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Digital Mental Health Care for COVID-19 High-Risk Populations - Phase 2

NCT ID: NCT05826132

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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Stigma towards mental health care is a profound obstacle that interferes with individuals seeking these services. Research suggests that interventions that are based on social contact are the most efficient way to reduce stigma. A previous phase of this study also showed that participants of certain minority groups (Black participants and female participants) were more impacted by the intervention when it was delivered by a presenter who shared their demographic characteristics. By utilizing an online video intervention, this study aims to address stigma and empower essential workers (healthcare and non-healthcare workers) to seek treatment for mental health issues. As a secondary aim, this study will examine whether the intervention results in behavioral changes in help-seeking. The investigators will study this by adding a link to a database of mental health care providers and measuring the number of times participants click on the link. A total of 1,400 young adult members of these high-risk groups will be recruited to participate in a randomized controlled trial (RCT) testing the efficacy of the intervention.

The intervention will consist of brief videos in which empowered members of the respective high-risk group (presented by actors) share their COVID-19 related mental health problems and describe how they were able to confront their mental health problems, which in turn helped them seek mental health care. Within each high-risk group, individuals will first be randomized to receive either the video intervention, with content adjusted to the presenter's young adult, female, Latino identity, the intervention video without any identity-based content, or non-intervention control.

The study will randomize participants within each high-risk group into one of three arms:

1\) 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, using language that speaks to the specific experience of being a young Latina woman; 2) Non-Adjusted 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; 3) No Intervention (Control Arm): Participants randomized to this arm will view a video of the presenter describing daily activities, without mention of COVID-19 or mental health. Thirty days following the intervention, a follow-up assessment will examine longer-term effects.

Conditions

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Stigma, Social Help-Seeking Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Adjusted Content Intervention Video

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.

Group Type EXPERIMENTAL

Adjusted Content Intervention

Intervention Type OTHER

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

Non-Adjusted Intervention Video

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.

Group Type EXPERIMENTAL

Non-Adjusted Intervention Video

Intervention Type OTHER

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

Control Arm

Participants will watch a control video discussing daily activities.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adjusted Content Intervention

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

Intervention Type OTHER

Non-Adjusted 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Yuval Y Neria

Director of PTSD team at Columbia University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuval Neria, PhD

Role: PRINCIPAL_INVESTIGATOR

NYSPI and Columbia University

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 41159853 (View on PubMed)

Other Identifiers

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8128a

Identifier Type: -

Identifier Source: org_study_id