Efficacy of Positive Mental Health Program for Adults - Study Protocol

NCT ID: NCT04600401

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly allocated to either the Mentis Plus+ program (experimental group) or the control group (stand-by group).
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
the researcher, who will collect the outcome assessments and assume data entry and analysis, will stay blinded to treatment allocations.

Study Groups

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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.

Group Type EXPERIMENTAL

Mentis Plus+ (Experimental Group)

Intervention Type 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 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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Administração Regional de Saúde do Norte, Portugal

OTHER

Sponsor Role collaborator

Carme Ferré Grau

OTHER

Sponsor Role lead

Responsible Party

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Carme Ferré Grau

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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ACES Cavado I

Braga, , Portugal

Site Status RECRUITING

Countries

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Portugal

Facility Contacts

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Sónia Teixeira, Master

Role: primary

919600975

Paula Machado, Nurse

Role: backup

925062991

References

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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.

Reference Type DERIVED
PMID: 39359154 (View on PubMed)

Other Identifiers

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2020PMHP.PT

Identifier Type: -

Identifier Source: org_study_id