Download Study

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:

05/16/2024

Study Status:

In Development

Location(s):

Colombia

Abstract:

La promoción de una salud mental positiva en los entornos laborales es crucial para disminuir los altos niveles de trastornos mentales, como la ansiedad, la depresión y el estrés, que afectan el desempeño laboral de las personas. Si bien existen estrategias del gobierno colombiano para abordar la salud mental, como el proyecto “Salud Mental para Todos” y líneas de atención, las acciones de promoción y prevención en salud mental positiva en las organizaciones colombianas son escasas. Es necesario promover programas de intervención en esta área, especialmente en Colombia, donde existe preocupación por la salud mental en el entorno laboral. El presente estudio es un programa de intervención formativa en Salud Mental Positiva y Florecimiento Ocupacional en las empresas colombianas, como mecanismo de prevención y promoción en salud mental en el trabajo.

Change History for Abstract

Changed On

Previous Value

05/16/2024

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:

Deckard Technologies; García y Asociados

Change History for Name of Partner Institution

Changed On	Previous Value
05/16/2024	Mitsubichi electronics

Type of Organization:

Other

Location:

Colombia

Intervention

Intervention Overview

Intervention:

Los participantes elegibles serán asignados al azar en proporciones iguales entre el Grupo Experimental (EG) [El destinatario del programa PIFE-SMPOyFL] y el Grupo de Control Activo (ACG), recibiendo cada grupo Inicialmente las dos Pruebas SMPO y FL en una primera fase a modo de pretest. El grupo denominado Grupo Experimental recibirá formación en SMPO durante las 6 primeras sesiones, en las que se les dará en una sesión de una hora la explicación de los conceptos que son directamente tributarios de los 6 factores que componen las 4 dimensiones de SMPO. Las 4 sesiones restantes se basarán en los 4 factores de Florecimiento. Cada sesión está diseñada para informar, enseñar y compartir experiencias significativas sobre cada aspecto o factor, videos cortos presentarán experiencias reflexivas y actividades de taller que se resolverán en 10 a 15 minutos. Asimismo, se darán indicaciones de que durante la semana el participante deberá realizar actividades directamente relacionadas con el aspecto aprendido para aplicarlo en su vida diaria, llenando formularios digitales de cumplimiento de actividades y superación de logros de actividades cumplimentadas con reporte diario de manera digital. Los participantes de GCA recibirán capacitación relacionada sobre Inteligencia Emocional. De manera similar, los participantes deberán completar un formulario semanal en el que deberán cumplir con las tareas asignadas, en la primera semana se les indicará a los participantes que escriban tres eventos diarios todas las noches durante la semana 1. La segunda semana deberán escribir la primera. recuerdos del día durante la semana todas las noches; y en la tercera semana, se pide a los participantes de GCA que escriban cada noche de la semana al menos 3 eventos que ocurrieron cada día.

Change History for Intervention

Changed On

Previous Value

05/16/2024

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:

Un programa como el propuesto en la presente intervención en SMPO y FL es crucial, por tanto, se centra en fortalecer los aspectos positivos en los individuos para reducir los elevados niveles de ansiedad, depresión, estrés y otros trastornos mentales observados en el trabajo. contextos. (Vázquez-Colunga, et al., 2017) destacan la importancia de una transición hacia la psicología positiva para fomentar círculos virtuosos que permitan a las personas apreciar los aspectos positivos de sus vidas. Además, se hace hincapié en la necesidad de promover la psicología positiva en todos los entornos donde las personas pasan la mayor parte de su tiempo, incluido el lugar de trabajo (Trejos-Gil & Llano-Castaño, 2023). Y Florecer implica vivir una vida plena y satisfactoria, en la que se combinan eficientemente rendimiento y bienestar emocional. Se trata de lograr una condición que connota bondad, generosidad, crecimiento, resiliencia, manejo adecuado de las emociones, compromiso, relaciones positivas, sentido a la vida y logro, que se traduzca en altos niveles de bienestar emocional, psicológico y social. Es importante señalar que, en general, las personas con peor salud mental tienen más probabilidades de tener dolencias físicas y desarrollar enfermedades mentales y crónicas, lo que se traduce en un mayor uso de servicios médicos, una mayor probabilidad de morir y perder más días de trabajo (C. Keyes, 2002).

Change History for Theory of Change

Changed On

Previous Value

05/16/2024

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 implemented in this doctoral thesis to achieve the stated objective is based on a positivist paradigm, with an empirical-analytical approach under the hypothetical-deductive method. This work is an experimental randomized study based on the CONSORT guidelines for non-drug human clinical trials (Grant et al., 2018). The total minimum sample size is expected to be 18 participants (n=18) distributed in a 1:1 ratio according to the computer-generated randomization program stratified by the Research Randomizer software, resulting in both groups having equal proportions of the same number of randomized participants. The number of participants is representative for conducting clinical trials of this type. The 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. Additionally, to account for data loss, treatment dropout, or invalid data, an additional 20% should be estimated in the sample, resulting in an ideal total sample of 22 participants.

Questionnaires in the pretest and posttest process:

Occupational Positive Mental Health Scale (OPMH-40) pretest and posttest

Flourishing Scale (FI and SFI) pretest and posttest

The trial consists of a 1-week eligibility phase. The total trial period will be approximately 3 months. Measurements will be taken at 2 time points in each group after signing the informed consent: the first before starting the program, and the second immediately after completing the 10-week training program, which constitutes the final posttest measurement.

Change History for Details of Evaluation Approach

Changed On

Previous Value

05/16/2024

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):

Los constructos considerados fueron: SMPO, Programa de Florecimiento y Formación Empresarial. Estos constructos se constituyen como variables dependientes e independientes; asimismo, estos se relacionan en términos de resultados primarios y secundarios como lo sugieren las guías CONSORT (Grant et al., 2018) que se describen a continuación: 
- Variables dependientes: Salud Mental Positiva Ocupacional [Instrumento - (SMPO-40)] y Florecimiento [ Instrumento - Índice floreciente (FI)].
- Variable Independiente: Programa de formación emprendedora (PIFE-SMPOyF).
- Vínculos Primarios: SMPO y Florecimiento
- Vínculos Secundarios: Programa de Formación Empresarial (PIFE-SMPOyF).

Change History for Outcomes (Endpoints)

Changed On

Previous Value

05/16/2024

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:

Hipótesis de investigación: 
H1: El innovador programa de formación corporativa (PIF-SMPOyF) para puestos administrativos provocará un mayor efecto en las variables Salud Mental Ocupacional Positiva y Florecimiento a diferencia del primer test en los colaboradores.

H2: La comparación del grupo experimental y el grupo de control demostrará niveles significativos de cambio en OPMH y Flourishing. 
 

Change History for Hypotheses

Changed On	Previous Value
05/16/2024	Hipótesis de investigación:  H1: El innovador programa de formación corporativa (PIF-SMPOyF) para puestos administrativos provocará un mayor efecto en las variables Salud Mental Ocupacional Positiva y Florecimiento frente al grupo estándar de colaboradores. H2: La comparación del grupo experimental y el grupo de control demostrará niveles significativos de cambio en OPMH y Flourishing.
05/16/2024	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:

18

Change History for Number of Individuals in Sample

Changed On	Previous Value
05/16/2024	100

Size of Treatment, Control, or Comparison Subsamples:

9 individuals in the Experimental Group in the business training intervention program in SMPO and FL; and 9 individuals in the active control group with the working memory training program.

Change History for Size of Treatment, Control, or Comparison Subsamples

Changed On	Previous Value
05/16/2024	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: