Clinical trial NCT05086198: Two Recovery Strategies at Work, Based on Mindfulness and Physical Exercise, on Levels of Job Stress
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
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness
Keywords: mindfulness
physical exercise
meditation
mental health
stress
recovery
positive and negative affect
work performance
affective job satisfaction
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
name: Universidad de Zaragoza
name: Ministerio de Ciencia e Innovación, Spain
First posted: 2021-10-20
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in General Health with six time points data.
timeFrame: Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
measure: Change in stress with six time points data.
timeFrame: Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
measure: Change in Affective Job Satisfaction with six time points data.
timeFrame: Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
measure: Change in Need for Recovery with six time points data.
timeFrame: Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
measure: Change in Individual Work Performance with six time points data.
timeFrame: Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
measure: Change in Positive and Negative Affect with six time points data.
timeFrame: 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 outcomes:
measure: Change in Fatigue (single-item measure from the Single-Item Fatigue Measure).
timeFrame: 4 days per week during the 8-week interventions
measure: Change in Psychological distancing (item n. 3 from the Recovery Experience Questionnaire).
timeFrame: 4 days per week during the 8-week interventions
measure: Change in Sleep (item n. 6 from the Pittsburg Sleep Quality Index).
timeFrame: 4 days per week during the 8-week interventions
measure: Change in Work stress (single-item measure from the Single-item Measure of Stress Symptoms).
timeFrame: 4 days per week during the 8-week interventions
measure: Change in Mindfulness (item n. 3 from the Five Facets Mindfulness Questionnaire).
timeFrame: 4 days per week during the 8-week interventions
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Sara Cuerva Navas
Study officials:
affiliation: UNED
name: Miguel Santed, PhD
role: PRINCIPAL_INVESTIGATOR
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