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Addressing COVID-19 Mental Health Problems Among US Veterans

Addressing COVID-19 Mental Health Problems Among US Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04484207
Enrollment
172
Registered
2020-07-23
Start date
2020-07-06
Completion date
2020-10-26
Last updated
2021-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brief Video-based Intervention, Non Intervention Control Arm, Vignette Based Intervention

Brief summary

Coronavirus disease 2019 (COVID-19) has widely and rapidly spread around the world, overwhelming intensive care units and health care capacity. While the physical risk (e.g. pneumonia, respiratory breakdown) is getting the most scientific and clinical attention, this outbreak also has significant mental health risks and extreme psychological fear-related responses. Among the general population, there are high-risk groups as elderly people, disabled individuals and people with previous exposure to trauma (e.g., people with military experience). Veterans are among the subgroups who are high risk for PTSD and other mental health problem. The overarching goal of this study is to examine the efficacy of an online, largescale, brief video-based intervention in reducing fear and stress and improving help seeking behavior in relate to COVID-19.

Detailed description

Coronavirus disease 2019 (COVID-19) has widely and rapidly spread around the world, overwhelming intensive care units and health care capacity, leading the World Health Organization (WHO) to declare a pandemic. According to the official website of the WHO1, more than 3 million people have been confirmed to have a COVID-19 infection, and over than 200,000 deaths have resulted from COVID-19 in almost every area or territories around the world. To effectively cope with the COVID-19 outbreak, various governments have implemented rapid and comprehensive public health emergency interventions that include social restrictions and quarantines, which is the separation and restriction of movement of people who might have been exposed to the virus. Non-essential workers were required to stay at home and the shutdown of non-essential businesses are among the restrictions that influence the lives of millions across the globe. While the physical risk (e.g. pneumonia, respiratory breakdown) is getting the most scientific and clinical attention, this outbreak also has significant mental health risks and extreme psychological fear-related responses. The outbreak of COVID-19 caused public panic and mental health stress. The rapidly changing information on COVID-19 and the increasing number of confirmed cases and death have elicited fear and anxiety about becoming infected. Isolated at home, people consume information that might be unreliable and unverified for many hours every day. The widespread use of social media and the extensive array (or sources) of information can increase confusion and worries which in turn increases fear and anxiety. Moreover, indirect exposure to 24-hours of television news and social media has a wide range of psychopathological consequences, of which Posttraumatic Stress Disorder (PTSD) symptoms are the most common. A recent study conducted in China one month into the outbreak examined the prevalence of mental health problems in COVID-19 era and found a high rate of depression (48.3%), anxiety (22.6%) and a combination of depression and anxiety (19.4%) among 4,872 people. Furthermore, people with increased social media exposure were almost twice as likely to have depression and anxiety than people with less social media exposure. To date, more than 3 billion people are being asked to stay at home, which may lead to increased exposure to social media, likely resulting in widespread mental health problems among isolated individuals around the globe. Given the magnitude of the COVID-19 outbreak, its risk to physical and mental health,and the unique nature requiring to stay isolated, sheltered, at hospitals, or at home, an effective and timely response is essential to address the psychosocial needs associated with the ongoing exposure to social media, disease, death, and distress. Among the general population, there are high-risk groups as elderly people, disabled individuals and people with previous exposure to trauma (e.g., people with military experience). Veterans are among the subgroups who are high risk for PTSD and other mental health problem. Furthermore, many veterans are reluctant to seek help, despite enduring symptoms, they avoid mental health care, or may wait years to decades before they seek help. Among reasons to avoid seeking help, patients report mistrust in mental health providers, being seen as weak or stereotyped as dangerous/violent/crazy, and a belief that they are responsible for having mental health problems. Applying strategies to reduce self-stigma and improve help seeking behavior among veterans may ameliorate impaired functioning and reduce risks for long-term psychiatric illness. Thornicroft showed that social contact is the most effective type of intervention to improve helpseeking behavior and stigma-related attitudes. Social contact involves interpersonal contact with a member of the group; While both direct, in-person social contact and indirect, video-based social contact have effectively improved attitudes toward mental illness, the latter can be implemented on a larger scale. Corrigan and colleagues11 identified the most important ingredients of contact-based programs: an empowered presenter with lived experience who attains his/her goals (e.g., I was able to fight the COVID-19). The overarching goal of this study is to examine the efficacy of an online, large-scale, brief video-based intervention in reducing fear and stress and improving help seeking behavior in relate to COVID-19.

Interventions

OTHERA short video intervention

Three minutes video of a veteran that shares his personal story

OTHERA vignette intervention

A written description of the content of the video

Sponsors

Research Foundation for Mental Hygiene, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* English speakers, veterans (military experience) aged 18-80, US residents

Exclusion criteria

* non-English speakers, age less than 18 or more than 80

Design outcomes

Primary

MeasureTime frameDescription
Help Seeking IntentionAssessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)Attitudes Toward Seeking Professional Help Scale Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions

Secondary

MeasureTime frameDescription
Help Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSDAssessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)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

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
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
86
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
44
Control
Only assessment, no intervention arrm
42
Total172

Baseline characteristics

CharacteristicVideo-based InterventionVignette InterventionControlTotal
Age, Continuous48.2 years
STANDARD_DEVIATION 14.3
45.4 years
STANDARD_DEVIATION 13.3
47.3 years
STANDARD_DEVIATION 15.6
47.2 years
STANDARD_DEVIATION 14.3
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants5 Participants3 Participants15 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
79 Participants39 Participants39 Participants157 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Exposure to COVID-1926 Participants17 Participants17 Participants60 Participants
Exposure to Military Trauma23 Participants16 Participants10 Participants49 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants2 Participants4 Participants
Race (NIH/OMB)
Black or African American
12 Participants2 Participants9 Participants23 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants3 Participants3 Participants12 Participants
Race (NIH/OMB)
White
64 Participants39 Participants28 Participants131 Participants
Region of Enrollment
United States
86 participants44 participants42 participants172 participants
Sex: Female, Male
Female
26 Participants14 Participants14 Participants54 Participants
Sex: Female, Male
Male
60 Participants30 Participants28 Participants118 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 860 / 440 / 42
other
Total, other adverse events
0 / 860 / 440 / 42
serious
Total, serious adverse events
0 / 860 / 440 / 42

Outcome results

Primary

Help Seeking Intention

Attitudes Toward Seeking Professional Help Scale Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Video-based InterventionHelp Seeking IntentionBaseline7.4 units on a scaleStandard Deviation 2.7
Video-based InterventionHelp Seeking IntentionPost-Intervention8.2 units on a scaleStandard Deviation 2.5
Video-based InterventionHelp Seeking Intention14-Day Follow-Up8.7 units on a scaleStandard Deviation 1.1
Video-based InterventionHelp Seeking Intention30-Day Follow-Up8.6 units on a scaleStandard Deviation 1.2
Vignette InterventionHelp Seeking Intention30-Day Follow-Up8.6 units on a scaleStandard Deviation 1.1
Vignette InterventionHelp Seeking IntentionBaseline7.9 units on a scaleStandard Deviation 2.3
Vignette InterventionHelp Seeking Intention14-Day Follow-Up8.7 units on a scaleStandard Deviation 1.3
Vignette InterventionHelp Seeking IntentionPost-Intervention8.1 units on a scaleStandard Deviation 2.2
ControlHelp Seeking Intention30-Day Follow-Up8.4 units on a scaleStandard Deviation 1.3
ControlHelp Seeking IntentionPost-Intervention7.6 units on a scaleStandard Deviation 2.5
ControlHelp Seeking Intention14-Day Follow-Up8.2 units on a scaleStandard Deviation 1.7
ControlHelp Seeking IntentionBaseline7.3 units on a scaleStandard Deviation 2.5
p-value: 0.031GEE
Secondary

Help Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD

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

Time frame: 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.

ArmMeasureGroupValue (MEAN)
Video-based InterventionHelp Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSDPost-Intervention8.4 score on a scale
Video-based InterventionHelp Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSDBaseline7.6 score on a scale
Video-based InterventionHelp Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD14-Day Follow-Up8.9 score on a scale
Video-based InterventionHelp Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD30-Day Follow-Up8.6 score on a scale
Vignette InterventionHelp Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD30-Day Follow-Up8.3 score on a scale
Vignette InterventionHelp Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD14-Day Follow-Up8.5 score on a scale
Vignette InterventionHelp Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSDBaseline8.1 score on a scale
Vignette InterventionHelp Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSDPost-Intervention8.1 score on a scale
ControlHelp Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSDBaseline7.7 score on a scale
ControlHelp Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSDPost-Intervention8.0 score on a scale
ControlHelp Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD14-Day Follow-Up8.2 score on a scale
ControlHelp Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD30-Day Follow-Up8.2 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026