Addressing COVID-19 Mental Health Problems Among US Veterans
Phase: NA
Conditions: Brief Video-based Intervention, Vignette Based Intervention, Non Intervention Control Arm
Sponsor: Research Foundation for Mental Hygiene, Inc.

Cover Page for ClinicalTrials.gov 
Official Title of the Study: 
 
The COVID-19 Pandemic and Veterans: An Active Intervention 
NCT Number:  
 
NCT04484207 
Principal Investigator: 
Yuval Neria, PhD  
Yuval.Neria@nyspi.columbia.edu  
646-774-8041 
Date of Document: 
 
October 6, 2021 
 
 

Statistical Analysis Plan 
 
Data will be analyzed using SPSS 26.0. We will use Pearson’s Chi-square and one-way 
ANOVA to compare demographic variables, baseline psychopathological characteristics, and 
baseline ATSPPH-SF scores of the three groups. We will use Independent t-tests to compare 
baseline psychopathological characteristics (continuous variables), and Chi-square tests to 
compare the severity of each psychopathology (ordinal variables) of participants who do and do 
not report Covid-19 exposure. All statistical tests will be 2-sided, using α<0.05.  
Intervention effects will be tested using the generalized estimating equations (GEE) 
approach, as recommended for randomized controlled trials. The GEE approach accounts for 
correlated repeated-measures analysis and accommodates missing data via estimated marginal 
means relying on the entire sample. Thus, this analytic strategy includes data from all 
randomized participants who provide at least one data point. To represent within-subject 
dependencies in the models, we will specify an unstructured correlation matrix. We will first 
apply a full factorial model across the four time points (baseline and post-intervention, 14 and 
30-day follow-ups) for treatment-seeking intentions, and three time points (baseline, 14- and 30-
day follow-ups) for clinical symptoms. Time-by-group interaction terms will be used to test the 
intervention effect hypothesis of greater treatment-seeking in the video group. For significant 
differences, post hoc tests will be used to compare each group pair. Effect sizes will be reported 
using Cohen’s d when appropriate. 

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Protocol Title:
The COVID-19 pandemic and veterans: An 
active intervention
Protocol Number:
8006
First Approval:
07/03/2020
Expiration Date:
No Expiration
Version Date:
10/06/2021
Contact Principal Investigator:
Yuval Neria, PHD
Email: ny126@columbia.edu
Telephone: 646-774-8092
Co-Investigator(s):
John Markowitz, MD
Doron Amsalem
Research Chief:
Helen Simpson, MD
Cover Sheet
Choose ONE option from the following that is applicable to your study
If you are creating a new protocol, select "I am submitting a new protocol." As 5 Year Renewals are no 
longer required, this option remains for historical purposes.
Department & Unaffiliated Personnel
Department
What Department does the PI belong to?
Anxiety Disorders Clinic
Within the department, what Center or group are you affiliated with, if any? 
PTSD Team
Unaffiliated Personnel
List investigators, if any, who will be participating in this protocol but are not affiliated with New York 
State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.
N/A

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Procedures
To create the protocol summary form, first indicate if this research will include any of the following 
procedures
   Internet-based Data Collection or Transmission
Population
Indicate which of the following populations will be included in this research
   Adults
   Adults over 50
Research Support/Funding
Will an existing internal account be used to support the project?
Yes
Describe internal account
Account RFMH: 2801D
Is the project externally funded or is external funding planned?
No
Study Location
Indicate if the research is/will be conducted at any of the following
   NYSPI
This protocol describes research conducted by the PI at other facilities/locations
No
Lay Summary of Proposed Research 
Lay Summary of Proposed Research
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, 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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In a sizable randomized controlled trial (N=2,000), with pre-, post- and follow-up assessments the aim is to 
(1) determine whether video-based intervention reduce self-stigma and social media use and increase help-
seeking behavior in relate to COVID-19 among people with military experience, and to (2) test the effect of 
the intervention in reducing symptoms of depression, anxiety and PTSD, that will be measured by Patient 
Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) and the Primary Care PTSD 
Screen for DSM-5 (PC-PTSD-5). 
Background, Significance and Rationale
Background, Significance and Rationale
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 world1. 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 increase 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 Syndrome (PTSD) symptoms are the most common.2 A recent 
study3 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. 

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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.4 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.5,6Applying strategies to reduce self-stigma and improve help seeking 
behavior among veterans may ameliorate impaired functioning and reduce risks for long-term psychiatric 
illness. Thornicroft7 showed that social contact is the most effective type of intervention to improve help-
seeking 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.8-10 
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.
Specific Aims and Hypotheses
Specific Aims and Hypotheses
In a sizable randomized controlled trial (N=2,000), with pre-, post- and follow-up assessments the aim is to 
(1) determine whether video-based intervention reduce self-stigma and social media use and increase help-
seeking behavior in relate to COVID-19 among people with military experience, and to (2) test the effect of 
the intervention in reducing symptoms of depression, anxiety and PTSD, that will be measured by Patient 
Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) and the Primary Care PTSD 
Screen for DSM-5 (PC-PTSD-5).
Hypotheses: That (1) the brief video is expected to have greater impact in reducing self-stigma, increasing 
help-seeking behavior and changing habits of social media use in relate to COVID-19 than a written 
vignette or control groups in comparison to pre-intervention and to non-video conditions, (2) the brief video 
is expected to have greater impact in reducing symptoms of depression and anxiety an PTSD. 
Description of Subject Population
Sample #1
Specify subject population
US Adults with military experience
Number of completers required to accomplish study aims
2000

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Projected number of subjects who will be enrolled to obtain required number of completers
2000
Age range of subject population
18-80
Gender, Racial and Ethnic Breakdown
It is expected the sample will roughly mirror the general United States adult population:
Anticipated gender distribution: 52% female, 48% male
Anticipated racial distribution: 79% white only, 13% African American only, 2% Asian only, 1% Native 
American, 5% 2+ races
Anticipated Hispanic Ethnic Distribution: 15% Hispanic, 85 % Non-Hispanic Description of subject 
population
Description of subject population
Participants recruited using Amazon Mechanical Turk (AMT) will be adults in the U.S. with military 
experience who are willing to complete an online experiment for a small financial reward.
Recruitment Procedures
Describe settings where recruitment will occur
Describe settings where recruitment will occur
Participants will be recruited via Amazon Mechanical Turk (AMT: https://www.mturk.com/mturk/). AMT 
is a website that allows interested persons to choose from a large number of tasks to perform, including 
completion of surveys, for small amounts of compensation. AMT requires users to be over 18 years old. For 
this study the age range will be defined as 18-80. No demographic restrictions will be placed on 
participants, other than being with military experience and a resident in the U.S.
How and by whom will subjects be approached and/or recruited? 
A posting (the Information Sheet attached to this protocol) will be listed on AMT once the study is approved 
by the IRB. Participants can peruse the tasks available via AMT and read the information posted if they 
desire. The posting will explain the terms and conditions of the study. If participants agree to the conditions 
and consent to participate, they will click on a link that will direct them to complete the study procedures via 
Qualtrics.com (a secure, online data-collection platform that will store the study data in a password- 
protected account); if they do not consent to the conditions, they will not participate.
How will the study be advertised/publicized? 
As stated above, a posting (the Information Sheet attached to this protocol) will be listed on AMT once the 
study is approved by the IRB. In answering "yes" to the question below about whether we have recruitment 
material requiring review, we are referring to the Information Sheet.
Do you have ads/recruitment material requiring review at this time? 
Yes
Does this study involve a clinical trial?
Yes
Concurrent Research Studies

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Will subjects in this study participate in or be recruited from other studies? 
No
Inclusion/Exclusion Criteria
Name the subject group/sub sample
AMT Participants
Create or insert table to describe the inclusion criteria and methods to ascertain them
 Study Criteria
 Method of Ascertainment
 Military experience and at 
least 18 years old
 AMT requires respondents to be at least 18 and 
to have military experience
 80 years old or younger
 AMT settings will be used to exclude 
participants over 80 years of age
 U.S. Residents
 AMT settings will be used to limit responses to 
users in the United States
Create or insert table to describe the exclusion criteria and methods to ascertain them
 Study Criteria
 Method of Ascertainment
 Aged younger than 
18
 AMT requires respondents to be at least 18
 No military 
experience
 AMT requires respondents to have military 
experience
Waiver of Consent/Authorization
Indicate if you are requesting any of the following consent waivers
Waiver of consent for use of records that include protected health information (a HIPAA waiver of 
Authorization) 
No
Waiver or alteration of consent
No
Waiver of documentation of consent 
Yes
Waiver of parental consent 
No

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Consent Procedures
Is eligibility screening for this study conducted under a different IRB protocol?
No
Describe procedures used to obtain consent during the screening process 
N/A
Describe Study Consent Procedures
As stated earlier, a posting (the Information Sheet attached to this protocol) will be listed on AMT once the 
study is approved by the IRB. Participants can peruse the tasks available via AMT and read the information 
posted if they desire. The posting will explain the terms and conditions of the study. If participants agree to 
the conditions and consent to participate, they will click on a link that will direct them to complete the study 
procedures via Qualtrics.com (a secure, online data-collection platform that will store the study data in a 
password-protected account); if they do not consent to the conditions, they will not participate.
Indicate which of the following are employed as a part of screening or main study consent procedures
   Information Sheet
Waiver of Documentation of Consent
Would the consent form signature be the only link between the subject’s identity and the research data?
Yes
Is breach of confidentiality the main study risk?
Yes
Describe the study component(s) for which waiver of documentation is requested
The information sheet will act as consent, but no signature will be obtained because the information sheet 
will be presented onscreen to participants recruited via the internet.
Persons designated to discuss and document consent
Select the names of persons designated to obtain consent/assent
Type in the name(s) not found in the above list
N/A
Study Procedures
Describe the procedures required for this study
The proposed research will examine the effects of video-based intervention in people with military 
experience. Participants will be randomly assigned to either a) video-based intervention featuring the 
personal story of a veteran who was deployed to Afghanistan and now suffering from COVID-19 related 
symptoms, and his straggles and barriers to care, (b) vignette intervention – a written description of the 
same personal story, (c) no-intervention control arm.

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Qualtrics.com (the platform used for data collection) will automatically randomly assign each participant to 
one of the three arms.
The video-based intervention comprises of roughly 90-second video with a veteran describing his attitude 
towards COVID-19 before and after he was tested positive and his personal barriers to treatment and 
recovery, his personal experience with the use of social media, his fears and anxieties (i.e., sharing his/her 
own lived experience). The vignette, a written description of the aforementioned story, will deliver the same 
information, but without the social contact component that the video presents. The video/vignette will be 
provided at the day one. Before and after each intervention, a survey will be provided to all groups. In day 
14, and day 30, a follow-up survey will be provided to all groups.
You can upload charts or diagrams if any
Assessment Instruments
Create a table or give a brief description of the instruments that will be used for assessment
Questions for the pre- and post-intervention (day 1) and follow-up (day 14 and day 30).
Baseline Questionnaire (will be conducted pre intervention only) will include four questions regarding 
demographics (age, sex, ethnicity and race). Based on previous studies it is estimated the response 
time will be around 30 seconds.
Three questionnaires will be conducted at pre- and post-intervention (day 1) and follow-up (day 14 
and day 30):
 
1. Attitude towards COVID-19 – attitude towards COVID-19 questions were adapted from a measure 
created by Berger et al. about stigma and fear towards people with HIV.11 The questionnaire will 
include six questions and based on previous studies it is estimated the response time for 50 seconds. 
2. Attitude towards seeking help - Attitude towards help seeking will be based on the ATSPPH-SF 
(Attitudes Towards Seeking Professional Psychological Help Scale), and will include 5 questions (0-
disagree, 3-agree). One table will be created to include all 5 questions in one screen. Based on previous 
studies it is estimated the response time will be around 40 seconds. 
3. COVID-19 related behaviors and experiences was developed by the researchers and will include six 
questions regarding social media use, news consumption, social contact, previous contact with a 
known COVID-19 patient and if the participant has been tested for COVID-19. It is estimated the 
response time will be around 50 seconds. 
Three questionnaires will assess clinical symptoms and will be conducted at pre-intervention (day 1) 
and follow-up (day 14 and day 30):
 
1. Gad-7 questionnaire will include 7 questions that assess anxiety
2. PHQ-9 questionnaire will include 9 questions to assess depression
3. Primary Care PTSD screen for DSM-5 will include 5 yes/no questions to assess PTSD. 
Three tables will be created, one for each questionnaire. Based on previous studies it is estimated the 
response time will be 150 seconds. 

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In sum, the estimate time for day 1 (pre and post intervention) is 8 minutes for intervention groups 
and 6 minutes for control. The estimate time for each follow up is 5 minutes (day 14 and 30).
Please attach copies, unless standard instruments are used
Research Related Delay to Treatment
Will research procedures result in a delay to treatment?
No
Treatment to be provided at the end of the study
None. No treatment is involved in this study, and the study does not prevent any participant from 
undergoing treatment for any medical problem.
Risks/Discomforts/Inconveniences 
Risks that could be encountered during the study period
Breach of confidentiality is the main risk of the study. Another potential risk is that participants may 
experience mild psychological distress when answering questions about COVID-19, due to its sensitive 
nature.
Describe procedures for minimizing risks
For both of these risks, participants will be reminded that their responses are completely anonymous and 
that they are free to select "prefer not to answer" if they do not wish to answer a question or end their study 
participation at any time. Further ways to address the risk of breach of confidentiality are discussed in the 
Methods to Protect Confidentiality section. 
Methods to Protect Confidentiality
Describe methods to protect confidentiality
AMT protects confidentiality in keeping with the Amazon.com privacy policies. No identifiable information 
concerning participants' responses is shared with anyone.
The investigators of this research will only have access to the anonymous responses and associated 
demographic data of the respondents. They will not have access to any identifiable information of the 
respondents, and therefore will be unable to identify any individual respondent. When setting up the data 
collection procedures on Qualtrics.com, settings available from Qualtrics will be used to ensure that IP 
addresses will not be collected.
Will the study be conducted under a certificate of confidentiality?
No

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Direct Benefits to Subjects  
Direct Benefits to Subjects
There is no foreseeable benefit to subjects.
Compensation and/or Reimbursement 
Will compensation or reimbursement for expenses be offered to subjects?
Yes
Please describe and indicate total amount and schedule of payment(s). 
Include justification for compensation amounts and indicate if there are bonus payments.
Participants will be compensated $3.30 in total for participating in the study ($1.10 for Day 1, $1.10 for the 
follow-up on Day 14, and $1.10 for the follow-up on Day 30), a competitive rate on AMT for such a short 
study. At the conclusion of each part of the study, a “completion code” is displayed to each participant by 
the Qualtrics software. Participants are instructed to input this code on the AMT web page where they 
signed up to participate in the study. Once a participant completes the study and inputs the correct code, the 
researchers will credit $1.10 to his/her AMT user account on each day of participation (for a possible total 
of $3.30). There are no bonus payments associated with this study. 
References
References
References
1. WHO: https://experience.arcgis.com/experience/685d0ace521648f8a5beeeee1b9125cd
2. Mittal D, Drummond KL, Blevins D, Curran G, Corrigan P, Sullivan G. Stigma associated with 
PTSD: Perceptions of treatment seeking combat veterans. Psychiatric rehabilitation journal. 2013 
Jun;36(2):86Gao J, Zheng P, Jia Y, et al. Mental health problems and social media exposure during 
COVID-19 outbreak. Available at SSRN 3541120. 2020 Feb 17.
3. C Henderson, S Evans-Lacko, G Thornicroft. Mental illness stigma, help seeking, and public health 
programs. Am J Public Health, 103 (2013), pp. 777-780.
4. Mittal D, Drummond KL, Blevins D, Curran G, Corrigan P, Sullivan G. Stigma associated with 
PTSD: Perceptions of treatment seeking combat veterans. Psychiatric rehabilitation journal. 2013 
Jun;36(2):86.
5. Smith JR, Workneh A, Yaya S. Barriers and Facilitators to Help-Seeking for Individuals with 
Posttraumatic Stress Disorder: A Systematic Review. J Trauma Stress. 2019 Nov 7. doi: 
10.1002/jts.22456. 
6. Rüsch N, Angermeyer MC, Corrigan PW. Mental illness stigma: concepts, consequences, and 
initiatives to reduce stigma. European psychiatry. 2005 Dec 1;20(8):529-39.
7. Thornicroft G, Mehta N, Clement S, Evans-Lacko S, Doherty M, Rose D, Koschorke M, Shidhaye 
R, O'Reilly C, Henderson C. Evidence for effective interventions to reduce mental-health-related 
stigma and discrimination. The Lancet. 2016 Mar 12;387(10023):1123-32

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8. Corrigan PW, Kleinlein P. The Impact of Mental Illness Stigma, On the Stigma of Mental Illness: 
Practical Strategies for Research and Social Change. American Psychological Association, 
Washington, DC. 2005.
9. Koike S, Yamaguchi S, Ojio Y, Ohta K, Shimada T, Watanabe K, Thornicroft G, Ando S. A 
randomised controlled trial of repeated filmed social contact on reducing mental illness-related 
stigma in young adults. Epidemiology and psychiatric sciences. 2018 Apr;27(2):199-208.
10. Clement S, van Nieuwenhuizen A, Kassam A, Flach C, Lazarus A, De Castro M, McCrone P, 
Norman I, Thornicroft G. Filmed v. live social contact interventions to reduce stigma: randomised 
controlled trial. The British Journal of Psychiatry. 2012 Jul;201(1):57-64.
11. Corrigan PW, Michaels PJ, Vega E, Gause M, Larson J, Krzyzanowski R, Botcheva L. Key 
ingredients to contact-based stigma change: A cross-validation. Psychiatric Rehabilitation Journal. 
2014 Mar;37(1):62.
12. Berger, B. E., Ferrans, C. E., & Lashley, F. R. (2001). Measuring stigma in people with HIV: 
Psychometric assessment of the HIV stigma scale. Research in Nursing & Health, 24(6), 518-529. 
Uploads
Upload copy(ies) of unbolded Information Sheet(s)
Upload copy(ies) of bolded Information Sheet(s)
Upload copy(ies) of recruitment materials/ads to be reviewed
Upload copy(ies) of the HIPAA form
Upload any additional documents that may be related to this study