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CompletedNCT04122534Updated Dec 31, 2020Results posted

Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample

An interventional study of Somatic Mindfulness Training in Occupational-based Secondary Trauma, sponsored by Montana State University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-31.

Sponsored by Montana State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Occupational-based Secondary Trauma

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03

In context

Compassion Fatigue

53 studies on the registry are indexed under Compassion Fatigue; 17 are open to participants now.

This study's enrollment of 48 is below the median of 60 across 39 interventional studies indexed under Compassion Fatigue.

Browse Compassion Fatigue studies →

Lead sponsor

Montana State University is the lead sponsor of 41 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Participant is under age 18.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Treatment Group

    Treatment groups receives the intervention training.

    Behavioral: Somatic Mindfulness Training

Interventions

  • BehavioralSomatic Mindfulness Training

    Educational and experiential training to reduce occupational-based secondary trauma.

06

What researchers measure

Primary outcomes

  1. Secondary Traumatic Stress Scale

    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.

    Time frame: This outcome measure will be assessed at week 15.

Secondary outcomes

  1. Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)

    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.

    Time frame: This outcome measure will be assessed at week 15.

07

Results

Posted Dec 31, 2020
Limitations and caveats
Outcome measures collected during COVID-19 pandemic.

Participant flow

Participant flow — Overall Study
MilestoneTreatment Group
Started48
Completed44
Not completed4
Withdrew: Lost to follow-up4

Outcome measures

PrimarySecondary Traumatic Stress Scale

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.

Time frame:
This outcome measure will be assessed at week 15.
Reported as:
Mean · units on a scale
Secondary Traumatic Stress Scale
units on a scaleTreatment Group
Secondary Traumatic Stress Scale35.23 ± 13.02
SecondaryPost Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)

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.

Time frame:
This outcome measure will be assessed at week 15.
Reported as:
Mean · units on a scale
Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)
units on a scaleTreatment Group
Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)28.47 ± 15.35

Adverse events

Collected over 15 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment Group0/48 (0%)0/48 (0%)0/48 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment Group
Mean21.67 ± 2.68
Sex: Female, Male
Sex: Female, Male(Participants)Treatment Group
Female33
Male15
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment Group
American Indian or Alaska Native1
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White41
More than one race4
Unknown or Not Reported1
Secondary Traumatic Stress Scale
Secondary Traumatic Stress Scale(units on a scale)Treatment Group
Mean35.71 ± 10.51
Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)(units on a scale)Treatment Group
Mean31.42 ± 15.86
08

Study locations

1 site
  • Montana State University
    Bozeman, Montana 59717, United States
09

References and documents

Study documents

  • Protocol, analysis plan and consent form · Aug 8, 2019

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04122534
Lead sponsor
Montana State University
Responsible party
Kelly Knight (Associate Professor, Montana State University) — Principal investigator
First posted
Oct 10, 2019
Start date
Sep 5, 2019
Primary completion
May 15, 2020
Completion
May 15, 2020
Results posted
Dec 31, 2020
Last update
Dec 31, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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