Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date February 8, 2018
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
  • Perceived Stress Scale [ Time Frame: At the end of five days retreat ]
    PSS
  • Self-compassion [ Time Frame: At the end of five days retreat ]
    S-C-S Neff2
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
Perceived Stress Scale [ Time Frame: At the end of five days retreat ]
Change History Complete list of historical versions of study NCT02867657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
  • Five Facet Mindfulness Questionnaire [ Time Frame: At the end of five days retreat ]
  • Breath Counting [ Time Frame: At the end of five days retreat ]
    Behavioral measurement of attention
  • NF-kB gene expression [ Time Frame: At the end of five days retreat ]
  • IL-1 gene expression [ Time Frame: At the end of five days retreat ]
  • IL-6 gene expression [ Time Frame: At the end of five days retreat ]
  • cRP expression [ Time Frame: At the end of five days retreat ]
    c reactive protein
  • Heart Rate Variability [ Time Frame: At the end of five days retreat ]
    HRV
  • Blood pressure [ Time Frame: At the end of five days retreat ]
  • Connectedness to Nature Scale [ Time Frame: At the end of five days retreat ]
  • GR gene expression [ Time Frame: At the end of five days retreat ]
  • RIPK2 gene expression [ Time Frame: At the end of five days retreat ]
  • TNF-α gene expression [ Time Frame: At the end of five days retreat ]
  • CCL5 gene expression [ Time Frame: At the end of five days retreat ]
  • IL-8 gene expression [ Time Frame: At the end of five days retreat ]
  • TERT gene expression [ Time Frame: At the end of five days retreat ]
  • TERC gene expression [ Time Frame: At the end of five days retreat ]
  • IL-1β protein expression [ Time Frame: At the end of five days retreat ]
  • IL-2 protein expression [ Time Frame: At the end of five days retreat ]
  • IL-4 protein expression [ Time Frame: At the end of five days retreat ]
  • IL-6 protein expression [ Time Frame: At the end of five days retreat ]
  • IL-8 protein expression [ Time Frame: At the end of five days retreat ]
  • IL-10 protein expression [ Time Frame: At the end of five days retreat ]
  • IL-12p70 protein expression [ Time Frame: At the end of five days retreat ]
  • IL-13 protein expression [ Time Frame: At the end of five days retreat ]
  • TNF-α protein expression [ Time Frame: At the end of five days retreat ]
  • IFN-γ protein expression [ Time Frame: At the end of five days retreat ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • Self-compassion scale [ Time Frame: At the end of five days retreat ]
  • Five Facet Mindfulness Questionnaire [ Time Frame: At the end of five days retreat ]
  • Connectedness to Nature Scale [ Time Frame: At the end of five days retreat ]
  • IL-6 gene expression [ Time Frame: At the end of five days retreat ]
  • Telomerase activity [ Time Frame: At the end of five days retreat ]
  • NF-kB gene expression [ Time Frame: At the end of five days retreat ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.
Official Title  ICMJE Enhancement of Presence, Compassion and Resilience Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Stress, Psychological
  • Inflammation
  • Stress, Physiological
Intervention  ICMJE Behavioral: Mindfulness
Five days MBSR curriculum with meditation and yoga
Other Names:
  • Mindfulness Based Stress Reduction
  • MBSR
Study Arms  ICMJE
  • Experimental: Mindfulness in nature
    A five day mindfulness retreat in nature
    Intervention: Behavioral: Mindfulness
  • Active Comparator: Mindfulness indoor
    A five day mindfulness retreat indoor
    Intervention: Behavioral: Mindfulness
  • No Intervention: Wait list control
    A wait list control group, that 6 months later is offered a two-day mindfulness retreat in nature
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jesper Dahlgaard, PhD +45 8755 2992 jesd@via.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867657
Other Study ID Numbers  ICMJE H-15010925
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VIA University College
Study Sponsor  ICMJE VIA University College
Collaborators  ICMJE
  • University of Copenhagen
  • University of Aarhus
Investigators  ICMJE Not Provided
PRS Account VIA University College
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP