Efficacy of Positive Mental Health Program for Adults - Study Protocol

Efficacy of Positive Mental Health Program for Adults

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.

Study Overview

• Status: Unknown
• Conditions: Mental Health
• Intervention / Treatment: Other: Mentis Plus+ (Experimental Group)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Braga, Portugal, 4700
    • Recruiting
    • ACES Cavado I
    • Contact: Sónia Teixeira, Master; Phone Number: 919600975; Email: sonia_lixa@hotmail.com
    • Contact: Paula Machado, Nurse; Phone Number: 925062991; Email: pmachado@arsnorte.min-saude.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants integrate the Mentis Plus+ program; 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); 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.
No Intervention: Participants on a waiting list (Control Group); 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

Collaborators and Investigators

• Sponsor: Carme Ferré Grau
• Collaborators: Administração Regional de Saúde do Norte, Portugal

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: October 18, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 18, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: adult; randomized controlled trial; mental health; program; nursing; health promotion
• Other Study ID Numbers: 2020PMHP.PT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No