Mental HealthNCT04600401

Efficacy of Positive Mental Health Program for Adults - Study Protocol

A study testing Mentis Plus+ (Experimental Group) in people with Mental Health, run by Carme Ferré Grau at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Mental Health
What is being tested?: Mentis Plus+ (Experimental Group)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 sitePortugal
Study dates: 15 May 2020to 31 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

non-Portuguese speakers

Trial locations and contacts

1 site in 1 country.

Portugal1 site, 1 recruiting

ACES Cavado I
Braga, 4700
Sónia Teixeira, Master, 919600975, sonia_lixa@hotmail.com
Paula Machado, Nurse, 925062991, pmachado@arsnorte.min-saude.pt
Recruiting

Other trials in Portugal

About this study

Official title: 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:

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;
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
Being tested: Mentis Plus+ (Experimental Group)
Keywords: mental health, program, randomized controlled trial, nursing, health promotion, adult
Medical subject headings: Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT04600401
Study group	Role	What they receive
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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 202031 Dec 2021

First posted23 Oct 2020
Study start15 May 2020
Primary completion31 Aug 2021 (estimated)
Study completion31 Dec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mental HealthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomly allocated to either the Mentis Plus+ program (experimental group) or the control group (stand-by group).
Masking: Single blind
Who is masked: Investigator
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04600401
Sponsor's protocol ID: 2020PMHP.PT
Status last verified: Oct 2020
First submitted: 15 May 2020
Last updated: 23 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39359154

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Positive Mental Health Program for Adults
ClinicalTrials.gov ID: NCT04600401
Acronym / sponsor ID: 2020PMHP.PT
Conditions: Mental Health
Keywords: mental health, program, randomized controlled trial, nursing, health promotion, adult
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Carme Ferré GrauUniversity, hospital or other
Collaborators: Administração Regional de Saúde do Norte, Portugal
Study start: 15 May 2020 (actual)
Primary completion: 31 Aug 2021 (estimated)
Study completion: 31 Dec 2021 (estimated)
First posted: 23 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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;
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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: Participants will be randomly allocated to either the Mentis Plus+ program (experimental group) or the control group (stand-by group).

Arm	Type	Receives
Participants integrate the Mentis Plus+ program	Experimental	Other: 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.
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

non-Portuguese speakers

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Other	Participants integrate the Mentis Plus+ program

Primary outcome

Positive Mental Health Questionnaire (PMHQ) - moment 1
Time frame: 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).
Positive Mental Health Questionnaire (PMHQ) - moment 2
Time frame: 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
Time frame: 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 1
Time frame: 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 2
Time frame: 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.
Psychological Vulnerability Scale (PVS) - moment 3
Time frame: 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.

3 secondary outcomes

Sociodemografic and clinical data - moment 1
Time frame: Sociodemografic and clinical data will be applied in the baseline of the Mentis Plus+ Program, to both groups
Sociodemografic and clinical data - moment 2
Time frame: 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
Time frame: 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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
Derived from this study: PubMed 39359154Teixeira 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ACES Cavado I

Braga, Portugal

919600975

sonia_lixa@hotmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mentis Plus+ (Experimental Group) in people with Mental Health, run by Carme Ferré Grau at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Mental Health Questionnaire (PMHQ) - moment 1 (time frame: PMHQ will be applied in the baseline of the Mentis Plus+ Program, to both groups). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04600401, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.