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

NCT07577440 | Recruiting DMC

• 1 other identifier: CEIPSA-2023-TDO-0004
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health

Keywords

Caregivers; Dementia; Mental Health

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (8)

• Depression anxiety stress scale-21 (DASS-21)

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

• Depression anxiety stress scale-21 (DASS-21)

  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)

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

• Caregiver burden scale (CBS)

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

• Caregiver burden scale (CBS)

  CBS It will be administered 6 weeks after the beginning of the Mentis Plus+ Caregivers programme for both groups.

Study Arms (2)

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 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

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 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.

Interventions

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.

Participants will take part in the Mentis Plus+ Caregivers programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Rovira i Virgili: lead
• Unidade Local de Saúde de Matosinhos, EPE: collaborator

Study Sites (1)

Sofia Garrido

Porto, 4464-513, Portugal

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Dementia

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The researcher, who will collect the outcome assessments and be responsible for data entry and analysis, will remain blinded to the treatment allocations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Participants will be randomly allocated to the Mentis Plus+Caregivers programme (experimental group) or to the control group (waitlist group).

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 11, 2026
• Study Start: May 3, 2026
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): September 24, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

PT (1)