Efficacy of Positive Mental Health Program for Adults - Study Protocol

NCT04600401 | Unknown

• 1 other identifier: 2020PMHP.PT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Mental Health

Keywords

mental health; program; randomized controlled trial; nursing; health promotion; adult

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Sociodemografic and clinical data - moment 1

  Sociodemografic and clinical data will be applied in the baseline of the Mentis Plus+ Program, to both groups

• 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

• 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

Study Arms (2)

Participants integrate the Mentis Plus+ program

EXPERIMENTAL

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)

Participants on a waiting list (Control Group)

NO INTERVENTION

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

Interventions

Mentis Plus+ (Experimental Group) OTHER

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.

Participants integrate the Mentis Plus+ program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• non-Portuguese speakers

Sponsors & Collaborators

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

Study Sites (1)

ACES Cavado I

Braga, 4700, Portugal

RECRUITING

Related Publications (1)

• Teixeira SMA, Ferre-Grau C, da Cruz Sequeira CA, Santos JM, Guerra MM, Lluch MT. Randomized Controlled Trial to Evaluate the Efficacy of Positive Mental Health Program for Adults: Study Protocol. Public Health Nurs. 2025 Jan-Feb;42(1):154-160. doi: 10.1111/phn.13427. Epub 2024 Oct 3.

  PMID: 39359154 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: the researcher, who will collect the outcome assessments and assume data entry and analysis, will stay blinded to treatment allocations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Participants will be randomly allocated to either the Mentis Plus+ program (experimental group) or the control group (stand-by group).

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: October 23, 2020
• Study Start: May 15, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)