NCT05826132

Brief Summary

The mental health consequences of the COVID-19 (Coronavirus Disease of 2019) 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, emergency medical technicians) 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. Additionally, our previous findings have shown that among these higher risk individuals, young adults and women reported greater levels of clinical symptoms. 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 with an eye toward the young adult portion of this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

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

April 20, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

April 20, 2023

Last Update Submit

December 13, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Stigma (the Self Stigma of Seeking Help Scale - 3 item) (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)

    30 days after the intervention

  • Help Seeking Intentions (3 items of the Attitudes Toward Seeking Professional Psychological Help) (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)

    30 days after the intervention

Secondary Outcomes (1)

  • Number of Referral Clicks

    Immediately after the intervention

Study Arms (3)

Adjusted Content Intervention Video

EXPERIMENTAL

Participants will watch a 2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, using language that speaks to the specific experience of being a young Latina woman.

Other: Adjusted Content Intervention

Non-Adjusted Intervention Video

EXPERIMENTAL

Participants will watch a 2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, without any language alluding to her particular identity characteristics.

Other: Non-Adjusted Intervention Video

Control Arm

NO INTERVENTION

Participants will watch a control video discussing daily activities.

Interventions

2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, using language that speaks to the specific experience of being a young Latina woman

Adjusted Content Intervention Video

2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, without any language alluding to her particular identity characteristics

Non-Adjusted Intervention Video

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Essential worker
  • Ages 18-35
  • English-speaking, able to provide consent

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 (1)

  • Fisch CT, Lazarov A, Lewis-Fernandez R, Dixon LB, Neria Y, Amsalem D. Brief Video Intervention to Increase Treatment-Seeking Intentions Among Young Adults With Psychiatric Symptoms: A Randomized Controlled Trial. J Clin Psychiatry. 2025 Oct 27;86(4):25m15881. doi: 10.4088/JCP.25m15881.

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 controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of PTSD team at Columbia University

Study Record Dates

First Submitted

April 20, 2023

First Posted

April 24, 2023

Study Start

May 1, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

No identifying data of participants will be shared

Locations