Stress, PsychologicalNCT02867657
Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.
A study testing Mindfulness in people with Stress, Psychological and Inflammation, run by VIA University College at 2 sites in Denmark.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Inflammation, Stress, Physiological
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2016to Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bachelor student at a Danish University or University College
- A score of 16 or above on the Perceived Stress Scale (PSS)
Who cannot join
- Smoking
- Psychiatric diagnosis (depression, anxiety, adjustment disorder, PTSD, personality disorder, psychosis).
- Untreated ADHD, autism, abuse and risk of suicide
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
VIA University College
Aarhus, DK-8200
Nacadia, University of Copenhagen
Hoersholm, 2970
About this study
Official title: Enhancement of Presence, Compassion and Resilience Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.
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.
- Conditions
- Stress, Psychological, Inflammation, Stress, Physiological
- Being tested
- Mindfulness
- Medical subject headings
- Stress, Psychological, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Also called Mindfulness Based Stress Reduction, MBSR
Five days MBSR curriculum with meditation and yoga
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness in nature | Experimental | A five day mindfulness retreat in nature Receives: Behavioral: Mindfulness |
| Mindfulness indoor | Active comparator | A five day mindfulness retreat indoor Receives: Behavioral: Mindfulness |
| Wait list control | No intervention | A wait list control group, that 6 months later is offered a two-day mindfulness retreat in nature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
PSS
Measured: At the end of five days retreat
Self-compassion
S-C-S Neff2
Measured: At the end of five days retreat
Secondary outcomes (26)
Five Facet Mindfulness Questionnaire
Measured: At the end of five days retreat
Breath Counting
Behavioral measurement of attention
Measured: At the end of five days retreat
NF-kB gene expression
Measured: At the end of five days retreat
IL-1 gene expression
Measured: At the end of five days retreat
IL-6 gene expression
Measured: At the end of five days retreat
cRP expression
c reactive protein
Measured: At the end of five days retreat
Heart Rate Variability
HRV
Measured: At the end of five days retreat
Blood pressure
Measured: At the end of five days retreat
Connectedness to Nature Scale
Measured: At the end of five days retreat
GR gene expression
Measured: At the end of five days retreat
RIPK2 gene expression
Measured: At the end of five days retreat
TNF-α gene expression
Measured: At the end of five days retreat
CCL5 gene expression
Measured: At the end of five days retreat
IL-8 gene expression
Measured: At the end of five days retreat
TERT gene expression
Measured: At the end of five days retreat
TERC gene expression
Measured: At the end of five days retreat
IL-1β protein expression
Measured: At the end of five days retreat
IL-2 protein expression
Measured: At the end of five days retreat
IL-4 protein expression
Measured: At the end of five days retreat
IL-6 protein expression
Measured: At the end of five days retreat
IL-8 protein expression
Measured: At the end of five days retreat
IL-10 protein expression
Measured: At the end of five days retreat
IL-12p70 protein expression
Measured: At the end of five days retreat
IL-13 protein expression
Measured: At the end of five days retreat
TNF-α protein expression
Measured: At the end of five days retreat
IFN-γ protein expression
Measured: At the end of five days retreat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startJun 2016
- Primary completion1 Jan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIA University College
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University of Aarhus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867657
- Sponsor's protocol ID
- H-15010925
- Status last verified
- Feb 2018
- First submitted
- 10 Aug 2016
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32691879
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Presence, Compassion and Resilience Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.
- ClinicalTrials.gov ID
- NCT02867657
- Acronym / sponsor ID
- H-15010925
- Conditions
- Stress, Psychological, Inflammation, Stress, Physiological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- VIA University CollegeUniversity, hospital or other
- Collaborators
- University of Copenhagen, University of Aarhus
- Study start
- Jun 2016
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness in nature | Experimental | Behavioral: MindfulnessA five day mindfulness retreat in nature |
| Mindfulness indoor | Active comparator | Behavioral: MindfulnessA five day mindfulness retreat indoor |
| Wait list control | No intervention | –A wait list control group, that 6 months later is offered a two-day mindfulness retreat in nature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bachelor student at a Danish University or University College
- A score of 16 or above on the Perceived Stress Scale (PSS)
Key exclusion criteria (3 listed)
- Smoking
- Psychiatric diagnosis (depression, anxiety, adjustment disorder, PTSD, personality disorder, psychosis).
- Untreated ADHD, autism, abuse and risk of suicide
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 |
|---|---|---|
| MindfulnessAlso: Mindfulness Based Stress Reduction, MBSRFive days MBSR curriculum with meditation and yoga | Behavioural | Mindfulness in nature, Mindfulness indoor |
Primary outcome
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
26 secondary outcomes
Five Facet Mindfulness Questionnaire
Time frame: At the end of five days retreat
Breath Counting
Time frame: At the end of five days retreat
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
Heart Rate Variability
Time frame: At the end of five days retreat
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
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 28 Mar 2025.
- Derived from this study: PubMed 32691879Kunzler 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Stress, Psychological and Inflammation, run by VIA University College at 2 sites in Denmark.
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 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Perceived Stress Scale (time frame: At the end of five days retreat). The study lists 2 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 NCT02867657, which also lists 1 linked publication.
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 28 Mar 2025.