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

ConditionMental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Rovira i Virgili

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informal caregivers of non-institutionalised individuals with dementia

Aged 18 years or older

A minimum of four months' experience in the informal caregiving role

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Mentis Plus+ Caregivers

    Other intervention

    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.

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Participants will take part in the Mentis Plus+ Caregivers programmeExperimental treatment 1 intervention
Group B: Participants on a waiting list (control group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
PMHQ It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups.
2

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.

Time frame
PMHQ will be administered 6 weeks after the beginning of the Mentis Plus+ Caregivers programme for both groups.
3

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.

Time frame
The PMHQ will be re-administered for follow-up assessment 3 months after study completion in both groups.

Secondary outcomes

1

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

Time frame
DASS-21 It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups.
2

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

Time frame
DASS-21 It will be administered 6 weeks after the beginning of the Mentis Plus+ Caregivers programme for both groups.
3

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

Time frame
DASS-21 It will be re-administered for follow-up assessment approximately 3 months after study completion in both groups.
4

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)

Time frame
CBS It will be administered at baseline of the Mentis Plus+ programme for both groups.

Other outcomes

Sponsors and contacts

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University Rovira i Virgili

Lead sponsor

Unidade Local de Saúde de Matosinhos, EPE

Collaborator