- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02194478
Stress Reduction for Busy Professionals
August 31, 2016 updated by: Allina Health System
Pilot Study of a Brief Mind/Body Meditation Intervention for Allina Health Employees
This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week mind-body/meditation intervention on self-reported quality of life in individuals employed by Allina Health.
Outcomes will include validated questionnaires for depressive symptomology, perceived stress, anxiety, healthy lifestyle, quality of life as well as biological outcomes of salivary cortisol for a sub-sample of employees.
Study Overview
Study Type
Interventional
Enrollment (Actual)
101
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
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55407
- Allina Health
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women aged 18 to 65 years
- Actively-working healthcare professional employed by Allina Health.
Exclusion Criteria:
- Previous participation in an Allina Health stress reduction program
- Non-English speaking
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 8 Week Meditation
Allina Health employees undergoing 8 week meditation intervention
|
30 minute, 8 week meditation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived stress change from baseline at week 8
Time Frame: Baseline, Week 8
|
Perceived stress will be measured through the Perceived Stress Scale at baseline and week 8.
|
Baseline, Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary Cortisol Levels Change from baseline at week 8
Time Frame: Baseline, Week 8
|
Salivary samples will be obtained at baseline and week 8.
|
Baseline, Week 8
|
Lifestyle Profile change from baseline at week 8
Time Frame: Baseline, Week 8
|
The Lifestyle Profile questionnaire measures self actualization, health responsibility, exercise, nutrition, interpersonal support, and stress management.
It will be administered at baseline and week 8.
|
Baseline, Week 8
|
Work productivity and activity impairment change from baseline at week 8
Time Frame: Baseline, Week 8
|
Work productivity and activity impairment will be measured through the WPAI:GH and will be administered at baseline and week 8.
|
Baseline, Week 8
|
Promis-29 score change from baseline at week 8
Time Frame: Baseline, Week 8
|
The Promis-29 is a 29 item questionnaire measuring physical function, fatigue, pain, depression, anxiety, and social role participation.
The questionnaire will be administered at baseline and week 8.
|
Baseline, Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffery Dusek, PhD, Allina Health
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
October 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
July 16, 2014
First Submitted That Met QC Criteria
July 16, 2014
First Posted (Estimate)
July 18, 2014
Study Record Updates
Last Update Posted (Estimate)
September 1, 2016
Last Update Submitted That Met QC Criteria
August 31, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- S091301
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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