Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample

• Sponsor: Montana State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04122534
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.3
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Occupational-based Secondary Trauma	Behavioral: Somatic Mindfulness Training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample
• Actual Study Start Date: Sep 5, 2019
• Actual Primary Completion Date: May 15, 2020
• Actual Study Completion Date: May 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group Treatment groups receives the intervention training.	Behavioral: Somatic Mindfulness Training; Educational and experiential training to reduce occupational-based secondary trauma.

Outcome Measures

Primary Outcome Measures

1. Secondary Traumatic Stress Scale [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: 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:

• Participant is under age 18.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montana State University	Bozeman	Montana	United States	59717

Sponsors and Collaborators

• Montana State University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Aug 8, 2019

More Information

Publications

None provided.

• Responsible Party: Kelly Knight, Associate Professor, Montana State University
• ClinicalTrials.gov Identifier: NCT04122534
• Other Study ID Numbers: 1111
• First Posted: Oct 10, 2019
• Last Update Posted: Dec 31, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Compassion Fatigue

Study Results

Participant Flow

Arm/Group Title	Treatment Group
Arm/Group Description	Treatment groups receives the intervention training. Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma.
Period Title: Overall Study
STARTED	48
COMPLETED	44
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Treatment Group
Arm/Group Description	Treatment groups receives the intervention training. Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma.
Overall Participants	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.67 (2.68)
Sex: Female, Male (Count of Participants)
Female	33 68.8%
Male	15 31.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.1%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 2.1%
White	41 85.4%
More than one race	4 8.3%
Unknown or Not Reported	1 2.1%
Secondary Traumatic Stress Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	35.71 (10.51)
Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	31.42 (15.86)

Outcome Measures

1. Primary Outcome

Title	Secondary Traumatic Stress Scale
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Treatment groups receives the intervention training. Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma.
Measure Participants	26
Mean (Standard Deviation) [units on a scale]	35.23 (13.02)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Treatment groups receives the intervention training. Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma.
Measure Participants	43
Mean (Standard Deviation) [units on a scale]	28.47 (15.35)

Adverse Events

Time Frame	15 weeks
Arm/Group Title	Treatment Group
Arm/Group Description	Treatment groups receives the intervention training. Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma.
All Cause Mortality
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/48 (0%)
Serious Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/48 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/48 (0%)

Limitations/Caveats

Outcome measures collected during COVID-19 pandemic.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.