Efficacy of Positive Mental Health Program for Adults - Study Protocol

Not Applicable

• Conditions: Mental Health
• Interventions: Other: Mentis Plus+ (Experimental Group)

• Registration Number: NCT04600401
• Lead Sponsor: Carme Ferré Grau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2020-05-15
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-18
• Last Update Submitted: 2020-10-18
• Study First Posted: 2020-10-23
• Last Update Posted: 2020-10-23
• Primary Completion: 2021-08-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants integrate the Mentis Plus+ program	Mentis Plus+ (Experimental Group)	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.

Primary Outcome Measures

Name	Time	Method
Positive Mental Health Questionnaire (PMHQ) - moment 1	PMHQ will be applied in the baseline of the Mentis Plus+ Program, to both groups	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).
Psychological Vulnerability Scale (PVS) - moment 1	PVS will be applied in the baseline of the Mentis Plus+ Program, to both groups	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.
Psychological Vulnerability Scale (PVS) - moment 3	PVS will be reapplied for follow-up of the evaluation, after completion of the study, on average 3 months, in both groups	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.
Positive Mental Health Questionnaire (PMHQ) - moment 2	PMHQ will be applied up to 18 weeks of the Mentis Plus + Program,to both groups	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).
Positive Mental Health Questionnaire (PMHQ) - moment 3	The PMHQ will be reapplied for follow-up of the evaluation, after completion of the study, on average 3 months, in both groups	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).
Psychological Vulnerability Scale (PVS) - moment 2	PVS will be applied up to 18 weeks of the Mentis Plus + Program,to both groups	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.

Secondary Outcome Measures

Name	Time	Method
Sociodemografic and clinical data - moment 1	Sociodemografic and clinical data will be applied in the baseline of the Mentis Plus+ Program, to both groups	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 - moment 3	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	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 - moment 2	Sociodemografic and clinical data will be applied up to 18 weeks of the Mentis Plus + Program,to both groups	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

Trial Locations

Locations (1)

ACES Cavado I; 🇵🇹 Braga, Portugal