Trial Outcomes & Findings for Addressing COVID-19 Mental Health Problems Among US Veterans (NCT NCT04484207)
NCT ID: NCT04484207
Last Updated: 2021-10-28
Results Overview
Attitudes Toward Seeking Professional Help Scale Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
172 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
2021-10-28
Participant Flow
First, we excluded duplicate submissions, assessments completed in less than minimum expected time, locations (coordinates) outside of the United States, and suspicious IP addresses. Second, we used an open-ended question format requiring the participant's age as a validity question and allowed only a two-digit number as a valid answer and compared responses with age data MTurk provided. Third, we added a question about military trauma with an option of "I did not serve in the military."
Participant milestones
| Measure |
Video-based Intervention
A brief video about coping with COVID-19 stress presented to the participants
A short video intervention: Three minute video of a veteran who shares his personal story
|
Vignette Intervention
A brief vignette about coping with COVID-19 stress presented to the participants
A vignette intervention: A written description of the content of the video
|
Control
Only assessment, no intervention arrm
|
|---|---|---|---|
|
Overall Study
STARTED
|
86
|
44
|
42
|
|
Overall Study
14-Day Follow-Up
|
69
|
40
|
33
|
|
Overall Study
30-Day Follow-Up
|
65
|
34
|
31
|
|
Overall Study
COMPLETED
|
65
|
34
|
31
|
|
Overall Study
NOT COMPLETED
|
21
|
10
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Addressing COVID-19 Mental Health Problems Among US Veterans
Baseline characteristics by cohort
| Measure |
Video-based Intervention
n=86 Participants
A brief video about coping with COVID-19 stress presented to the participants
A short video intervention: Three minute video of a veteran who shares his personal story
|
Vignette Intervention
n=44 Participants
A brief vignette about coping with COVID-19 stress presented to the participants
A vignette intervention: A written description of the content of the video
|
Control
n=42 Participants
Only assessment, no intervention arrm
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.2 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 14.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=5 Participants
|
44 participants
n=7 Participants
|
42 participants
n=5 Participants
|
172 participants
n=4 Participants
|
|
Exposure to Military Trauma
|
23 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Exposure to COVID-19
|
26 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
60 Participants
n=4 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: Using the GEE method, all participants from this arm were analyzed at all time points.
Attitudes Toward Seeking Professional Help Scale Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions
Outcome measures
| Measure |
Video-based Intervention
n=86 Participants
A brief video about coping with COVID-19 stress presented to the participants
A short video intervention: Three minute video of a veteran who shares his personal story
|
Vignette Intervention
n=44 Participants
A brief vignette about coping with COVID-19 stress presented to the participants
A vignette intervention: A written description of the content of the video
|
Control
n=42 Participants
Only assessment, no intervention arrm
|
|---|---|---|---|
|
Help Seeking Intention
Baseline
|
7.4 units on a scale
Standard Deviation 2.7
|
7.9 units on a scale
Standard Deviation 2.3
|
7.3 units on a scale
Standard Deviation 2.5
|
|
Help Seeking Intention
Post-Intervention
|
8.2 units on a scale
Standard Deviation 2.5
|
8.1 units on a scale
Standard Deviation 2.2
|
7.6 units on a scale
Standard Deviation 2.5
|
|
Help Seeking Intention
14-Day Follow-Up
|
8.7 units on a scale
Standard Deviation 1.1
|
8.7 units on a scale
Standard Deviation 1.3
|
8.2 units on a scale
Standard Deviation 1.7
|
|
Help Seeking Intention
30-Day Follow-Up
|
8.6 units on a scale
Standard Deviation 1.2
|
8.6 units on a scale
Standard Deviation 1.1
|
8.4 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)Population: In order to measure this outcome, only veterans from the original sample who reported symptoms of anxiety, depression, or PTSD were analyzed. Using the GEE method, all participants from this arm were analyzed at all time points.
Attitudes Toward Seeking Professional Help Scale among veterans who reported anxiety, depression, or PTSD Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions
Outcome measures
| Measure |
Video-based Intervention
n=54 Participants
A brief video about coping with COVID-19 stress presented to the participants
A short video intervention: Three minute video of a veteran who shares his personal story
|
Vignette Intervention
n=30 Participants
A brief vignette about coping with COVID-19 stress presented to the participants
A vignette intervention: A written description of the content of the video
|
Control
n=34 Participants
Only assessment, no intervention arrm
|
|---|---|---|---|
|
Help Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD
Baseline
|
7.6 score on a scale
Interval 6.9 to 8.3
|
8.1 score on a scale
Interval 7.4 to 8.8
|
7.7 score on a scale
Interval 6.9 to 8.5
|
|
Help Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD
Post-Intervention
|
8.4 score on a scale
Interval 7.9 to 9.1
|
8.1 score on a scale
Interval 7.3 to 8.9
|
8.0 score on a scale
Interval 7.3 to 8.8
|
|
Help Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD
14-Day Follow-Up
|
8.9 score on a scale
Interval 8.3 to 9.6
|
8.5 score on a scale
Interval 8.1 to 9.0
|
8.2 score on a scale
Interval 7.5 to 8.9
|
|
Help Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD
30-Day Follow-Up
|
8.6 score on a scale
Interval 7.9 to 9.3
|
8.3 score on a scale
Interval 7.9 to 8.8
|
8.2 score on a scale
Interval 7.7 to 8.8
|
Adverse Events
Video-based Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vignette Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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