Health Promotion and Stress PreventionMBSR6065NCT04676750
MBSR for Work Active Seniors
A study testing Mindfulness-Based Stress Reduction in people with Health Promotion and Stress Prevention, run by University of Aarhus at 1 site in Denmark.
Trial summary
Testing Mindfulness-based Stress Reduction (MBSR) in 60-65 year old senior employees. Read more about this study
- Who is it for?
- Ages 60 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Promotion and Stress Prevention
- What is being tested?
- Mindfulness-Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2019to 1 Oct 2022
- 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 60 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
Who cannot join
- psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness-baseret Forebyggelse og Sundhedsfremme i Den Sidste Del af Arbejdslivet
Testing Mindfulness-based Stress Reduction (MBSR) in 60-65 year old senior employees.
Read the detailed description
Outcome measures: HRV, blood pressure, weight, structural and functional brain scans, questionnaire
- Conditions
- Health Promotion and Stress Prevention
- Being tested
- Mindfulness-Based Stress Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
yoga, meditation and psycho education
| Study group | Role | What they receive |
|---|---|---|
| MBSR | Experimental | receives 8-week MBSR course Receives: Behavioral: Mindfulness-Based Stress Reduction |
| control | No intervention | receives intervention after experiment finishes |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-perceived stress
questionnaire
Measured: 2 years
Secondary outcomes (3)
Heart rate variability
Measured: 2 years
blood pressure
Measured: 2 years
weight
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Oct 2019
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Promotion and Stress PreventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676750
- Sponsor's protocol ID
- 10
- Acronym
- MBSR6065
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-baseret Forebyggelse og Sundhedsfremme i Den Sidste Del af Arbejdslivet
- ClinicalTrials.gov ID
- NCT04676750
- Acronym / sponsor ID
- MBSR6065 / 10
- Conditions
- Health Promotion and Stress Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 21 Dec 2020 (actual)
- 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.
Testing Mindfulness-based Stress Reduction (MBSR) in 60-65 year old senior employees.
Detailed description
Outcome measures: HRV, blood pressure, weight, structural and functional brain scans, questionnaire
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR | Experimental | Behavioral: Mindfulness-Based Stress Reductionreceives 8-week MBSR course |
| control | No intervention | –receives intervention after experiment finishes |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (1 listed)
- psychosis
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 |
|---|---|---|
| Mindfulness-Based Stress Reductionyoga, meditation and psycho education | Behavioural | MBSR |
Primary outcome
self-perceived stress
Time frame: 2 years
questionnaire
3 secondary outcomes
Heart rate variability
Time frame: 2 years
blood pressure
Time frame: 2 years
weight
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction in people with Health Promotion and Stress Prevention, run by University of Aarhus at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
self-perceived stress (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2020.