NCT02867657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 28, 2025

Status Verified

February 1, 2018

Enrollment Period

1.6 years

First QC Date

August 10, 2016

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Perceived Stress Scale

    PSS

    At the end of five days retreat

  • Self-compassion

    S-C-S Neff2

    At the end of five days retreat

Secondary Outcomes (26)

  • Five Facet Mindfulness Questionnaire

    At the end of five days retreat

  • Breath Counting

    At the end of five days retreat

  • NF-kB gene expression

    At the end of five days retreat

  • IL-1 gene expression

    At the end of five days retreat

  • IL-6 gene expression

    At the end of five days retreat

  • +21 more secondary outcomes

Study Arms (3)

Mindfulness in nature

EXPERIMENTAL

A five day mindfulness retreat in nature

Behavioral: Mindfulness

Mindfulness indoor

ACTIVE COMPARATOR

A five day mindfulness retreat indoor

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

Interventions

MindfulnessBEHAVIORAL

Five days MBSR curriculum with meditation and yoga

Also known as: Mindfulness Based Stress Reduction, MBSR
Mindfulness in natureMindfulness indoor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VIA University College

Aarhus, DK-8200, Denmark

Location

Nacadia, University of Copenhagen

Hoersholm, 2970, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress, PsychologicalInflammation

Interventions

MindfulnessMindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 16, 2016

Study Start

June 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 28, 2025

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations