Addressing COVID-19 Mental Health Problems Among US Veterans

October 26, 2021 updated by: Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Video-based intervention
A brief video about coping with COVID-19 stress presented to the participants
Three minutes video of a veteran that shares his personal story
EXPERIMENTAL: vignette intervention
A brief vignette about coping with COVID-19 stress presented to the participants
A written description of the content of the video
NO_INTERVENTION: Control
Only assessment, no intervention arrm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Help Seeking Intention
Time Frame: Assessed 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
Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Help Seeking Intentions Among Veterans Who Reported Anxiety, Depression, or PTSD
Time Frame: Assessed 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
Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yuval Neria Neria, PhD, Columbia University and NYSPI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2020

Primary Completion (ACTUAL)

October 20, 2020

Study Completion (ACTUAL)

October 26, 2020

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (ACTUAL)

July 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 8006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared as needed with investigators, IRB etc. A plan will be determined in the short future

IPD Sharing Time Frame

two months

IPD Sharing Access Criteria

Co-Is

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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