- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04122534
Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample
December 7, 2020 updated by: Kelly Knight, Montana State University
This pilot study evaluates a somatic mindfulness training.
Reductions in mental and physical health correlates of secondary trauma are assessed using a pretest-posttest design.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
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
-
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Montana
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Bozeman, Montana, United States, 59717
- Montana State University
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-
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 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant must be either employed or volunteering as a victim service provider, or enrolled at Montana State University as an undergraduate student.
Exclusion Criteria:
- Participant is under age 18.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Treatment groups receives the intervention training.
|
Educational and experiential training to reduce occupational-based secondary trauma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Traumatic Stress Scale
Time Frame: This outcome measure will be assessed at week 15.
|
Measures occupational-based secondary traumatic stress using a total scale range of 17(min) to 85 (max).
Scores above 37 indicate moderate or higher secondary traumatic stress.
|
This outcome measure will be assessed at week 15.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: This outcome measure will be assessed at week 15.
|
Measures symptoms of post-traumatic stress disorder using a total scale range of 0 (min) to 80 (max), with a score of 33 or higher indicating that participants maybe suffering from Post Traumatic Stress Disorder.
|
This outcome measure will be assessed at week 15.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 5, 2019
Primary Completion (Actual)
May 15, 2020
Study Completion (Actual)
May 15, 2020
Study Registration Dates
First Submitted
September 28, 2019
First Submitted That Met QC Criteria
October 9, 2019
First Posted (Actual)
October 10, 2019
Study Record Updates
Last Update Posted (Actual)
December 31, 2020
Last Update Submitted That Met QC Criteria
December 7, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1111
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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