Menu
Recruiting NCT07577440

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

No phase Interventional Mental Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mentis Plus+ Caregivers.
Who it may be relevant to
Registry conditions: Mental Health. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 Questio

Primary outcome measures

  • Positive Mental Health Questionnaire (PMHQ) [Time frame: PMHQ It will be administered at baseline of the Mentis Plus+ Caregivers programme for both groups.]
  • 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.]
  • 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.]
Secondary outcome measures (8)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Portugal · 1 center
  • Sofia Garrido — Porto

Identifiers

NCT: NCT07577440 · CEIPSA-2023-TDO-0004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗