Trial Outcomes & Findings for First Responder Resiliency Program During COVID-19 (NCT NCT04536376)

NCT ID: NCT04536376

Last Updated: 2024-05-13

Results Overview

Perceived Stress Scale (PSS) is a 10-item Likert scale scoring system that measures global life stress by assessing the degree to which experiences are appraised as uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater perceived stress. The outcome was analyzed as change from baseline

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

4 weeks

Results posted on

2024-05-13

Participant Flow

Participant milestones

Participant milestones
Measure
Resilience Program
a 4 week program focused on improving resilience Resilience Program: Subjects receive program devices, and will be asked to wear during rest and sleep on a nightly basis along with active use during daytime. Notifications are sent daily, individualized approach developed and sent to participants to participate on.
Overall Study
STARTED
10
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

First Responder Resiliency Program During COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Resilience Program
n=10 Participants
a 4 week program focused on improving resilience Resilience Program: Subjects receive program devices, and will be asked to wear during rest and sleep on a nightly basis along with active use during daytime. Notifications are sent daily, individualized approach developed and sent to participants to participate on.
Age, Continuous
39.7 years
STANDARD_DEVIATION 5.6 • n=99 Participants
Sex: Female, Male
Female
4 Participants
n=99 Participants
Sex: Female, Male
Male
6 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
3 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
Race (NIH/OMB)
White
6 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Region of Enrollment
United States
10 participants
n=99 Participants

PRIMARY outcome

Timeframe: 4 weeks

Perceived Stress Scale (PSS) is a 10-item Likert scale scoring system that measures global life stress by assessing the degree to which experiences are appraised as uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater perceived stress. The outcome was analyzed as change from baseline

Outcome measures

Outcome measures
Measure
Resilience Program
n=10 Participants
a 4 week program focused on improving resilience Resilience Program: Subjects receive program devices, and will be asked to wear during rest and sleep on a nightly basis along with active use during daytime. Notifications are sent daily, individualized approach developed and sent to participants to participate on.
Perceived Stress Scale
-3.2 units on a scale
Standard Deviation 3.9

Adverse Events

Resilience Program

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. Ivana T. Croghan

Mayo Clinic

Phone: 507-284-2511

Results disclosure agreements

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