Mental HealthNCT07577440
Effectiveness of the Self-Control Module of a Positive Mental Health Promotion Programme for Adult Informal Caregivers of People With Dementia: Protocol for a Randomised Controlled Trial
A study testing Mentis Plus+ Caregivers in people with Mental Health, run by University Rovira i Virgili at 1 site in Portugal.
Trial summary
The primary objective of this study is to evaluate the effectiveness of the self-control module of the Mentis Plus+ Positive Mental Health Promotion Programme for Caregivers (Mentis Plus+ Caregivers), compared with usual care, in improving positive mental health among adult informal caregivers of people with dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Mentis Plus+ Caregivers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePortugal
- Study dates
- 3 May 2026to 24 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informal caregivers of non-institutionalised individuals with dementia
- Aged 18 years or older
- A minimum of four months' experience in the informal caregiving role
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Self-Control Module 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 self-control module of the Mentis Plus+ Positive Mental Health Promotion Programme for Caregivers (Mentis Plus+ Caregivers), compared with usual 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 caregiver burden, compared with usual care.
- Conditions
- Mental Health
- Being tested
- Mentis Plus+ Caregivers
- Keywords
- Caregivers, Dementia, Mental Health
- Medical subject headings
- Psychological Well-Being, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentis Plus+ CaregiversOther
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 Self-control module (F3) was selected due to its particular relevance for informal caregivers of people with dementia, given the emotional and behavioural demands inherent in caregiving. 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 3 months after programme completion.
| Study group | Role | What they receive |
|---|---|---|
| Participants will take part in the Mentis Plus+ Caregivers programme | Experimental | 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 factor self-control (F3). In addition, a final session and a follow-up session 3 months after programme completion will be conducted. Receives: Other: Mentis Plus+ Caregivers |
| Participants on a waiting list (control group) | No intervention | Participants allocated to the control group will be informed that they will remain on a waiting list for a minimum of 3 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: The PMHQ will be re-administered for follow-up assessment 3 months after study completion in both groups.
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start3 May 2026
- Primary completion2 May 2027 (estimated)
- Study completion24 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to the Mentis Plus+Caregivers programme (experimental group) or to the control group (waitlist group).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde de Matosinhos, EPE
- Responsible party
- Principal investigator, Sofia Canedo Garrido, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577440
- Sponsor's protocol ID
- CEIPSA-2023-TDO-0004
- Status last verified
- Oct 2026
- First submitted
- 3 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Self-Control Module of a Positive Mental Health Promotion Programme for Adult Informal Caregivers of People With Dementia: A Randomised Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT07577440
- Acronym / sponsor ID
- CEIPSA-2023-TDO-0004
- Conditions
- Mental Health
- Keywords
- Caregivers, Dementia, Mental Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde de Matosinhos, EPE
- Study start
- 3 May 2026 (actual)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 24 Sep 2027 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the effectiveness of the self-control module of the Mentis Plus+ Positive Mental Health Promotion Programme for Caregivers (Mentis Plus+ Caregivers), compared with usual 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 caregiver burden, compared with usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to the Mentis Plus+Caregivers programme (experimental group) or to the control group (waitlist group).
| Arm | Type | Receives |
|---|---|---|
| Participants will take part in the Mentis Plus+ Caregivers programme | Experimental | Other: Mentis Plus+ CaregiversThe 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 factor self-control (F3). In addition, a final session and a follow-up session 3 months after programme completion will be conducted. |
| Participants on a waiting list (control group) | No intervention | –Participants allocated to the control group will be informed that they will remain on a waiting list for a minimum of 3 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informal caregivers of non-institutionalised individuals with dementia
- Aged 18 years or older
- A minimum of four months' experience in the informal caregiving role
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentis Plus+ CaregiversMentis 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 Self-control module (F3) was selected due to its particular relevance for informal caregivers of people with dementia, given the emotional and behavioural demands inherent in caregiving. 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 3 months after programme completion. | Other | Participants will take part in the Mentis Plus+ Caregivers programme |
Primary outcome
Positive Mental Health Questionnaire (PMHQ)
Time frame: 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.
Positive Mental Health Questionnaire (PMHQ)
Time frame: 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.
Positive Mental Health Questionnaire (PMHQ)
Time frame: The PMHQ will be re-administered for follow-up assessment 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.
8 secondary outcomes
Depression anxiety stress scale-21 (DASS-21)
Time frame: DASS-21 It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups.
Depression anxiety stress scale-21 (DASS-21)
Time frame: 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)
Time frame: DASS-21 It will be re-administered for follow-up assessment approximately 3 months after study completion in both groups.
Caregiver burden scale (CBS)
Time frame: CBS It will be administered at baseline of the Mentis Plus+ programme for both groups.
Caregiver burden scale (CBS)
Time frame: CBS It will be administered 6 weeks after the beginning of the Mentis Plus+ Caregivers programme for both groups.
Caregiver burden scale (CBS)
Time frame: CBS will be re-administered for follow-up assessment approximately 3 months after study completion in both groups.
Sociodemographic and caregiving characteristics questionnaire
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentis Plus+ Caregivers in people with Mental Health, run by University Rovira i Virgili at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Mental Health Questionnaire (PMHQ) (time frame: PMHQ It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.