Trial Outcomes & Findings for Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample (NCT NCT04122534)

NCT ID: NCT04122534

Last Updated: 2020-12-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 48 participants
• Primary outcome timeframe: This outcome measure will be assessed at week 15.
• Results posted on: 2020-12-31

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Treatment Group Treatment groups receives the intervention training. Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma.
Overall Study Lost to Follow-up	4

Baseline Characteristics

Missing data.

Baseline characteristics by cohort

Measure	Treatment Group n=48 Participants Treatment groups receives the intervention training. Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma.
Age, Continuous	21.67 years STANDARD_DEVIATION 2.68 • n=48 Participants
Sex: Female, Male Female	33 Participants n=48 Participants
Sex: Female, Male Male	15 Participants n=48 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=48 Participants
Race (NIH/OMB) Asian	0 Participants n=48 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=48 Participants
Race (NIH/OMB) Black or African American	1 Participants n=48 Participants
Race (NIH/OMB) White	41 Participants n=48 Participants
Race (NIH/OMB) More than one race	4 Participants n=48 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=48 Participants
Secondary Traumatic Stress Scale	35.71 units on a scale STANDARD_DEVIATION 10.51 • n=35 Participants • Missing data.
Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)	31.42 units on a scale STANDARD_DEVIATION 15.86 • n=48 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment Group n=26 Participants Treatment groups receives the intervention training. Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma.
Secondary Traumatic Stress Scale	35.23 units on a scale Standard Deviation 13.02

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment Group n=43 Participants Treatment groups receives the intervention training. Somatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma.
Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)	28.47 units on a scale Standard Deviation 15.35

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kelly E. Knight

Montana State University

Phone: 303-819-6997

Email: kelly.knight3@montana.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place