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Brief Video-based InterventionNCT04484207

Addressing COVID-19 Mental Health Problems Among US Veterans

A study testing A short video intervention and A vignette intervention in people with Brief Video-based Intervention and Vignette Based Intervention, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
A short video intervention and A vignette intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteUnited States
Study dates
6 Jul 2020to 26 Oct 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New York State Psychiatric Institute

    New York, New York, 10032

Other trials in United States

About this study

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.

Read the 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.

Being tested
A short video intervention, A vignette intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A short video interventionOther

    Three minutes video of a veteran that shares his personal story

  • A vignette interventionOther

    A written description of the content of the video

Study groups in NCT04484207
Study groupRoleWhat they receive
Video-based interventionExperimentalA brief video about coping with COVID-19 stress presented to the participants
Receives: Other: A short video intervention
vignette interventionExperimentalA brief vignette about coping with COVID-19 stress presented to the participants
Receives: Other: A vignette intervention
ControlNo interventionOnly assessment, no intervention arrm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Help Seeking Intention

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

    Measured: Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)

Secondary outcomes (1)
  1. 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

    Measured: Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2020
  2. Study start6 Jul 2020
  3. Primary completion20 Oct 2020
  4. Study completion26 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04484207
Sponsor's protocol ID
8006
Status last verified
Oct 2021
First submitted
21 Jul 2020
Last updated
28 Oct 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared as needed with investigators, IRB etc. A plan will be determined in the short future

Publications

  • 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.

    PubMed 33734539

Questions about this trial

What is this clinical trial studying?

A study testing A short video intervention and A vignette intervention in people with Brief Video-based Intervention and Vignette Based Intervention, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04484207, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.

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