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Two Recovery Strategies at Work, Based on Mindfulness and Physical Exercise, on Levels of Job Stress (ERME)

Primary Purpose

Mental Health Wellness

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness-based intervention
Physical exercise
Sponsored by
Universidad Nacional de Educación a Distancia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Wellness focused on measuring mindfulness, physical exercise, meditation, mental health, stress, recovery, positive and negative affect, work performance, affective job satisfaction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age from 18 to 65 years.
  • To be a full-time worker (≥35 hours/week).

Exclusion Criteria:

  • Currently practicing any type of meditation regularly.
  • Currently practicing physical activity (aerobic or anaerobic) more than once a week.
  • To have a physical or mental illness that prevents moderate exercise or mindfulness practice.
  • Very low self-perceived work load and responsibility levels.
  • Very low self-perceived stress and work stress levels.

Sites / Locations

  • Sara Cuerva Navas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Mindfulness-based intervention (MBI)

Physical exercise (PE)

Wait list (WL)

Arm Description

A 8-week mindfulness-based intervention. From 15 to 30 minutes of practice per session, three times/week through audio guided meditations.

A 8-week physical exercise intervention. From 15 to 30 minutes of practice per session, three times/week through workout videos.

The participants will continue their work activity as usual. This arm will receive one of the two previous interventions once the study finished.

Outcomes

Primary Outcome Measures

Change in General Health with six time points data.
The General Health Questionnaire (GHQ-12) consists of 12 items. It is a unidimensional measure of psychological distress. It is answered on a Likert-type scale from 1 to 4 (1 = Never and 4 = Always). The score was used to generate a total score ranging from 0 to 36.
Change in stress with six time points data.
A single item was used: Stress refers to a person's situation when they feel tense, restless, nervous, or anxious, or are unable to sleep at night because their mind is constantly preoccupied with work-related issues. Please indicate the extent to which you currently feel this type of stress. It has five possible responses on a Likert-type scale from 1 to 5 (being 1 nothing and 5 a lot)
Change in Affective Job Satisfaction with six time points data.
The Brief Index of Affective Job Satisfaction (BIAJS)-Spanish version (BIAJS) consists of 7 items. It is an overall measure of affective job satisfaction. It measures satisfaction in five facets: promotion, co-workers, work itself, supervision and salary. It is answered on a Likert-type scale from 1 to 5 (1 = Strongly disagree and 5 = Strongly agree). The score was used to generate a total score ranging from 7 to 35.
Change in Need for Recovery with six time points data.
The Need for Recovery (NFR) Scale consists of 9 items. It facilitates the understanding of the factors that can lead to sustainable working and employability. It is answered on a Likert-type scale from 1 to 5 (1 = Never and 5 = Always). The score was used to generate a total score ranging from 1 to 100.Our research team will carry the validation of the Spanish version of NFR.
Change in Individual Work Performance with six time points data.
The Individual Work Performance Questionnaire (IWPQ)-Brief Spanish version (IWPQ) has 18 items. It measures the three main dimensions of job performance: task performance, contextual performance, and counterproductive work behavior. It is answered on a Likert-type scale from 1 to 5 (1 = Never or Seldom and 5 = Always or Often). The score was used to generate a total score ranging from 18 to 90.
Change in Positive and Negative Affect with six time points data.
The PANAS Scales of Positive and Negative Affect (PANAS) - Spanish version has 20 items. It is the most widely used scale of affectivity. It has two dominant dimensions, positive affect (10 items) and negative affect (10 items) It is answered on a Likert-type scale from 1 to 5 (1 = Very slightly or Not at all and 5 = Extremely). The score was used to generate a total score ranging from 20 to 100.

Secondary Outcome Measures

Change in Fatigue (single-item measure from the Single-Item Fatigue Measure).
Single-Item on fatigue level:" Indicate what level of fatigue you felt today". The response is rcorded on a 5-point Likert scale varying from "not at all" to "very much".
Change in Psychological distancing (item n. 3 from the Recovery Experience Questionnaire).
Single-Item on Psychological distancing level: "After work, I have been able to "disconnect". The response is recorded on a 5-point Likert scale varying from "not at all" to "very much".
Change in Sleep (item n. 6 from the Pittsburg Sleep Quality Index).
Single-Item on Sleep: "How did you sleep last night?". The responses are articulated on a Likert-type scale from 1 to 5 (1 = very bad and 5 = very good)
Change in Work stress (single-item measure from the Single-item Measure of Stress Symptoms).
Single-Item on work stress: "Indicate the extent to which you have felt stressed, tense, nervous, or anxious today". The response is recorded on a 5-point Likert scale varying from "not at all" to "very much".
Change in Mindfulness (item n. 3 from the Five Facets Mindfulness Questionnaire).
Single-Item on attention: "Today it has been difficult for me to be attentive to what required my attention at all times". The response is recorded on a 5-point Likert scale varying from "not at all" to "very much".

Full Information

First Posted
September 28, 2021
Last Updated
May 17, 2022
Sponsor
Universidad Nacional de Educación a Distancia
Collaborators
Universidad Rey Juan Carlos, Universidad de Zaragoza, Ministerio de Ciencia e Innovación, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT05086198
Brief Title
Two Recovery Strategies at Work, Based on Mindfulness and Physical Exercise, on Levels of Job Stress
Acronym
ERME
Official Title
Differential Effectiveness of Two Recovery Strategies at Work, Based on Mindfulness and Physical Exercise, on Levels of Job Stress A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
May 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional de Educación a Distancia
Collaborators
Universidad Rey Juan Carlos, Universidad de Zaragoza, Ministerio de Ciencia e Innovación, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study aims to compare the differential effects of a mindfulness-based intervention (MBI) and physical exercise (PE) on different stress and health variables by self-reports. A randomized controlled trial of three groups is proposed, with pretest, posttest and four follow-ups at 1, 2, 3 and 6 months that would be developed among the employees of two large multinationals.
Detailed Description
Work and workplace related problems are common sources of stress. Work-related stress is associated with a decrease in productivity, greater absenteeism, accidents and injuries, mental illness, greater errors, and poor performance, among others, which involve significant financial costs. Therefore, it is crucial to find coping strategies that are effective in reducing such stress. Probably, the most appropriate strategies, for their real possibilities of implementation, for their easy execution, low cost and for the empirical support they have, are mindfulness-based interventions (MBIs) and physical exercise (PE). Both types of practices have shown beneficial effects for physical health, mental health and psychological well-being in general. Different investigations have compared the implementation of MBI and PE, both combined and separately, with interesting results. The main objective is to evaluate the interactive effects of group x time, the intragroup changes and the differences between groups, in the different moments (pretest, posttest, 1, 2, 3 and 6-months follow-up) on general health, stress, affective job satisfaction, recovery, work performance, and positive and negative affect in the three groups considered; an MBI, an aerobic PE program and an inactive control / waiting list (LE) condition will be contrasted. The secondary objective is to evaluate the trend and linear patterns in the change trajectory in the three groups during the eight weeks of intervention on fatigue, psychological distancing, sleep, work stress, and attention. A randomized controlled trial of three groups is proposed, with pretest, posttest and four follow-ups at 1, 2, 3 and 6 months that would be developed among the employees of two large multinationals (N ≥ 150). The primary dependent variables considered are: 1) recovery experiences; 2) perceived stress; 3) general health; 4) affective job satisfaction; 5) individual work performance; and 6) positive and negative affects. The secondary dependent variables considered are daily states of: 1) fatigue, 2) psychological distancing, 3) quality of sleep; 4) work stress; and 5) attention. Sociodemographic data will be collected at baseline (age, gender, level of education, number of economically dependent persons, type of contract, type of working day (split/continuous), workstation type, seniority in the organization, seniority in current position and teleworking modality). The investigators identified two candidate covariates: 1) pharmacological treatment that can influence the psychological state (measured with two alternatives, use / non-use of anxiolytics, hypnotics and other psychotropic drugs); 2) Baseline state of stress and work stress (measured using a single item scale, Likert scale from 1 to 5, 1 being very low and 5 very high) The intervention program is structured for 8 weeks, during which the two intervention groups will carry out their recovery strategy (IBM or EF), starting and increasing the practice 5 minutes every two weeks (weeks 1 and 2, 15 minutes; weeks 3 and 4, 20 minutes; weeks 5 and 6, 25; weeks 7 and 8, 30 minutes). The control group will continue as usual. Record will be taken of recovery strategies that workers perform naturally and spontaneously, and will be compared to strategies guided by interventions, as those the investigators propose. The investigators believe that this study is a quasi-pioneering initiative because of its theme, uses a robust methodology, and will have an important scientific-technical impact. The importance of the topic addressed in terms of health and business productivity is associated with important contributions in terms of knowledge transfer to companies and society in general.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness
Keywords
mindfulness, physical exercise, meditation, mental health, stress, recovery, positive and negative affect, work performance, affective job satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
A randomized controlled trial of three groups is proposed, with pretest, posttest and four follow-ups at 1, 2, 3 and 6 months.
Masking
InvestigatorOutcomes Assessor
Masking Description
Blinding of trial participants and care providers is not possible because of obvious differences between the interventions. However, participants will be blinded in terms of which intervention is considered the experimental one.
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based intervention (MBI)
Arm Type
Experimental
Arm Description
A 8-week mindfulness-based intervention. From 15 to 30 minutes of practice per session, three times/week through audio guided meditations.
Arm Title
Physical exercise (PE)
Arm Type
Active Comparator
Arm Description
A 8-week physical exercise intervention. From 15 to 30 minutes of practice per session, three times/week through workout videos.
Arm Title
Wait list (WL)
Arm Type
No Intervention
Arm Description
The participants will continue their work activity as usual. This arm will receive one of the two previous interventions once the study finished.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based intervention
Intervention Description
An instructor trained in Mindfulness-based Stress Reduction (MBSR; Kabat-Zinn, 1990) will conduct meditations lasting 15 to 30 minutes. The participants will have a mobile application designed ad hoc with the practice of the week so they can do it individually at home.
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise
Intervention Description
An aerobic and fitness trainer will conduct aerobic exercise lasting 15 to 30 minutes. The participants will watch it in a video platform. They will not be able to do anaerobic exercise like weight lifting. The intensity of the chosen exercise will be moderate, maintaining between 120-140 beats per minute.
Primary Outcome Measure Information:
Title
Change in General Health with six time points data.
Description
The General Health Questionnaire (GHQ-12) consists of 12 items. It is a unidimensional measure of psychological distress. It is answered on a Likert-type scale from 1 to 4 (1 = Never and 4 = Always). The score was used to generate a total score ranging from 0 to 36.
Time Frame
Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
Title
Change in stress with six time points data.
Description
A single item was used: Stress refers to a person's situation when they feel tense, restless, nervous, or anxious, or are unable to sleep at night because their mind is constantly preoccupied with work-related issues. Please indicate the extent to which you currently feel this type of stress. It has five possible responses on a Likert-type scale from 1 to 5 (being 1 nothing and 5 a lot)
Time Frame
Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
Title
Change in Affective Job Satisfaction with six time points data.
Description
The Brief Index of Affective Job Satisfaction (BIAJS)-Spanish version (BIAJS) consists of 7 items. It is an overall measure of affective job satisfaction. It measures satisfaction in five facets: promotion, co-workers, work itself, supervision and salary. It is answered on a Likert-type scale from 1 to 5 (1 = Strongly disagree and 5 = Strongly agree). The score was used to generate a total score ranging from 7 to 35.
Time Frame
Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
Title
Change in Need for Recovery with six time points data.
Description
The Need for Recovery (NFR) Scale consists of 9 items. It facilitates the understanding of the factors that can lead to sustainable working and employability. It is answered on a Likert-type scale from 1 to 5 (1 = Never and 5 = Always). The score was used to generate a total score ranging from 1 to 100.Our research team will carry the validation of the Spanish version of NFR.
Time Frame
Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
Title
Change in Individual Work Performance with six time points data.
Description
The Individual Work Performance Questionnaire (IWPQ)-Brief Spanish version (IWPQ) has 18 items. It measures the three main dimensions of job performance: task performance, contextual performance, and counterproductive work behavior. It is answered on a Likert-type scale from 1 to 5 (1 = Never or Seldom and 5 = Always or Often). The score was used to generate a total score ranging from 18 to 90.
Time Frame
Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
Title
Change in Positive and Negative Affect with six time points data.
Description
The PANAS Scales of Positive and Negative Affect (PANAS) - Spanish version has 20 items. It is the most widely used scale of affectivity. It has two dominant dimensions, positive affect (10 items) and negative affect (10 items) It is answered on a Likert-type scale from 1 to 5 (1 = Very slightly or Not at all and 5 = Extremely). The score was used to generate a total score ranging from 20 to 100.
Time Frame
Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
Secondary Outcome Measure Information:
Title
Change in Fatigue (single-item measure from the Single-Item Fatigue Measure).
Description
Single-Item on fatigue level:" Indicate what level of fatigue you felt today". The response is rcorded on a 5-point Likert scale varying from "not at all" to "very much".
Time Frame
4 days per week during the 8-week interventions
Title
Change in Psychological distancing (item n. 3 from the Recovery Experience Questionnaire).
Description
Single-Item on Psychological distancing level: "After work, I have been able to "disconnect". The response is recorded on a 5-point Likert scale varying from "not at all" to "very much".
Time Frame
4 days per week during the 8-week interventions
Title
Change in Sleep (item n. 6 from the Pittsburg Sleep Quality Index).
Description
Single-Item on Sleep: "How did you sleep last night?". The responses are articulated on a Likert-type scale from 1 to 5 (1 = very bad and 5 = very good)
Time Frame
4 days per week during the 8-week interventions
Title
Change in Work stress (single-item measure from the Single-item Measure of Stress Symptoms).
Description
Single-Item on work stress: "Indicate the extent to which you have felt stressed, tense, nervous, or anxious today". The response is recorded on a 5-point Likert scale varying from "not at all" to "very much".
Time Frame
4 days per week during the 8-week interventions
Title
Change in Mindfulness (item n. 3 from the Five Facets Mindfulness Questionnaire).
Description
Single-Item on attention: "Today it has been difficult for me to be attentive to what required my attention at all times". The response is recorded on a 5-point Likert scale varying from "not at all" to "very much".
Time Frame
4 days per week during the 8-week interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age from 18 to 65 years. To be a full-time worker (≥35 hours/week). Exclusion Criteria: Currently practicing any type of meditation regularly. Currently practicing physical activity (aerobic or anaerobic) more than once a week. To have a physical or mental illness that prevents moderate exercise or mindfulness practice. Very low self-perceived work load and responsibility levels. Very low self-perceived stress and work stress levels.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Santed, PhD
Organizational Affiliation
UNED
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sara Cuerva Navas
City
Madrid
ZIP/Postal Code
28050
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators will deposit data sets associated with the research in an Institutional Research Data Repository. If that is not possible, the interested parties may contact the corresponding author of the articles who will provide them with the required information.
Citations:
PubMed Identifier
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Citation
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Links:
URL
https://doi.org/10.5093/jwop2019a21
Description
Assessing Job Performance Using Brief Self-report Scales: The Case of the Individual Work Performance Questionnaire
URL
https://dialnet.unirioja.es/servlet/articulo?codigo=2011515
Description
PANAS scale of positive and negative affect: factor validation and cross-cultural convergence
URL
https://www.redalyc.org/pdf/337/33715423008.pdf
Description
Psychometric properties and normative values of the General Health Questionnaire (GHQ-12) in the general Spanish population
URL
https://www.europarl.europa.eu/factsheets/en/sheet/56/health-and-safety-at-work
Description
European Agency for Safety and Health at Work

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Two Recovery Strategies at Work, Based on Mindfulness and Physical Exercise, on Levels of Job Stress

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