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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02867657
Other study ID # H-15010925
Secondary ID
Status Recruiting
Phase N/A
First received August 10, 2016
Last updated February 7, 2018
Start date June 2016
Est. completion date November 2018

Study information

Verified date February 2018
Source VIA University College
Contact Jesper Dahlgaard, PhD
Phone +45 8755 2992
Email jesd@via.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 .

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date November 2018
Est. primary completion date March 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Mindfulness
Five days MBSR curriculum with meditation and yoga

Locations

Country Name City State
Denmark VIA University College Aarhus
Denmark Nacadia, University of Copenhagen Hoersholm

Sponsors (3)

Lead Sponsor Collaborator
VIA University College University of Aarhus, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Stress Scale PSS At the end of five days retreat
Primary Self-compassion S-C-S Neff2 At the end of five days retreat
Secondary Five Facet Mindfulness Questionnaire At the end of five days retreat
Secondary Breath Counting Behavioral measurement of attention At the end of five days retreat
Secondary NF-kB gene expression At the end of five days retreat
Secondary IL-1 gene expression At the end of five days retreat
Secondary IL-6 gene expression At the end of five days retreat
Secondary cRP expression c reactive protein At the end of five days retreat
Secondary Heart Rate Variability HRV At the end of five days retreat
Secondary Blood pressure At the end of five days retreat
Secondary Connectedness to Nature Scale At the end of five days retreat
Secondary GR gene expression At the end of five days retreat
Secondary RIPK2 gene expression At the end of five days retreat
Secondary TNF-a gene expression At the end of five days retreat
Secondary CCL5 gene expression At the end of five days retreat
Secondary IL-8 gene expression At the end of five days retreat
Secondary TERT gene expression At the end of five days retreat
Secondary TERC gene expression At the end of five days retreat
Secondary IL-1ß protein expression At the end of five days retreat
Secondary IL-2 protein expression At the end of five days retreat
Secondary IL-4 protein expression At the end of five days retreat
Secondary IL-6 protein expression At the end of five days retreat
Secondary IL-8 protein expression At the end of five days retreat
Secondary IL-10 protein expression At the end of five days retreat
Secondary IL-12p70 protein expression At the end of five days retreat
Secondary IL-13 protein expression At the end of five days retreat
Secondary TNF-a protein expression At the end of five days retreat
Secondary IFN-? protein expression At the end of five days retreat
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