Clinical trial NCT04600401: Efficacy of Positive Mental Health Program for Adults - Study Protocol
Official title: Efficacy of Positive Mental Health Program for Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health
Keywords: mental health
program
randomized controlled trial
nursing
health promotion
adult
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: Administração Regional de Saúde do Norte, Portugal
First posted: 2020-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to either the Mentis Plus+ program (experimental group) or the control group (stand-by group).
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the efficacy of a positive mental health program for adults, designated Mentis Plus+, in community. Our hypotheses are:

1. compared with the wait-list control group, the persons who join the experimental group and participate in the Mentis Plus+, will have more positive mental health on the end of the program;
2. in the Mentis Plus+ participants, positive mental health will be increased at the end of the program and at follow-up (three- six months later) and their psychological vulnerability will reduce.


Eligibility criteria: Inclusion Criteria:

* to be a participant aged ≥ 18;
* participant without a diagnosis of psychiatric pathology;
* agree to participate in the program by signing informed consent;
* participant with the "low-level or languising" in at least one factor of the positive mental health questionnaire

Exclusion Criteria:

* non-Portuguese speakers

Primary outcomes:
measure: Positive Mental Health Questionnaire (PMHQ) - moment 1
timeFrame: PMHQ will be applied in the baseline of the Mentis Plus+ Program, to both groups
measure: Positive Mental Health Questionnaire (PMHQ) - moment 2
timeFrame: PMHQ will be applied up to 18 weeks of the Mentis Plus + Program,to both groups
measure: Positive Mental Health Questionnaire (PMHQ) - moment 3
timeFrame: The PMHQ will be reapplied for follow-up of the evaluation, after completion of the study, on average 3 months, in both groups
measure: Psychological Vulnerability Scale (PVS) - moment 1
timeFrame: PVS will be applied in the baseline of the Mentis Plus+ Program, to both groups
measure: Psychological Vulnerability Scale (PVS) - moment 2
timeFrame: PVS will be applied up to 18 weeks of the Mentis Plus + Program,to both groups
measure: Psychological Vulnerability Scale (PVS) - moment 3
timeFrame: PVS will be reapplied for follow-up of the evaluation, after completion of the study, on average 3 months, in both groups
Secondary outcomes:
measure: Sociodemografic and clinical data - moment 1
timeFrame: Sociodemografic and clinical data will be applied in the baseline of the Mentis Plus+ Program, to both groups
measure: Sociodemografic and clinical data - moment 2
timeFrame: Sociodemografic and clinical data will be applied up to 18 weeks of the Mentis Plus + Program,to both groups
measure: Sociodemografic and clinical data - moment 3
timeFrame: Sociodemografic and clinical data will be reapplied for follow-up of the evaluation, after completion of the study, on average 3 months, in both groups
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: ACES Cavado I
Study officials:
References: