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NCT Number: NCT07577440

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sofia Garrido

Porto, 4464-513, Portugal

Location status: Recruiting

Location contact

Graça Farelo Manager in the Mental Health Department, Master

CONTACT

[email protected]

+351229391441

Sofia Canedo Garrido, Master

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mentis Plus+ Caregivers

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Positive Mental Health Questionnaire (PMHQ)

    Time frame: 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.

Secondary outcomes

  1. 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.

    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

  2. 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.

    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

  3. 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.

    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

  4. Caregiver burden scale (CBS)

    Time frame: CBS It will be administered at baseline of the Mentis Plus+ 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)

  5. 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.

    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)

  6. Caregiver burden scale (CBS)

    Time frame: 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)

  7. 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.

    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

  8. 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.

    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.

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Collaborators

  • Unidade Local de Saúde de Matosinhos, EPE

Registry information

Official study title

Effectiveness of a Positive Mental Health Promotion Programme for Adult Informal Caregivers of People With Dementia: A Randomised Controlled Trial Protocol

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 11, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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