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

Primary Purpose

Stress, Psychological, Inflammation, Stress, Physiological

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
VIA University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stress, Psychological

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VIA University CollegeRecruiting
  • Nacadia, University of CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Mindfulness in nature

Mindfulness indoor

Wait list control

Arm Description

A five day mindfulness retreat in nature

A five day mindfulness retreat indoor

A wait list control group, that 6 months later is offered a two-day mindfulness retreat in nature

Outcomes

Primary Outcome Measures

Perceived Stress Scale
PSS
Self-compassion
S-C-S Neff2

Secondary Outcome Measures

Five Facet Mindfulness Questionnaire
Breath Counting
Behavioral measurement of attention
NF-kB gene expression
IL-1 gene expression
IL-6 gene expression
cRP expression
c reactive protein
Heart Rate Variability
HRV
Blood pressure
Connectedness to Nature Scale
GR gene expression
RIPK2 gene expression
TNF-α gene expression
CCL5 gene expression
IL-8 gene expression
TERT gene expression
TERC gene expression
IL-1β protein expression
IL-2 protein expression
IL-4 protein expression
IL-6 protein expression
IL-8 protein expression
IL-10 protein expression
IL-12p70 protein expression
IL-13 protein expression
TNF-α protein expression
IFN-γ protein expression

Full Information

First Posted
August 10, 2016
Last Updated
February 7, 2018
Sponsor
VIA University College
Collaborators
University of Copenhagen, University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02867657
Brief Title
Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.
Official Title
Enhancement of Presence, Compassion and Resilience Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 1, 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIA University College
Collaborators
University of Copenhagen, University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Inflammation, Stress, Physiological

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness in nature
Arm Type
Experimental
Arm Description
A five day mindfulness retreat in nature
Arm Title
Mindfulness indoor
Arm Type
Active Comparator
Arm Description
A five day mindfulness retreat indoor
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
A wait list control group, that 6 months later is offered a two-day mindfulness retreat in nature
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Other Intervention Name(s)
Mindfulness Based Stress Reduction, MBSR
Intervention Description
Five days MBSR curriculum with meditation and yoga
Primary Outcome Measure Information:
Title
Perceived Stress Scale
Description
PSS
Time Frame
At the end of five days retreat
Title
Self-compassion
Description
S-C-S Neff2
Time Frame
At the end of five days retreat
Secondary Outcome Measure Information:
Title
Five Facet Mindfulness Questionnaire
Time Frame
At the end of five days retreat
Title
Breath Counting
Description
Behavioral measurement of attention
Time Frame
At the end of five days retreat
Title
NF-kB gene expression
Time Frame
At the end of five days retreat
Title
IL-1 gene expression
Time Frame
At the end of five days retreat
Title
IL-6 gene expression
Time Frame
At the end of five days retreat
Title
cRP expression
Description
c reactive protein
Time Frame
At the end of five days retreat
Title
Heart Rate Variability
Description
HRV
Time Frame
At the end of five days retreat
Title
Blood pressure
Time Frame
At the end of five days retreat
Title
Connectedness to Nature Scale
Time Frame
At the end of five days retreat
Title
GR gene expression
Time Frame
At the end of five days retreat
Title
RIPK2 gene expression
Time Frame
At the end of five days retreat
Title
TNF-α gene expression
Time Frame
At the end of five days retreat
Title
CCL5 gene expression
Time Frame
At the end of five days retreat
Title
IL-8 gene expression
Time Frame
At the end of five days retreat
Title
TERT gene expression
Time Frame
At the end of five days retreat
Title
TERC gene expression
Time Frame
At the end of five days retreat
Title
IL-1β protein expression
Time Frame
At the end of five days retreat
Title
IL-2 protein expression
Time Frame
At the end of five days retreat
Title
IL-4 protein expression
Time Frame
At the end of five days retreat
Title
IL-6 protein expression
Time Frame
At the end of five days retreat
Title
IL-8 protein expression
Time Frame
At the end of five days retreat
Title
IL-10 protein expression
Time Frame
At the end of five days retreat
Title
IL-12p70 protein expression
Time Frame
At the end of five days retreat
Title
IL-13 protein expression
Time Frame
At the end of five days retreat
Title
TNF-α protein expression
Time Frame
At the end of five days retreat
Title
IFN-γ protein expression
Time Frame
At the end of five days retreat

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesper Dahlgaard, PhD
Phone
+45 8755 2992
Email
jesd@via.dk
Facility Information:
Facility Name
VIA University College
City
Aarhus
ZIP/Postal Code
DK-8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesper Dahlgaard, PhD
Phone
+45 8755 2992
Email
jesd@via.dk
Facility Name
Nacadia, University of Copenhagen
City
Hoersholm
ZIP/Postal Code
2970
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorthe Djernis, Psychologist
Phone
+45 61688011
Email
ddj@ign.ku.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32691879
Citation
Kunzler AM, Helmreich I, Konig J, Chmitorz A, Wessa M, Binder H, Lieb K. Psychological interventions to foster resilience in healthcare students. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013684. doi: 10.1002/14651858.CD013684.
Results Reference
derived

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

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