- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04676750
MBSR for Work Active Seniors (MBSR6065)
December 18, 2020 updated by: University of Aarhus
Mindfulness-baseret Forebyggelse og Sundhedsfremme i Den Sidste Del af Arbejdslivet
Testing Mindfulness-based Stress Reduction (MBSR) in 60-65 year old senior employees.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Outcome measures: HRV, blood pressure, weight, structural and functional brain scans, questionnaire
Study Type
Interventional
Enrollment (Anticipated)
192
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Brabrand
-
Aarhus, Brabrand, Denmark, 8200
- Dansk Center for Mindfulness
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy
Exclusion Criteria:
- psychosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MBSR
receives 8-week MBSR course
|
yoga, meditation and psycho education
|
No Intervention: control
receives intervention after experiment finishes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self-perceived stress
Time Frame: 2 years
|
questionnaire
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weight
Time Frame: 2 years
|
2 years
|
Heart rate variability
Time Frame: 2 years
|
2 years
|
blood pressure
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
December 15, 2020
First Submitted That Met QC Criteria
December 18, 2020
First Posted (Actual)
December 21, 2020
Study Record Updates
Last Update Posted (Actual)
December 21, 2020
Last Update Submitted That Met QC Criteria
December 18, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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