Trial Outcomes & Findings for The COVID-19 and Healthcare Workers: An Active Intervention (NCT NCT04497415)
NCT ID: NCT04497415
Last Updated: 2022-01-14
Results Overview
Measured with the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPH) - total scores range from 3 to 12, with higher scores indicating greater treatment-seeking intentions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
350 participants
Primary outcome timeframe
Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)
Results posted on
2022-01-14
Participant Flow
Participant milestones
| Measure |
Video-based Intervention
A brief video about coping with COVID-19 stress presented to the participants
Video-Based intervention: Three minutes video of a nurse that shares her personal story
|
Assessment Only
Control
|
|---|---|---|
|
Overall Study
STARTED
|
229
|
121
|
|
Overall Study
Post-intervention Assessment (Day 1)
|
229
|
121
|
|
Overall Study
First Follow-up Assessment (Day 14)
|
195
|
102
|
|
Overall Study
COMPLETED
|
186
|
94
|
|
Overall Study
NOT COMPLETED
|
43
|
27
|
Reasons for withdrawal
| Measure |
Video-based Intervention
A brief video about coping with COVID-19 stress presented to the participants
Video-Based intervention: Three minutes video of a nurse that shares her personal story
|
Assessment Only
Control
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
43
|
27
|
Baseline Characteristics
The COVID-19 and Healthcare Workers: An Active Intervention
Baseline characteristics by cohort
| Measure |
Video-based Intervention
n=229 Participants
A brief video about coping with COVID-19 stress presented to the participants
Video-Based intervention: Three minutes video of a nurse that shares her personal story
|
Assessment Only
n=121 Participants
Control
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
33.8 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
201 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
170 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
229 participants
n=5 Participants
|
121 participants
n=7 Participants
|
350 participants
n=5 Participants
|
|
Occupation
Nurse
|
156 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Occupation
Physician
|
37 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Occupation
EMT
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Occupation
Other
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Exposure to COVID-19
|
105 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)Population: Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).
Measured with the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPH) - total scores range from 3 to 12, with higher scores indicating greater treatment-seeking intentions
Outcome measures
| Measure |
Video-based Intervention
n=229 Participants
A brief video about coping with COVID-19 stress presented to the participants
Video-Based intervention: Three minutes video of a nurse that shares her personal story
|
Assessment Only
n=121 Participants
Control
|
|---|---|---|
|
Help-seeking Behavior
Baseline
|
8.2 units on a scale
Interval 7.9 to 8.5
|
8.5 units on a scale
Interval 8.1 to 8.9
|
|
Help-seeking Behavior
Post-intervention
|
9.3 units on a scale
Interval 9.0 to 9.6
|
8.7 units on a scale
Interval 8.2 to 9.1
|
|
Help-seeking Behavior
First follow-up (day 14)
|
9.7 units on a scale
Interval 9.4 to 10.0
|
9.3 units on a scale
Interval 8.9 to 9.7
|
|
Help-seeking Behavior
Second follow-up (day 30)
|
9.4 units on a scale
Interval 9.1 to 9.7
|
9.1 units on a scale
Interval 8.8 to 9.5
|
PRIMARY outcome
Timeframe: Assessed at baseline, 14-day follow-up, and 30-day follow-upPopulation: Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).
Measured with the GAD-7 scale - total scores range from 0 to 21, with higher scores indicating greater self-reported anxiety
Outcome measures
| Measure |
Video-based Intervention
n=229 Participants
A brief video about coping with COVID-19 stress presented to the participants
Video-Based intervention: Three minutes video of a nurse that shares her personal story
|
Assessment Only
n=121 Participants
Control
|
|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7)
Baseline (day 1)
|
7.6 units on a scale
Standard Deviation 5.9
|
6.7 units on a scale
Standard Deviation 6.1
|
|
Generalized Anxiety Disorder-7 (GAD-7)
First follow-up (day 14)
|
6.9 units on a scale
Standard Deviation 6.0
|
5.9 units on a scale
Standard Deviation 5.2
|
|
Generalized Anxiety Disorder-7 (GAD-7)
Second follow-up (day 30)
|
6.5 units on a scale
Standard Deviation 5.7
|
5.4 units on a scale
Standard Deviation 5.3
|
PRIMARY outcome
Timeframe: Assessed at baseline, 14-day follow-up, and 30-day follow-upPopulation: Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).
Measured with PHQ-9 - total scores range from 0 to 27; higher scores indicate greater self-reported depression
Outcome measures
| Measure |
Video-based Intervention
n=229 Participants
A brief video about coping with COVID-19 stress presented to the participants
Video-Based intervention: Three minutes video of a nurse that shares her personal story
|
Assessment Only
n=121 Participants
Control
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Baseline (day 1)
|
7.9 units on a scale
Standard Deviation 6.6
|
6.6 units on a scale
Standard Deviation 5.6
|
|
Patient Health Questionnaire-9 (PHQ-9)
First follow-up (day 14)
|
7.4 units on a scale
Standard Deviation 6.7
|
6.0 units on a scale
Standard Deviation 5.7
|
|
Patient Health Questionnaire-9 (PHQ-9)
Second follow-up (day 30)
|
7.0 units on a scale
Standard Deviation 6.2
|
5.4 units on a scale
Standard Deviation 5.7
|
PRIMARY outcome
Timeframe: Assessed at baseline, 14-day follow-up, and 30-day follow-upPopulation: Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).
Measured with the PC-PTSD for DSM-5 - total scores range from 0 to 5, with higher scores indicating greater self-reported PTSD symptoms
Outcome measures
| Measure |
Video-based Intervention
n=229 Participants
A brief video about coping with COVID-19 stress presented to the participants
Video-Based intervention: Three minutes video of a nurse that shares her personal story
|
Assessment Only
n=121 Participants
Control
|
|---|---|---|
|
Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen
Baseline (day 1)
|
1.9 units on a scale
Standard Deviation 1.6
|
1.8 units on a scale
Standard Deviation 1.7
|
|
Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen
First follow-up (day 14)
|
1.8 units on a scale
Standard Deviation 1.6
|
1.2 units on a scale
Standard Deviation 1.5
|
|
Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen
Second follow-up (day 30)
|
1.7 units on a scale
Standard Deviation 1.7
|
1.4 units on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Assessed at baseline, 14-day follow-up, and 30-day follow-upPopulation: Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).
Measured with the MIES - scores range from 9 to 36, with higher scores indicating greater moral injury
Outcome measures
| Measure |
Video-based Intervention
n=229 Participants
A brief video about coping with COVID-19 stress presented to the participants
Video-Based intervention: Three minutes video of a nurse that shares her personal story
|
Assessment Only
n=121 Participants
Control
|
|---|---|---|
|
Moral Injury Events Scale (MIES)
Baseline (day 1)
|
18.1 units on a scale
Standard Deviation 6.4
|
17.1 units on a scale
Standard Deviation 6.6
|
|
Moral Injury Events Scale (MIES)
First follow-up (day 14)
|
18.1 units on a scale
Standard Deviation 6.8
|
16.5 units on a scale
Standard Deviation 6.3
|
|
Moral Injury Events Scale (MIES)
Second follow-up (day 30)
|
17.5 units on a scale
Standard Deviation 6.7
|
16.5 units on a scale
Standard Deviation 6.9
|
Adverse Events
Video-based Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Assessment Only
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place