Efficacy of Positive Mental Health Program for Adults - Study Protocol

Mental Health Clinical Trial

Official title:

Efficacy of Positive Mental Health Program for Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04600401
• Other study ID #: 2020PMHP.PT
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health

Intervention

Other:
• Mentis Plus+ (Experimental Group)
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.

Locations

Country	Name	City	State
Portugal	ACES Cavado I	Braga

Sponsors (2)

Lead Sponsor	Collaborator
Carme Ferré Grau	Administração Regional de Saúde do Norte, Portugal

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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