Efficacy of Positive Mental Health Program for Adults - Study Protocol

Study Overview
=================
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: 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; 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.

Official Title
-----------------
Efficacy of Positive Mental Health Program for Adults

Conditions
-----------------
Mental Health

Intervention / Treatment
-----------------
* Other: Mentis Plus+ (Experimental Group)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allocated to either the Mentis Plus+ program (experimental group) or the control group (stand-by group).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants integrate the Mentis Plus+ program<br>Mentis Plus+ Program was developed based in The Multifactorial Model of Positive Mental Health and its construction resulted from a systematic literature review and validation through focus group. The duration of the Mentis Plus+ program depends on the number of the six factors to be worked on. The Mentis Plus+ lasts at least 7 weeks (1 session per week, lasting 1 hour) and can work individually or in groups (2-12 people). There will be 2 initial sessions of 1 hour each and 3 sessions for each factor to work with duration of 1 hour. Still, a final session and a follow-up session (3-6 months after the program) will be held. | Other: Mentis Plus+ (Experimental Group)<br>* Each factor can be considered a module, so it is a modular program. So, each module has 3 sessions to be carried out in full. It is a systematic program, so the order of the sessions is regulated by the letters A, B and C for each module. The modules to be worked on correspond to the low-level or languising factors identified after the application of the positive mental health questionnaire (PMHQ). After the application of the PMHQ, people are grouped with the same module to work.<br>|
| No Intervention: Participants on a waiting list (Control Group)<br>Participants in the control group were told they were on a waiting list for 3-6 months, as a minimum, before they integrate the Mentis Plus+ program. Given the preventive nature of this study, a waiting list control group won't bring risks or damages to participants | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Mental Health Questionnaire (PMHQ) - moment 1 | The PMHQ consists of 39 items. In the PMHQ, values between 39 (minimum value) and 156 (maximum value) can be obtained, and higher the value obtained, lower the positive Mental Health level is. Therefore, we can categorize different levels of Positive Mental Health: High level or Flourishing (Results between 39-78), Intermediate level (Results between 79-117) and Low level or Languising (Results between 118-156). | PMHQ will be applied in the baseline of the Mentis Plus+ Program, to both groups | 
| Positive Mental Health Questionnaire (PMHQ) - moment 2 | The PMHQ consists of 39 items. In the PMHQ, values between 39 (minimum value) and 156 (maximum value) can be obtained, and higher the value obtained, lower the positive Mental Health level is. Therefore, we can categorize different levels of Positive Mental Health: High level or Flourishing (Results between 39-78), Intermediate level (Results between 79-117) and Low level or Languising (Results between 118-156). | PMHQ will be applied up to 18 weeks of the Mentis Plus + Program,to both groups | 
| Positive Mental Health Questionnaire (PMHQ) - moment 3 | The PMHQ consists of 39 items. In the PMHQ, values between 39 (minimum value) and 156 (maximum value) can be obtained, and higher the value obtained, lower the positive Mental Health level is. Therefore, we can categorize different levels of Positive Mental Health: High level or Flourishing (Results between 39-78), Intermediate level (Results between 79-117) and Low level or Languising (Results between 118-156). | The PMHQ will be reapplied for follow-up of the evaluation, after completion of the study, on average 3 months, in both groups | 
| Psychological Vulnerability Scale (PVS) - moment 1 | The PVS is a six-item scale. Each item is measured in a scale Frequency Likert five points (1-5), where a higher number corresponds to greater frequency (does not describe me at all = 1 to describes me very well = 5). Possible total scores range from 6 to 30, with higher scores indicating greater psychological vulnerability. greater psychological vulnerability. | PVS will be applied in the baseline of the Mentis Plus+ Program, to both groups | 
| Psychological Vulnerability Scale (PVS) - moment 2 | The PVS is a six-item scale. Each item is measured in a scale Frequency Likert five points (1-5), where a higher number corresponds to greater frequency (does not describe me at all = 1 to describes me very well = 5). Possible total scores range from 6 to 30, with higher scores indicating greater psychological vulnerability. greater psychological vulnerability. | PVS will be applied up to 18 weeks of the Mentis Plus + Program,to both groups | 
| Psychological Vulnerability Scale (PVS) - moment 3 | The PVS is a six-item scale. Each item is measured in a scale Frequency Likert five points (1-5), where a higher number corresponds to greater frequency (does not describe me at all = 1 to describes me very well = 5). Possible total scores range from 6 to 30, with higher scores indicating greater psychological vulnerability. greater psychological vulnerability. | PVS will be reapplied for follow-up of the evaluation, after completion of the study, on average 3 months, in both groups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemografic and clinical data - moment 1 | Gender, age, marital status, educational level, professional bond, displacement of usual residence, years of professional practice, hours of work per week, history of mental illness, health behaviors in the last month, consumption of psychoactive substances | Sociodemografic and clinical data will be applied in the baseline of the Mentis Plus+ Program, to both groups | 
| Sociodemografic and clinical data - moment 2 | Gender, age, marital status, educational level, professional bond, displacement of usual residence, years of professional practice, hours of work per week, history of mental illness, health behaviors in the last month, consumption of psychoactive substances | Sociodemografic and clinical data will be applied up to 18 weeks of the Mentis Plus + Program,to both groups | 
| Sociodemografic and clinical data - moment 3 | Gender, age, marital status, educational level, professional bond, displacement of usual residence, years of professional practice, hours of work per week, history of mental illness, health behaviors in the last month, consumption of psychoactive substances | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mental health, program, randomized controlled trial, nursing, health promotion, adult