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General

Study Overview

Title:

Business Training Intervention Program in Positive Mental Health Ocupational and Flourishing in Colombian companies

Study is 3ie funded:

No

Study ID:

RIDIE-STUDY-ID-64be2e52b75b4

Initial Registration Date:

07/24/2023

Last Update Date:

04/15/2023

Study Status:

In Development

Location(s):

Colombia

Abstract:

The promotion of positive mental health in work environments is crucial to decrease the high levels of mental disorders, such as anxiety, depression and stress, which affect the work performance of individuals. Although there are Colombian government strategies to address mental health, such as the "Mental Health for All" project and lines of care, promotional and preventive actions on positive mental health in Colombian organizations are scarce. There is a need to promote intervention programs in this area, especially in Colombia, where there is concern about mental health in the work environment. The present study is a formative intervention program on Occupational Positive Mental Health and Flourishing in Colombian companies, as a mechanism for prevention and promotion in mental health at work.

Registration Citation:

Categories:

Social Protection
Other

Additional Keywords:

Mental Health, Positive Psychology, Positive Mental Health Ocupational, Companies

Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:

Carlos Andrés Trejos Gil

Affiliation:

Universidad Católica Luis Amigó

Name of Second PI:

Trejos-Gil Carlos Andrés, Trejos-Gil C.A.

Affiliation:

Study Sponsor

Name:

Universidad Católica Luis Amigó

Study Sponsor Location:

Colombia

Research Partner

Name of Partner Institution:

Mitsubichi electronics

Type of Organization:

Other

Location:

Colombia

Intervention

Intervention Overview

Intervention:

Eligible participants will be randomized in equal proportions between the Experimental Group (EG hereafter) [The recipient of the PIFE-SMPOyFL program] and the Active Control Group (ACG hereafter) [The recipient of the placebo program], each group initially receiving the two SMPO and FL tests in a first phase as a pre-test. The group called Experimental Group will be provided with training in SMPO during the first 6 sessions, in which they will be given in a one-hour session the explanation of the concepts that are directly tributary to the 6 factors that compose the 4 dimensions of SMPO. The remaining 4 sessions will be based on the 4 factors of Flourishing. Each session is designed to inform, teach and share meaningful experiences on each aspect or factor, short videos will present reflective experiences, and workshop activities that will be solved in 10 to 15 minutes. Likewise, indications will be given that during the week the participant must perform activities directly related to the aspect learned to apply it in their daily life, filling out digital forms of compliance of activities and overcoming achievements of activities completed with daily report digitally. participants will blindly reinforce each aspect that contribute to the SMPO and FL to finally present the post test and present a positive effect of the program. 

GCA participants will receive related training on Working Memory [to improve work performance]. Similarly, participants will have to fill out a weekly form in which they will have to fulfill the assigned tasks, in the first week participants will be instructed to write three daily events every night during week 1. The second week they are to write the first memories of the day during the week every night; and in the third week, placebo GCA participants are asked to write every night of the week at least 3 events that occurred each day.

Theory of Change:

A program such as the one proposed in the present intervention in SMPO and FL It is crucial, therefore, to focus on strengthening the positive aspects in individuals in order to reduce the elevated levels of anxiety, depression, stress and other mental disorders observed in work contexts. (Vázquez-Colunga, et al., 2017) highlight the importance of a transition towards positive psychology to foster virtuous circles that allow people to appreciate the positive aspects of their lives. In addition, emphasis is placed on the need to promote positive psychology in all environments where people spend most of their time, including the workplace (Trejos-Gil & Llano-Castaño, 2023). And Flourishing implies living a full and satisfying life, in which performance and emotional well-being are effectively combined. It is about achieving a condition that connotes kindness, generosity, growth, resilience, adequate management of emotions, commitment, positive relationships, meaning in life and achievement, which translates into high levels of emotional, psychological and social well-being. It is important to note that, in general, people with poorer mental health are more likely to have physical ailments and develop mental and chronic illnesses, which translates into greater use of medical services, a greater likelihood of dying and missing more days of work (C. Keyes, 2002).

Multiple Treatment Arms Evaluated?

Yes

Implementing Agency

Name of Organization:

Companies in different economic sectors and in their administrative area collaborators

Type of Organization:

Private for profit organization

Program Funder

Name of Organization:

The companies that can participate are sponsors

Type of Organization:

Private for profit organization

Intervention Timing

Intervention or Program Started at time of Registration?

No

Start Date:

05/21/2023

End Date:

10/27/2023

Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:

Randomized control trial

Other (not Listed) Method:

Additional Evaluation Method (If Any):

Other (not Listed) Method:

Method Details

Details of Evaluation Approach:

The methodological design that will be implemented in this doctoral thesis with the purpose of achieving the objective that has been set out, is based on a positivist paradigm, with an analytical empirical approach under the hypothetical deductive method. The present work is a randomized experimental study which is based under the CONSORT Guidelines methodology for non-drug human clinical trials (Grant et al., 2018). 

The minimum total sample is expected to be 100 participants (n=100) distributed in a 1:1 ratio allocation according to the computer-generated randomization program stratified by Research Randomizer software resulting in the two groups with equal proportions of the same number of randomized participants. The number of participants is representative for conducting clinical trials of this type. Sample selection is based on Lipsey and Wilson's (1993) recommendations for mean effect size distributions in educational studies where the control group receives an alternative or traditional treatment. In addition, to account for data loss, treatment dropout, or invalid data, an additional 20% should be estimated in the sample, resulting in an ideal sample total of 120 participants.

Questionnaires in the pre-test and post-test process
- Occupational Positive Mental Health Scale (OPMH-40) pre test and post test
- Flourishing Scale (FI and SFI) pre-test and post-test
The trial consists of a 1-week eligibility phase. The total testing period will be approximately 3 months. Las mediciones se llevarán a cabo en 3 puntos temporales en cada grupo: después de firmar el consentimiento informado, antes de comenzar la inicio del programa, e inmediatamente después de completar las 10 semanas del programa de formación, se realiza la última medición post test.

 

Outcomes (Endpoints):

The constructs considered were: SMPO, Flourishing and Business Training Program. These constructs are constituted as dependent and independent variables; likewise, these are related in terms of primary and secondary outcomes as suggested by the CONSORT guidelines (Grant et al., 2018) described as follows: 
- Dependent variables: Occupational Positive Mental Health [Instrument - (SMPO-40)] and Flourishing [Instrument - Flourishing Index (FI)].
- Independent Variable: Entrepreneurial training program (PIFE-SMPOyF).
- Primary Linkages: SMPO and Flourishing
- Secondary Linkages: Entrepreneurial Training Program (PIFE-SMPOyF).

Unit of Analysis:

Ocupational mental health

Hypotheses:

Research hypothesis: 
- The innovative corporate training program (PIF-SMPOyF) for administrative positions will cause a greater effect on the variables Positive Occupational Mental Health and Flourishing as opposed to the standard group of collaborators.

H2: The comparison of the experimental group and the control group will demonstrate significant levels of change in OPMH and Flourishing. 
H3: There is a positive and direct relationship between SMPO and Languor (a); between Flourishing and SMPO (b); and Languor and Flourishing (c) in the people who were implemented the Intervention Program, as opposed to those who did not use the program. With the cut-off point (> 0.75).

Unit of Intervention or Assignment:

Employees of administrative areas of the companies

Number of Clusters in Sample:

Group intervention

Number of Individuals in Sample:

100

Size of Treatment, Control, or Comparison Subsamples:

50 individuals in the Experimental Group in the business training intervention program in SMPO and FL; and 50 individuals in the active control group with the working memory training program.

Data

Outcomes Data

Description:

The following batteries of scales are implemented beforehand so that the participants do not have a negative clinical history that could alter the results and there is no bias of any kind. -Anxiety and Depression Scale (HADS) -Self-Esteem Scale (RSES) -Work Addiction Scale (BWAS) -Work Stress Burnout Scale (MBI) Questionnaires in the pre-test -Occupational Positive Mental Health Scale (OPMH-40) pretest and posttest -Flourishing Scale (FI and SFI) pre test and post test

Data Already Collected?

No

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Treatment Assignment Data

Participation or Assignment Information:

Yes

Description:

Data Obtained by the Study Researchers?

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:

Prospective, Category 1: Data for measuring impacts have not been collected

Completion

Completion Overview

Intervention Completion Date:

Data Collection Completion Date:

Unit of Analysis:

Clusters in Final Sample:

Total Observations in Final Sample:

Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:

Preliminary Report URL:

Summary of Findings:

Paper:

Paper Summary:

Paper Citation:

Data Availability

Data Availability (Primary Data):

Date of Data Availability:

Data URL or Contact:

Access procedure:

Other Materials

Survey:

Survey Instrument Links or Contact:

Program Files:

Program Files Links or Contact:

External Link:

External Link Description:

Description of Changes:

Study Stopped

Date:

Reason: