Effectiveness of a Positive Mental Health Promotion Programme for Informal Caregivers of People With Dementia

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Health
• Intervention / Treatment: Other: Mentis Plus+ Caregivers

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4464-513
    • Recruiting
    • Sofia Garrido
    • Contact: Graça Farelo Manager in the Mental Health Department, Master; Phone Number: +351229391441; Email: graca.farelo@ulsm.min-saude.pt
    • Principal Investigator: Sofia Canedo Garrido, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Mentis Plus+ Caregivers; 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Mental Health Questionnaire (PMHQ)	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)	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)	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression anxiety stress scale-21 (DASS-21)	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)	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)	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)	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)	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)	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.
Sociodemographic and caregiving characteristics questionnaire	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	Sociodemographic and caregiving characteristics questionnaire will be collected at baseline of the Mentis Plus+Caregivers programme for both groups.
Ad hoc Mentis Plus+ Caregivers Programme satisfaction questionnaire	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.	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.

Collaborators and Investigators

• Sponsor: University Rovira i Virgili
• Collaborators: Unidade Local de Saúde de Matosinhos, EPE

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2026
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): September 24, 2027

Study Registration Dates

• First Submitted: May 3, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; Dementia; Caregivers
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Behavior; Personal Satisfaction; Dementia; Psychological Well-Being
• Other Study ID Numbers: CEIPSA-2023-TDO-0004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No