NCT04964570

Brief Summary

The mental health consequences of the COVID-19 pandemic are likely to be vast, exceeding the capacity of mental health services and delaying treatment for people in need, with devastating consequences for those affected. Emerging data suggest that frontline health workers (e.g. physicians, nurses, EMTs) and essential workers (in industries such as energy, and food products and services) face particular risks for mental health problems during and after the COVID-19 outbreak. To address the unprecedented mental health needs during and as a result of the COVID-19 pandemic this study will develop and test novel, cost-effective and scalable, digitally-delivered mental health interventions, and will test this approach by focusing on health care workers and other essential workers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,134

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

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

First Submitted

Initial submission to the registry

July 13, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

August 4, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

July 13, 2021

Last Update Submit

February 15, 2022

Conditions

Stigma, SocialHelp-Seeking Behavior

Outcome Measures

Primary Outcomes (8)

  • Stigma (the SSOSH-3)

    Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)

    immediately after the intervention

  • Stigma (3 items of the SSOSH-3)

    Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)

    14 days after the intervention

  • Stigma (3 items of the SSOSH-3)

    Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)

    30 days after the intervention

  • Stigma (3 items of the SSOSH-3)

    Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)

    90 days after the intervention

  • Help Seeking Intentions (3 items of the ATSPPH)

    Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)

    Immediately after the intervention

  • Help Seeking Intentions (3 items of the ATSPPH)

    Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)

    14 days after the intervention

  • Help Seeking Intentions (3 items of the ATSPPH)

    Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)

    30 days after the intervention

  • Help Seeking Intentions (3 items of the ATSPPH)

    Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)

    90 days after the intervention

Secondary Outcomes (12)

  • Behaviors questionnaire

    14 days after the intervention

  • Behaviors questionnaire

    30 days after the intervention

  • Behaviors questionnaire

    90 days after the intervention

  • Clinical outcome - Anxiety

    14 days after the intervention

  • Clinical outcome - Anxiety

    30 days after the intervention

  • +7 more secondary outcomes

Study Arms (3)

Video and behavioral change module (BCM) + booster

EXPERIMENTAL

Participants will watch the video and read the BCM twice (day 1 and day 14)

Behavioral: Video _ behavioral change module

Video and behavioral change module (BCM)

EXPERIMENTAL

Participants will watch the video and read the BCM once (day 1 only)

Behavioral: Video _ behavioral change module

Control

NO INTERVENTION

This arm will recieved the same length video with a content that is not related to mental health and no BCM

Interventions

Video _ behavioral change moduleBEHAVIORAL

A short video (primary outcome) that aimed at reducing stigma towards treatments and increasing help seeking intentions. The behavioral change module (secondary outcome) is aimed at changing behaviors of sleep, exercise and social support.

Video and behavioral change module (BCM)Video and behavioral change module (BCM) + booster

Eligibility Criteria

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

You may qualify if:

  • Essential workers (including healthcare workers)
  • Age of 18-80
  • US resident
  • English speaker

You may not qualify if:

  • N/A

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 (3)

  • Amsalem D, Fisch CT, Wall M, Liu J, Lazarov A, Markowitz JC, LeBeau M, Hinds M, Thompson K, Smith TE, Lewis-Fernandez R, Dixon LB, Neria Y. The role of income and emotional engagement in the efficacy of a brief help-seeking video intervention for essential workers. J Psychiatr Res. 2024 May;173:232-238. doi: 10.1016/j.jpsychires.2024.03.027. Epub 2024 Mar 27.

    PMID: 38554618DERIVED

  • Amsalem D, Wall M, Lazarov A, Markowitz JC, Fisch CT, LeBeau M, Hinds M, Liu J, Fisher PW, Smith TE, Hankerson S, Lewis-Fernandez R, Neria Y, Dixon LB. Destigmatising mental health treatment and increasing openness to seeking treatment: randomised controlled trial of brief video interventions. BJPsych Open. 2022 Sep 16;8(5):e169. doi: 10.1192/bjo.2022.575.

    PMID: 36111611DERIVED

  • Amsalem D, Wall M, Lazarov A, Markowitz JC, Fisch CT, LeBeau M, Hinds M, Liu J, Fisher PW, Smith TE, Hankerson S, Lewis-Fernandez R, Dixon LB, Neria Y. Brief Video Intervention to Increase Treatment-Seeking Intention Among U.S. Health Care Workers: A Randomized Controlled Trial. Psychiatr Serv. 2023 Feb 1;74(2):119-126. doi: 10.1176/appi.ps.20220083. Epub 2022 Sep 13.

    PMID: 36097721DERIVED

MeSH Terms

Conditions

Social StigmaHelp-Seeking Behavior

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Yuval Neria, PhD

    NYSPI and Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Controled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of PTSD team at Columbia University

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 16, 2021

Study Start

August 4, 2021

Primary Completion

December 25, 2021

Study Completion

December 25, 2021

Last Updated

February 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

No identifying data of participants will be shared

Locations

US(1)