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

Mental Health Wellness Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05086198
• Other study ID #: PID2019-110490RB-I00 (1)
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: May 16, 2022

Study information

• Verified date: May 2022
• Source: Universidad Nacional de Educación a Distancia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: May 16, 2022
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Wellness
• Occupational Stress

Intervention

Behavioral:
• Mindfulness-based intervention
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.
• Physical exercise
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.

Locations

Country	Name	City	State
Spain	Sara Cuerva Navas	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Universidad Nacional de Educación a Distancia	Ministerio de Ciencia e Innovación, Spain, Universidad de Zaragoza, Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

References & Publications (18)

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de Bruin EI, van der Zwan JE, Bögels SM. A RCT Comparing Daily Mindfulness Meditations, Biofeedback Exercises, and Daily Physical Exercise on Attention Control, Executive Functioning, Mindful Awareness, Self-Compassion, and Worrying in Stressed Young Adults. Mindfulness (N Y). 2016;7(5):1182-1192. doi: 10.1007/s12671-016-0561-5. Epub 2016 Jul 2. — View Citation

de Croon EM, Sluiter JK, Frings-Dresen MH. Psychometric properties of the Need for Recovery after work scale: test-retest reliability and sensitivity to detect change. Occup Environ Med. 2006 Mar;63(3):202-6. — View Citation

Elo AL, Leppänen A, Jahkola A. Validity of a single-item measure of stress symptoms. Scand J Work Environ Health. 2003 Dec;29(6):444-51. — View Citation

Fernández-Muñoz JJ, Topa G. Older Workers and Affective Job Satisfaction: Gender Invariance in Spain. Front Psychol. 2018 Jun 8;9:930. doi: 10.3389/fpsyg.2018.00930. eCollection 2018. — View Citation

Geurts SA, Sonnentag S. Recovery as an explanatory mechanism in the relation between acute stress reactions and chronic health impairment. Scand J Work Environ Health. 2006 Dec;32(6):482-92. — View Citation

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Heikkilä K, Fransson EI, Nyberg ST, Zins M, Westerlund H, Westerholm P, Virtanen M, Vahtera J, Suominen S, Steptoe A, Salo P, Pentti J, Oksanen T, Nordin M, Marmot MG, Lunau T, Ladwig KH, Koskenvuo M, Knutsson A, Kittel F, Jöckel KH, Goldberg M, Erbel R, Dragano N, DeBacquer D, Clays E, Casini A, Alfredsson L, Ferrie JE, Singh-Manoux A, Batty GD, Kivimäki M; IPD-Work Consortium. Job strain and health-related lifestyle: findings from an individual-participant meta-analysis of 118,000 working adults. Am J Public Health. 2013 Nov;103(11):2090-7. doi: 10.2105/AJPH.2012.301090. Epub 2013 May 16. — View Citation

Hülsheger UR, Alberts HJ, Feinholdt A, Lang JW. Benefits of mindfulness at work: the role of mindfulness in emotion regulation, emotional exhaustion, and job satisfaction. J Appl Psychol. 2013 Mar;98(2):310-25. doi: 10.1037/a0031313. Epub 2012 Dec 31. — View Citation

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Sharma M, Rush SE. Mindfulness-based stress reduction as a stress management intervention for healthy individuals: a systematic review. J Evid Based Complementary Altern Med. 2014 Oct;19(4):271-86. doi: 10.1177/2156587214543143. Epub 2014 Jul 22. Review. — View Citation

Sonnentag S, Fritz C. The Recovery Experience Questionnaire: development and validation of a measure for assessing recuperation and unwinding from work. J Occup Health Psychol. 2007 Jul;12(3):204-21. — View Citation

Sonnentag S, Venz L, Casper A. Advances in recovery research: What have we learned? What should be done next? J Occup Health Psychol. 2017 Jul;22(3):365-380. doi: 10.1037/ocp0000079. Epub 2017 Mar 30. Review. — View Citation

van der Zwan JE, de Vente W, Huizink AC, Bögels SM, de Bruin EI. Physical activity, mindfulness meditation, or heart rate variability biofeedback for stress reduction: a randomized controlled trial. Appl Psychophysiol Biofeedback. 2015 Dec;40(4):257-68. doi: 10.1007/s10484-015-9293-x. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
Primary	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)	Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
Primary	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.	Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
Primary	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.	Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
Primary	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.	Baseline, Post-treatment 8 weeks from baseline, 1-month follow-up, 2-month follow-up,3-months follow-up and 6-months follow-up
Primary	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.	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	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".	4 days per week during the 8-week interventions
Secondary	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".	4 days per week during the 8-week interventions
Secondary	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)	4 days per week during the 8-week interventions
Secondary	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".	4 days per week during the 8-week interventions
Secondary	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".	4 days per week during the 8-week interventions

External Links

•   Assessing Job Performance Using Brief Self-report Scales: The Case of the Individual Work Performance Questionnaire
•   European Agency for Safety and Health at Work
•   PANAS scale of positive and negative affect: factor validation and cross-cultural convergence
•   Psychometric properties and normative values of the General Health Questionnaire (GHQ-12) in the general Spanish population