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Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.

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ClinicalTrials.gov Identifier: NCT02867657
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : February 8, 2018
Sponsor:
Collaborators:
University of Copenhagen
University of Aarhus
Information provided by (Responsible Party):
VIA University College

Brief Summary:

The purpose of the study is to determine whether a five day mindfulness retreat in nature can increase measures of attention and self-compassion, and reduce stress among bachelor students at Danish Universities and University Colleges. Secondary whether the expression of inflammatory markers can be reduced .

It is the hypothesis that perceived stress is reduced and the expression of genetic markers of inflammation is reduced after a five day mindfulness retreat.


Condition or disease Intervention/treatment Phase
Stress, Psychological Inflammation Stress, Physiological Behavioral: Mindfulness Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Enhancement of Presence, Compassion and Resilience Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.
Study Start Date : June 2016
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Mindfulness in nature
A five day mindfulness retreat in nature
Behavioral: Mindfulness
Five days MBSR curriculum with meditation and yoga
Other Names:
  • Mindfulness Based Stress Reduction
  • MBSR

Active Comparator: Mindfulness indoor
A five day mindfulness retreat indoor
Behavioral: Mindfulness
Five days MBSR curriculum with meditation and yoga
Other Names:
  • Mindfulness Based Stress Reduction
  • MBSR

No Intervention: Wait list control
A wait list control group, that 6 months later is offered a two-day mindfulness retreat in nature



Primary Outcome Measures :
  1. Perceived Stress Scale [ Time Frame: At the end of five days retreat ]
    PSS

  2. Self-compassion [ Time Frame: At the end of five days retreat ]
    S-C-S Neff2


Secondary Outcome Measures :
  1. Five Facet Mindfulness Questionnaire [ Time Frame: At the end of five days retreat ]
  2. Breath Counting [ Time Frame: At the end of five days retreat ]
    Behavioral measurement of attention

  3. NF-kB gene expression [ Time Frame: At the end of five days retreat ]
  4. IL-1 gene expression [ Time Frame: At the end of five days retreat ]
  5. IL-6 gene expression [ Time Frame: At the end of five days retreat ]
  6. cRP expression [ Time Frame: At the end of five days retreat ]
    c reactive protein

  7. Heart Rate Variability [ Time Frame: At the end of five days retreat ]
    HRV

  8. Blood pressure [ Time Frame: At the end of five days retreat ]
  9. Connectedness to Nature Scale [ Time Frame: At the end of five days retreat ]
  10. GR gene expression [ Time Frame: At the end of five days retreat ]
  11. RIPK2 gene expression [ Time Frame: At the end of five days retreat ]
  12. TNF-α gene expression [ Time Frame: At the end of five days retreat ]
  13. CCL5 gene expression [ Time Frame: At the end of five days retreat ]
  14. IL-8 gene expression [ Time Frame: At the end of five days retreat ]
  15. TERT gene expression [ Time Frame: At the end of five days retreat ]
  16. TERC gene expression [ Time Frame: At the end of five days retreat ]
  17. IL-1β protein expression [ Time Frame: At the end of five days retreat ]
  18. IL-2 protein expression [ Time Frame: At the end of five days retreat ]
  19. IL-4 protein expression [ Time Frame: At the end of five days retreat ]
  20. IL-6 protein expression [ Time Frame: At the end of five days retreat ]
  21. IL-8 protein expression [ Time Frame: At the end of five days retreat ]
  22. IL-10 protein expression [ Time Frame: At the end of five days retreat ]
  23. IL-12p70 protein expression [ Time Frame: At the end of five days retreat ]
  24. IL-13 protein expression [ Time Frame: At the end of five days retreat ]
  25. TNF-α protein expression [ Time Frame: At the end of five days retreat ]
  26. IFN-γ protein expression [ Time Frame: At the end of five days retreat ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Bachelor student at a Danish University or University College
  • A score of 16 or above on the Perceived Stress Scale (PSS)

Exclusion Criteria:

  • Smoking
  • Psychiatric diagnosis (depression, anxiety, adjustment disorder, PTSD, personality disorder, psychosis).
  • Untreated ADHD, autism, abuse and risk of suicide

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867657


Contacts
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Contact: Jesper Dahlgaard, PhD +45 8755 2992 jesd@via.dk

Locations
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Denmark
VIA University College Recruiting
Aarhus, Denmark, DK-8200
Contact: Jesper Dahlgaard, PhD    +45 8755 2992    jesd@via.dk   
Nacadia, University of Copenhagen Recruiting
Hoersholm, Denmark, 2970
Contact: Dorthe Djernis, Psychologist    +45 61688011    ddj@ign.ku.dk   
Sponsors and Collaborators
VIA University College
University of Copenhagen
University of Aarhus

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Responsible Party: VIA University College
ClinicalTrials.gov Identifier: NCT02867657     History of Changes
Other Study ID Numbers: H-15010925
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Inflammation
Fatigue
Stress, Psychological
Mental Fatigue
Pathologic Processes
Signs and Symptoms
Behavioral Symptoms