NCT04676750

Brief Summary

Testing Mindfulness-based Stress Reduction (MBSR) in 60-65 year old senior employees.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

3 years

First QC Date

December 15, 2020

Last Update Submit

December 18, 2020

Conditions

Health Promotion and Stress Prevention

Outcome Measures

Primary Outcomes (1)

  • self-perceived stress

    questionnaire

    2 years

Secondary Outcomes (3)

  • Heart rate variability

    2 years

  • blood pressure

    2 years

  • weight

    2 years

Study Arms (2)

MBSR

EXPERIMENTAL

receives 8-week MBSR course

Behavioral: Mindfulness-Based Stress Reduction

control

NO INTERVENTION

receives intervention after experiment finishes

Interventions

Mindfulness-Based Stress ReductionBEHAVIORAL

yoga, meditation and psycho education

MBSR

Eligibility Criteria

Age60 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy

You may not qualify if:

  • psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dansk Center for Mindfulness

Aarhus, Brabrand, 8200, Denmark

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 21, 2020

Study Start

October 1, 2019

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)