)
108
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Porto、ポルトガル、4464-513
- 募集
- Sofia Garrido
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コンタクト：
- Graça Farelo Manager in the Mental Health Department, Master
- 電話番号：+351229391441
- メール：graca.farelo@ulsm.min-saude.pt
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主任研究者：
- Sofia Canedo Garrido, Master
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Positive Mental Health Questionnaire (PMHQ)
時間枠：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.
|
|
Positive Mental Health Questionnaire (PMHQ)
時間枠：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.
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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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Depression anxiety stress scale-21 (DASS-21)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月3日
一次修了 (推定)
2027年5月2日
研究の完了 (推定)
2027年9月24日
試験登録日
最初に提出
2026年5月3日
QC基準を満たした最初の提出物
2026年5月3日
最初の投稿 (実際)
2026年5月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月13日
QC基準を満たした最後の更新が送信されました
2026年5月8日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。