StressNCT03728062
Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence
A study testing Mindfulness meditation and Physical exercise in people with Stress and Health Knowledge, Attitudes, Practice, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.
Trial summary
The objective of this research project is to examine if including mindfulness meditation or physical exercise at lunch break improve workers' recovery from work stress. Therefore, 72 workers included either mindfulness meditation or physical exercise during their lunchbreaks for a month in order to find out if these… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Health Knowledge, Attitudes, Practice
- What is being tested?
- Mindfulness meditation and Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 4 Sep 2017to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Knowledge-workers of an specific company with similar stress level.
Who cannot join
- Serious illness
- Regular meditation
- Regular physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness Meditation vs. Physical Exercise as Internal Recovery Strategies: Study on Comparative Effects on Stress, Fatigue, Burnout, Sleep Quality and Immunocompetence. A Randomized Controlled Trial
The objective of this research project is to examine if including mindfulness meditation or physical exercise at lunch break improve workers' recovery from work stress. Therefore, 72 workers included either mindfulness meditation or physical exercise during their lunchbreaks for a month in order to find out if these recovery strategies have more favorable outcomes than usually spent lunch breaks concerning: a) psychological detachment, b) perceived stress, c) general health, d) burnout, e) fatigue, f) quality of sleep, g) cortisol awakening response and h) immunocompetence.
Read the detailed description
The investigators conduct an intervention study in a sample of 72 knowledge-workers, who engaged in mindfulness meditation or physical activities for five weeks. They performed from 15 to 30 minutes during their lunch breaks. The investigators randomly assigned participants to three experimental conditions: 1) mindfulness meditation, 2) physical activity, 3) control group (lunch break as usual). Online questionnaires before and after intervention assessed long term changes regarding recovery processes, perceived stress, health, mindfulness and burnout. For daily changes, a mobile application was developed to assess changes once per day immediately after work. The investigators also collect saliva samples to map cortisol and immunoglobulin A excretion across the intervention period. The investigators had two follow-up measures one and six months after the intervention.
- Conditions
- Stress, Health Knowledge, Attitudes, Practice
- Being tested
- Mindfulness meditation, Physical exercise
- Keywords
- Mindfulness, Physical exercise, Salivary Immunoglobulin A, Recovery strategy from stress
- Medical subject headings
- Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
Also called Mindfulness based intervention (MBSR)
Guided mindfulness meditation focused on breath sensations, thoughts and emotions.
Physical exerciseBehavioural
Also called Cardio exercise
Cardio exercise at gym like rowing, eliptical, cycling, or running outside.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness meditation during lunch break | Experimental | Participants performed mindfulness meditation during lunch break at work place for a month, beginning with 15 minutes and ending with 30 minutes. They had available a "quiet room" and mp3 audios with guided meditations based on the MBSR program. Receives: Behavioral: Mindfulness meditation |
| Physical exercise during lunch break | Experimental | Participants performed physical exercises during lunch break at a gym for a month, beginning with 15 minutes and ending with 30 minutes. They were instructed to do cardio exercise such as running through a park or going to the gym for running, rowing, cycling or elliptical exercise. 20-140 beats per minute must be reach. Receives: Behavioral: Physical exercise |
| Control group | No intervention | Participants continue their normal lunch routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spanish version of the Perceived Stress Questionnaire of Levenstein
Validation of the Spanish version of the Perceived Stress Questionnaire of Levenstein et al. (1993). It is a scale to measure stress in psychosomatic disorders. It consists of 30 items, with Likert responses from 1(almost never) to 4 (almost always). The Spanish version has 6 factors: Harrassment-social acceptance, Overload, Irritability-tension-fatigue, Energy-Joy, Fear-anxiety, Self-realization-satisfaction. The higher score, the higher perceived stress.
Measured: 8 months
Recovery Experience Questionnaire (Sonnentag et al., 2007)
Recovery Experience Questionnaire (Sonnentag et al. 2007) is a measure for assessing recuperation from work. It has 16 items divided into four subscales: psychological detachment, relaxation, mastery and control. Each subscale has 4 items. Every items has a 5-point scale from 1 (I do not agree al all) to 5 (I fully agree). Higher scores indicates a higher degree of recovery from work stress.
Measured: 8 months
Spanish version of the General Health Questionnaire (Goldberg et al., 1997)
Short version of General Health questionnaire. It has 12 items divided into three subscales: Stress, Coping strategies and Self-steem. Every item has a Likert scale to answer from 0 to 3. Higher scores indicates worse general health.
Measured: 8 months
Salivary Immunoglobulin A
Level changes from Baseline to 1 month follow-up. Samples were collected in Salivettes -trademark- (a plastic tube with a swab) twice a day: in the morning (round 7am) and after work (round 7pm). There were collected two Salivettes every of the three moment of measuring (pretest, postest and 1 month follow-up). That means there were taken 6 tubes for every participant.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start4 Sep 2017
- Primary completion1 Nov 2017
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Educación a Distancia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos, Universidad de Zaragoza
- Responsible party
- Sponsor
- Investigators
- Miguel Angel Santed Germán, PhD, Study director, Universidad Nacional Española a DistanciaCarlos María Alcover de las Heras, PhD, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728062
- Sponsor's protocol ID
- 0709201711717
- Status last verified
- Jul 2018
- First submitted
- 11 Oct 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28358572Bliese PD, Edwards JR, Sonnentag S. Stress and well-being at work: A century of empirical trends reflecting theoretical and societal influences. J Appl Psychol. 2017 Mar;102(3):389-402. doi: 10.1037/apl0000109. Epub 2017 Jan 26.
PubMed 28125263Sonnentag S, Arbeus H, Mahn C, Fritz C. Exhaustion and lack of psychological detachment from work during off-job time: moderator effects of time pressure and leisure experiences. J Occup Health Psychol. 2014 Apr;19(2):206-16. doi: 10.1037/a0035760. Epub 2014 Mar 17.
PubMed 24635737Nagel IJ, Sonnentag S. Exercise and sleep predict personal resources in employees' daily lives. Appl Psychol Health Well Being. 2013 Nov;5(3):348-68. doi: 10.1111/aphw.12014. Epub 2013 Oct 8.
PubMed 24395817Hahn VC, Binnewies C, Sonnentag S, Mojza EJ. Learning how to recover from job stress: effects of a recovery training program on recovery, recovery-related self-efficacy, and well-being. J Occup Health Psychol. 2011 Apr;16(2):202-16. doi: 10.1037/a0022169.
PubMed 21463049Sanz-Vergel AI, Sebastian J, Rodriguez-Munoz A, Garrosa E, Moreno-Jimenez B, Sonnentag S. [Adaptation of the "Recovery Experience Questionnaire" in a Spanish sample]. Psicothema. 2010 Nov;22(4):990-6. Spanish.
PubMed 21044543Hulsheger UR, Walkowiak A, Thommes MS. How can mindfulness be promoted? Workload and recovery experiences as antecedents of daily fluctuations in mindfulness. J Occup Organ Psychol. 2018 Jun;91(2):261-284. doi: 10.1111/joop.12206. Epub 2018 Mar 4.
PubMed 29861554Jamieson SD, Tuckey MR. Mindfulness interventions in the workplace: A critique of the current state of the literature. J Occup Health Psychol. 2017 Apr;22(2):180-193. doi: 10.1037/ocp0000048. Epub 2016 Sep 19.
PubMed 27643606Daubenmier J, Hayden D, Chang V, Epel E. It's not what you think, it's how you relate to it: dispositional mindfulness moderates the relationship between psychological distress and the cortisol awakening response. Psychoneuroendocrinology. 2014 Oct;48:11-8. doi: 10.1016/j.psyneuen.2014.05.012. Epub 2014 May 27.
PubMed 24971591Leicht CA, Goosey-Tolfrey VL, Bishop NC. Exercise intensity and its impact on relationships between salivary immunoglobulin A, saliva flow rate and plasma cortisol concentration. Eur J Appl Physiol. 2018 Jun;118(6):1179-1187. doi: 10.1007/s00421-018-3847-6. Epub 2018 Apr 7.
PubMed 29627864Kobayashi H, Song C, Ikei H, Park BJ, Kagawa T, Miyazaki Y. Diurnal Changes in Distribution Characteristics of Salivary Cortisol and Immunoglobulin A Concentrations. Int J Environ Res Public Health. 2017 Aug 31;14(9):987. doi: 10.3390/ijerph14090987.
PubMed 28858222Moreira A, Freitas CG, Nakamura FY, Drago G, Drago M, Aoki MS. Effect of match importance on salivary cortisol and immunoglobulin A responses in elite young volleyball players. J Strength Cond Res. 2013 Jan;27(1):202-7. doi: 10.1519/JSC.0b013e31825183d9.
PubMed 22395269
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation vs. Physical Exercise as Internal Recovery Strategies: Study on Comparative Effects on Stress, Fatigue, Burnout, Sleep Quality and Immunocompetence. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03728062
- Acronym / sponsor ID
- 0709201711717
- Conditions
- Stress, Health Knowledge, Attitudes, Practice
- Keywords
- Mindfulness, Physical exercise, Salivary Immunoglobulin A, Recovery strategy from stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universidad Nacional de Educación a DistanciaUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos, Universidad de Zaragoza
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research project is to examine if including mindfulness meditation or physical exercise at lunch break improve workers' recovery from work stress. Therefore, 72 workers included either mindfulness meditation or physical exercise during their lunchbreaks for a month in order to find out if these recovery strategies have more favorable outcomes than usually spent lunch breaks concerning: a) psychological detachment, b) perceived stress, c) general health, d) burnout, e) fatigue, f) quality of sleep, g) cortisol awakening response and h) immunocompetence.
Detailed description
The investigators conduct an intervention study in a sample of 72 knowledge-workers, who engaged in mindfulness meditation or physical activities for five weeks. They performed from 15 to 30 minutes during their lunch breaks. The investigators randomly assigned participants to three experimental conditions: 1) mindfulness meditation, 2) physical activity, 3) control group (lunch break as usual). Online questionnaires before and after intervention assessed long term changes regarding recovery processes, perceived stress, health, mindfulness and burnout. For daily changes, a mobile application was developed to assess changes once per day immediately after work. The investigators also collect saliva samples to map cortisol and immunoglobulin A excretion across the intervention period. The investigators had two follow-up measures one and six months after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness meditation during lunch break | Experimental | Behavioral: Mindfulness meditationParticipants performed mindfulness meditation during lunch break at work place for a month, beginning with 15 minutes and ending with 30 minutes. They had available a "quiet room" and mp3 audios with guided meditations based on the MBSR program. |
| Physical exercise during lunch break | Experimental | Behavioral: Physical exerciseParticipants performed physical exercises during lunch break at a gym for a month, beginning with 15 minutes and ending with 30 minutes. They were instructed to do cardio exercise such as running through a park or going to the gym for running, rowing, cycling or elliptical exercise. 20-140 beats per minute must be reach. |
| Control group | No intervention | –Participants continue their normal lunch routine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Knowledge-workers of an specific company with similar stress level.
Key exclusion criteria (3 listed)
- Serious illness
- Regular meditation
- Regular physical exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness meditationAlso: Mindfulness based intervention (MBSR)Guided mindfulness meditation focused on breath sensations, thoughts and emotions. | Behavioural | Mindfulness meditation during lunch break |
| Physical exerciseAlso: Cardio exerciseCardio exercise at gym like rowing, eliptical, cycling, or running outside. | Behavioural | Physical exercise during lunch break |
Primary outcome
Spanish version of the Perceived Stress Questionnaire of Levenstein
Time frame: 8 months
Validation of the Spanish version of the Perceived Stress Questionnaire of Levenstein et al. (1993). It is a scale to measure stress in psychosomatic disorders. It consists of 30 items, with Likert responses from 1(almost never) to 4 (almost always). The Spanish version has 6 factors: Harrassment-social acceptance, Overload, Irritability-tension-fatigue, Energy-Joy, Fear-anxiety, Self-realization-satisfaction. The higher score, the higher perceived stress.
Recovery Experience Questionnaire (Sonnentag et al., 2007)
Time frame: 8 months
Recovery Experience Questionnaire (Sonnentag et al. 2007) is a measure for assessing recuperation from work. It has 16 items divided into four subscales: psychological detachment, relaxation, mastery and control. Each subscale has 4 items. Every items has a 5-point scale from 1 (I do not agree al all) to 5 (I fully agree). Higher scores indicates a higher degree of recovery from work stress.
Spanish version of the General Health Questionnaire (Goldberg et al., 1997)
Time frame: 8 months
Short version of General Health questionnaire. It has 12 items divided into three subscales: Stress, Coping strategies and Self-steem. Every item has a Likert scale to answer from 0 to 3. Higher scores indicates worse general health.
Salivary Immunoglobulin A
Time frame: 1 months
Level changes from Baseline to 1 month follow-up. Samples were collected in Salivettes -trademark- (a plastic tube with a swab) twice a day: in the morning (round 7am) and after work (round 7pm). There were collected two Salivettes every of the three moment of measuring (pretest, postest and 1 month follow-up). That means there were taken 6 tubes for every participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Background: PubMed 28358572Sonnentag 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.
- Background: PubMed 28125263Bliese PD, Edwards JR, Sonnentag S. Stress and well-being at work: A century of empirical trends reflecting theoretical and societal influences. J Appl Psychol. 2017 Mar;102(3):389-402. doi: 10.1037/apl0000109. Epub 2017 Jan 26.
- Background: PubMed 24635737Sonnentag S, Arbeus H, Mahn C, Fritz C. Exhaustion and lack of psychological detachment from work during off-job time: moderator effects of time pressure and leisure experiences. J Occup Health Psychol. 2014 Apr;19(2):206-16. doi: 10.1037/a0035760. Epub 2014 Mar 17.
- Background: PubMed 24395817Nagel IJ, Sonnentag S. Exercise and sleep predict personal resources in employees' daily lives. Appl Psychol Health Well Being. 2013 Nov;5(3):348-68. doi: 10.1111/aphw.12014. Epub 2013 Oct 8.
- Background: PubMed 21463049Hahn VC, Binnewies C, Sonnentag S, Mojza EJ. Learning how to recover from job stress: effects of a recovery training program on recovery, recovery-related self-efficacy, and well-being. J Occup Health Psychol. 2011 Apr;16(2):202-16. doi: 10.1037/a0022169.
- Background: PubMed 21044543Sanz-Vergel AI, Sebastian J, Rodriguez-Munoz A, Garrosa E, Moreno-Jimenez B, Sonnentag S. [Adaptation of the "Recovery Experience Questionnaire" in a Spanish sample]. Psicothema. 2010 Nov;22(4):990-6. Spanish.
- Background: PubMed 29861554Hulsheger UR, Walkowiak A, Thommes MS. How can mindfulness be promoted? Workload and recovery experiences as antecedents of daily fluctuations in mindfulness. J Occup Organ Psychol. 2018 Jun;91(2):261-284. doi: 10.1111/joop.12206. Epub 2018 Mar 4.
- Background: PubMed 27643606Jamieson SD, Tuckey MR. Mindfulness interventions in the workplace: A critique of the current state of the literature. J Occup Health Psychol. 2017 Apr;22(2):180-193. doi: 10.1037/ocp0000048. Epub 2016 Sep 19.
- Background: PubMed 24971591Daubenmier J, Hayden D, Chang V, Epel E. It's not what you think, it's how you relate to it: dispositional mindfulness moderates the relationship between psychological distress and the cortisol awakening response. Psychoneuroendocrinology. 2014 Oct;48:11-8. doi: 10.1016/j.psyneuen.2014.05.012. Epub 2014 May 27.
- Background: PubMed 29627864Leicht CA, Goosey-Tolfrey VL, Bishop NC. Exercise intensity and its impact on relationships between salivary immunoglobulin A, saliva flow rate and plasma cortisol concentration. Eur J Appl Physiol. 2018 Jun;118(6):1179-1187. doi: 10.1007/s00421-018-3847-6. Epub 2018 Apr 7.
- Background: PubMed 28858222Kobayashi H, Song C, Ikei H, Park BJ, Kagawa T, Miyazaki Y. Diurnal Changes in Distribution Characteristics of Salivary Cortisol and Immunoglobulin A Concentrations. Int J Environ Res Public Health. 2017 Aug 31;14(9):987. doi: 10.3390/ijerph14090987.
- Background: PubMed 22395269Moreira A, Freitas CG, Nakamura FY, Drago G, Drago M, Aoki MS. Effect of match importance on salivary cortisol and immunoglobulin A responses in elite young volleyball players. J Strength Cond Res. 2013 Jan;27(1):202-7. doi: 10.1519/JSC.0b013e31825183d9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Angel Santed Germán, PhD study director
Universidad Nacional Española a Distancia
Carlos María Alcover de las Heras, PhD study director
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation and Physical exercise in people with Stress and Health Knowledge, Attitudes, Practice, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spanish version of the Perceived Stress Questionnaire of Levenstein (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03728062, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.