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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video-based intervention | Experimental | A brief video about coping with COVID-19 stress presented to the participants |
|
| vignette intervention | Experimental | A brief vignette about coping with COVID-19 stress presented to the participants |
|
| Control | No Intervention | Only assessment, no intervention arrm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A short video intervention | Other | Three minutes video of a veteran that shares his personal story |
|
| Measure | Description | Time Frame |
|---|---|---|
| Help Seeking Intention | Attitudes Toward Seeking Professional Help Scale Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions | Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuval Neria Neria, PhD | Columbia University and NYSPI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33734539 | Derived | Amsalem D, Lazarov A, Markowitz JC, Gorman D, Dixon LB, Neria Y. Increasing treatment-seeking intentions of US veterans in the Covid-19 era: A randomized controlled trial. Depress Anxiety. 2021 Jun;38(6):639-647. doi: 10.1002/da.23149. Epub 2021 Mar 18. |
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Data will be shared as needed with investigators, IRB etc. A plan will be determined in the short future
two months
Co-Is
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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."
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Control | Only assessment, no intervention arrm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Vignette Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Help Seeking Intention | Attitudes Toward Seeking Professional Help Scale Minimum value: 3 Maximum value: 12 Higher scores indicate higher help seeking intentions | Using the GEE method, all participants from this arm were analyzed at all time points. | Posted | Mean | Standard Deviation | units on a scale | Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30) |
|
Adverse event data were collected over the 30 days of the study period.
Our definitions of adverse event and serious adverse event do not differ from the definitions found on clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yuval Y. Neria | New York State Psychiatric Institute | 646-774-8092 | ny126@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2021 | Oct 12, 2021 | Prot_SAP_000.pdf |
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| A vignette intervention | Other | A written description of the content of the video |
|
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
| BG002 | Control | Only assessment, no intervention arrm |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Exposure to Military Trauma | Count of Participants | Participants |
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| Exposure to COVID-19 | Count of Participants | 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
| OG002 | Control | Only assessment, no intervention arrm |
|
|
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| 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 | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30) |
|
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| 0 |
| 86 |
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | 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 | 0 | 44 | 0 | 44 | 0 | 44 |
| EG002 | Control | Only assessment, no intervention arrm | 0 | 42 | 0 | 42 | 0 | 42 |
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| 14-Day Follow-Up |
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| 30-Day Follow-Up |
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