Clinical trial NCT04964570: Digital Mental Health Care for COVID-19 High-Risk Populations
Official title: Digital Mental Health Care for COVID-19 High-Risk Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stigma, Social
Help-Seeking Behavior
Lead sponsor: Research Foundation for Mental Hygiene, Inc.
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2021-07-16
Enrollment: 4134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controled Trial
Primary purpose: OTHER

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.

Detailed description: 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. By combining online video and interactive behavioral change modules, this study aims to address stigma and both empower essential workers (healthcare and non-healthcare workers) both to seek treatment for mental health issues as well as to reduce psychiatric symptoms by increasing social support, facilitating sleep hygiene, and maintaining physical exercise. A total of 4,200 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. The video will be followed by a short, interactive, digital behavioral change module. Within each high-risk group, individuals will first be randomized to receive the video (one time), video plus booster (second administration of the video), or non-intervention video control.

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

1) Video + Behavioral Change Module, with Booster: 2-3-minute video (in which empowered members of the respective high-risk group (protagonists) 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) will be followed by 3-4-minute online digital behavioral change modules at days 1 and 14 of the study ("video+booster"); 2) Video + Behavioral change modules without Booster: 2-3-minute video will be followed by 3-4-minute online digital behavioral change modules at day 1 only ("video"); 3) No Intervention video (Control Arm): Participants randomized to this arm will receive video not related to mental health ("control"). Following the intervention, the study includes three follow-ups (day 14, 30, and 90) to examine longer-term effects.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Stigma (the SSOSH-3)
timeFrame: immediately after the intervention
measure: Stigma (3 items of the SSOSH-3)
timeFrame: 14 days after the intervention
measure: Stigma (3 items of the SSOSH-3)
timeFrame: 30 days after the intervention
measure: Stigma (3 items of the SSOSH-3)
timeFrame: 90 days after the intervention
measure: Help Seeking Intentions (3 items of the ATSPPH)
timeFrame: Immediately after the intervention
measure: Help Seeking Intentions (3 items of the ATSPPH)
timeFrame: 14 days after the intervention
measure: Help Seeking Intentions (3 items of the ATSPPH)
timeFrame: 30 days after the intervention
measure: Help Seeking Intentions (3 items of the ATSPPH)
timeFrame: 90 days after the intervention
Secondary outcomes:
measure: Behaviors questionnaire
timeFrame: 14 days after the intervention
measure: Behaviors questionnaire
timeFrame: 30 days after the intervention
measure: Behaviors questionnaire
timeFrame: 90 days after the intervention
measure: Clinical outcome - Anxiety
timeFrame: 14 days after the intervention
measure: Clinical outcome - Anxiety
timeFrame: 30 days after the intervention
measure: Clinical outcome - Anxiety
timeFrame: 90 days after the intervention
measure: Clinical outcome - Depression
timeFrame: 14 days after the intervention
measure: Clinical outcome - Depression
timeFrame: 30 days after the intervention
measure: Clinical outcome - Depression
timeFrame: 90 days after the intervention
measure: Clinical outcome - PTSD
timeFrame: 14 days after the intervention
measure: Clinical outcome - PTSD
timeFrame: 30 days after the intervention
measure: Clinical outcome - PTSD
timeFrame: 90 days after the intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: NYSPI and Columbia University
name: Yuval Neria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.