NCT04484207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 28, 2021

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

July 21, 2020

Results QC Date

October 12, 2021

Last Update Submit

October 26, 2021

Conditions

Brief Video-based InterventionVignette Based InterventionNon Intervention Control Arm

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

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

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

Study Arms (3)

Video-based intervention

EXPERIMENTAL

A brief video about coping with COVID-19 stress presented to the participants

Other: A short video intervention

vignette intervention

EXPERIMENTAL

A brief vignette about coping with COVID-19 stress presented to the participants

Other: A vignette intervention

Control

NO INTERVENTION

Only assessment, no intervention arrm

Interventions

A short video interventionOTHER

Three minutes video of a veteran that shares his personal story

Video-based intervention
A vignette interventionOTHER

A written description of the content of the video

vignette intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 33734539DERIVED

Results Point of Contact

Title
Yuval Y. Neria
Organization
New York State Psychiatric Institute
ny126@cumc.columbia.edu
646-774-8092

Study Officials

  • Yuval Neria Neria, PhD

    Columbia University and NYSPI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medical Psychology

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 23, 2020

Study Start

July 6, 2020

Primary Completion

October 20, 2020

Study Completion

October 26, 2020

Last Updated

October 28, 2021

Results First Posted

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
two months
Access Criteria
Co-Is

Locations

US(1)