NCT05086198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

September 28, 2021

Last Update Submit

May 17, 2022

Conditions

Keywords

mindfulnessphysical exercisemeditationmental healthstressrecoverypositive and negative affectwork performanceaffective job satisfaction

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (5)

  • Change in Fatigue (single-item measure from the Single-Item Fatigue Measure).

    4 days per week during the 8-week interventions

  • Change in Psychological distancing (item n. 3 from the Recovery Experience Questionnaire).

    4 days per week during the 8-week interventions

  • Change in Sleep (item n. 6 from the Pittsburg Sleep Quality Index).

    4 days per week during the 8-week interventions

  • Change in Work stress (single-item measure from the Single-item Measure of Stress Symptoms).

    4 days per week during the 8-week interventions

  • Change in Mindfulness (item n. 3 from the Five Facets Mindfulness Questionnaire).

    4 days per week during the 8-week interventions

Study Arms (3)

Mindfulness-based intervention (MBI)

EXPERIMENTAL

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

Behavioral: Mindfulness-based intervention

Physical exercise (PE)

ACTIVE COMPARATOR

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

Behavioral: Physical exercise

Wait list (WL)

NO INTERVENTION

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

Interventions

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.

Mindfulness-based intervention (MBI)

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.

Physical exercise (PE)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sara Cuerva Navas

Madrid, 28050, Spain

Location

Related Publications (18)

  • 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.

    PMID: 25053754BACKGROUND
  • 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. doi: 10.5271/sjweh.1053.

    PMID: 17173204BACKGROUND
  • Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.

    PMID: 24395196BACKGROUND
  • Hulsheger 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.

    PMID: 23276118BACKGROUND
  • Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.

    PMID: 7042457BACKGROUND
  • 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.

    PMID: 28358572BACKGROUND
  • de Bruin EI, van der Zwan JE, Bogels 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.

    PMID: 27642375BACKGROUND
  • van der Zwan JE, de Vente W, Huizink AC, Bogels 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.

    PMID: 26111942BACKGROUND
  • Wolever RQ, Bobinet KJ, McCabe K, Mackenzie ER, Fekete E, Kusnick CA, Baime M. Effective and viable mind-body stress reduction in the workplace: a randomized controlled trial. J Occup Health Psychol. 2012 Apr;17(2):246-258. doi: 10.1037/a0027278. Epub 2012 Feb 20.

    PMID: 22352291BACKGROUND
  • Heikkila 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, Jockel KH, Goldberg M, Erbel R, Dragano N, DeBacquer D, Clays E, Casini A, Alfredsson L, Ferrie JE, Singh-Manoux A, Batty GD, Kivimaki 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.

    PMID: 23678931BACKGROUND
  • Carral P, Alcover CM. Measuring Age Discrimination at Work: Spanish Adaptation and Preliminary Validation of the Nordic Age Discrimination Scale (NADS). Int J Environ Res Public Health. 2019 Apr 22;16(8):1431. doi: 10.3390/ijerph16081431.

  • Fernandez-Munoz 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.

  • 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. doi: 10.1136/oem.2004.018275.

  • Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  • Elo AL, Leppanen A, Jahkola A. Validity of a single-item measure of stress symptoms. Scand J Work Environ Health. 2003 Dec;29(6):444-51. doi: 10.5271/sjweh.752.

  • 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. doi: 10.1037/1076-8998.12.3.204.

  • van Hooff ML, Geurts SA, Kompier MA, Taris TW. "How fatigued do you currently feel?" Convergent and discriminant validity of a single-item fatigue measure. J Occup Health. 2007 May;49(3):224-34. doi: 10.1539/joh.49.224.

Related Links

MeSH Terms

Conditions

Motor ActivityPsychological Well-Being

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Miguel Santed, PhD

    UNED

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: A randomized controlled trial of three groups is proposed, with pretest, posttest and four follow-ups at 1, 2, 3 and 6 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Clinical Psychologist and Professor

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 20, 2021

Study Start

October 1, 2021

Primary Completion

December 2, 2021

Study Completion

May 16, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

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.

Locations