MBSR for Work Active Seniors | NCT04676750

Studies
MBSR for Work Active Seniors

NCT04676750

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Dec 21, 2020Actual

Enrollment

192Estimated

Phase

Not Applicable

Conditions

Health Promotion and Stress Prevention

Interventions

Mindfulness-Based Stress Reduction

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Oct 1, 2022Estimated

First Submitted Date

Dec 15, 2020

First Submission Date that Met QC Criteria

Dec 18, 2020

First Posted Date

Dec 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2020

Last Update Posted Date

Dec 21, 2020Actual

Name	Class
VU University of Amsterdam	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

192Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MBSR	Experimental	receives 8-week MBSR course	Behavioral: Mindfulness-Based Stress Reduction
control	No Intervention	receives intervention after experiment finishes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness-Based Stress Reduction	Behavioral	yoga, meditation and psycho education	MBSR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
self-perceived stress	questionnaire	2 years

Secondary Outcomes

Measure	Description	Time Frame
Heart rate variability		2 years
blood pressure		2 years
weight

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy

Exclusion Criteria:

psychosis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dansk Center for Mindfulness		Aarhus	Brabrand	8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000099024	Mindfulness-Based Stress Reduction

Ancestor Terms

ID	Term
D064866	Mindfulness
D015928	Cognitive Behavioral Therapy
D001521	Behavior Therapy
D011613	Psychotherapy

Browse Leaves

Not provided

Browse Branches

Not provided