Mental Health WellnessERMENCT05086198

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

A study testing Mindfulness-based intervention and Physical exercise in people with Mental Health Wellness, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Mental Health Wellness
What is being tested?: Mindfulness-based intervention and Physical exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 181 participants
Where: 1 siteSpain
Study dates: 1 Oct 2021to 16 May 2022
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

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Sara Cuerva Navas
Madrid, 28050

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions: Mental Health Wellness
Being tested: Mindfulness-based intervention, Physical exercise
Keywords: mindfulness, physical exercise, meditation, mental health, stress, recovery, positive and negative affect, work performance, affective job satisfaction
Medical subject headings: Motor Activity, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-based interventionBehavioural
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 exerciseBehavioural
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.

Study groups in NCT05086198
Study group	Role	What they receive
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. Receives: 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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
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".
Measured: 4 days per week during the 8-week interventions
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".
Measured: 4 days per week during the 8-week interventions
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)
Measured: 4 days per week during the 8-week interventions
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".
Measured: 4 days per week during the 8-week interventions
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".
Measured: 4 days per week during the 8-week interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202116 May 2022

First posted20 Oct 2021
Study start1 Oct 2021
Primary completion2 Dec 2021
Study completion16 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Mental Health WellnessStudies 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: Treatment
Allocation: Randomised
Intervention model: Factorial
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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 181 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05086198
Sponsor's protocol ID: PID2019-110490RB-I00 (1)
Acronym: ERME
Status last verified: May 2022
First submitted: 28 Sep 2021
Last updated: 18 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
PubMed 25053754
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.
PubMed 17173204
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.
PubMed 24395196
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.
PubMed 23276118
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.
PubMed 7042457
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 28358572
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.
PubMed 27642375
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.
PubMed 26111942
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.
PubMed 22352291
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.
PubMed 23678931
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.
PubMed 31013640
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.
PubMed 29937748
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.
PubMed 16497863
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.
PubMed 16443717
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.
PubMed 2748771

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05086198
Acronym / sponsor ID: ERME / PID2019-110490RB-I00 (1)
Conditions: Mental Health Wellness
Keywords: mindfulness, physical exercise, meditation, mental health, stress, recovery, positive and negative affect, work performance
Study type: Interventional
Recruitment status: Completed
Enrolment: 181 participants (actual)
Lead sponsor: Universidad Nacional de Educación a DistanciaUniversity, hospital or other
Collaborators: Universidad Rey Juan Carlos, Universidad de Zaragoza, Ministerio de Ciencia e Innovación, Spain
Study start: 1 Oct 2021 (actual)
Primary completion: 2 Dec 2021 (actual)
Study completion: 16 May 2022 (actual)
First posted: 20 Oct 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
Mindfulness-based intervention (MBI)	Experimental	Behavioral: Mindfulness-based interventionA 8-week mindfulness-based intervention. From 15 to 30 minutes of practice per session, three times/week through audio guided meditations.
Physical exercise (PE)	Active comparator	Behavioral: Physical exerciseA 8-week physical exercise intervention. From 15 to 30 minutes of practice per session, three times/week through workout videos.
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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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.

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-based interventionAn 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.	Behavioural	Mindfulness-based intervention (MBI)
Physical exerciseAn 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.	Behavioural	Physical exercise (PE)

Primary outcome

Change in General Health with six time points data.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.

5 secondary outcomes

Change in Fatigue (single-item measure from the Single-Item Fatigue Measure).
Time frame: 4 days per week during the 8-week interventions
Change in Psychological distancing (item n. 3 from the Recovery Experience Questionnaire).
Time frame: 4 days per week during the 8-week interventions
Change in Sleep (item n. 6 from the Pittsburg Sleep Quality Index).
Time frame: 4 days per week during the 8-week interventions
Change in Work stress (single-item measure from the Single-item Measure of Stress Symptoms).
Time frame: 4 days per week during the 8-week interventions
Change in Mindfulness (item n. 3 from the Five Facets Mindfulness Questionnaire).
Time frame: 4 days per week during the 8-week interventions

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 18 May 2022.
Background: PubMed 25053754Sharma 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.
Background: PubMed 17173204Geurts 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.
Background: PubMed 24395196Goyal 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.
Background: PubMed 23276118Hulsheger 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.
Background: PubMed 7042457Kabat-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.
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 27642375de 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.
Background: PubMed 26111942van 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.
Background: PubMed 22352291Wolever 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.
Background: PubMed 23678931Heikkila 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.
Results publication: PubMed 31013640Carral 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.
Results publication: PubMed 29937748Fernandez-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.
Assessing Job Performance Using Brief Self-report Scales: The Case of the Individual Work Performance QuestionnaireLink provided by the sponsor.
PANAS scale of positive and negative affect: factor validation and cross-cultural convergenceLink provided by the sponsor.
Psychometric properties and normative values of the General Health Questionnaire (GHQ-12) in the general Spanish populationLink provided by the sponsor.
European Agency for Safety and Health at WorkLink provided by the sponsor.
Individual participant dataSharing planned: No. 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.

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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 Santed, PhD principal investigator

UNED

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-based intervention and Physical exercise in people with Mental Health Wellness, 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 2 inclusion and 5 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 18 May 2022. 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?

Change in General Health with six time points data. (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). The study lists 6 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 NCT05086198, which also lists 18 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 18 May 2022.