Efficacy of Positive Mental Health Program for Adults - Study Protocol

Sponsor
Carme Ferré Grau (Other)
Overall Status
Recruiting
CT.gov ID
NCT04600401
Collaborator
Administração Regional de Saúde do Norte, Portugal (Other)
60
1
2
19.5
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mentis Plus+ (Experimental Group)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly allocated to either the Mentis Plus+ program (experimental group) or the control group (stand-by group).Participants will be randomly allocated to either the Mentis Plus+ program (experimental group) or the control group (stand-by group).
Masking:
Single (Investigator)
Masking Description:
the researcher, who will collect the outcome assessments and assume data entry and analysis, will stay blinded to treatment allocations.
Primary Purpose:
Prevention
Official Title:
Efficacy of Positive Mental Health Program for Adults
Actual Study Start Date :
May 15, 2020
Anticipated Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

Secondary Outcome Measures

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ACES Cavado I Braga Portugal 4700

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carme Ferré Grau, Clinical Professor, University Rovira i Virgili
ClinicalTrials.gov Identifier:
NCT04600401
Other Study ID Numbers:
  • 2020PMHP.PT
First Posted:
Oct 23, 2020
Last Update Posted:
Oct 23, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Carme Ferré Grau, Clinical Professor, University Rovira i Virgili

Study Results

No Results Posted as of Oct 23, 2020