Digital Mental Health Care for COVID-19 High-Risk Populations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 4,134
- Locations
- 1
- Primary Endpoint
- Stigma (3 items of the SSOSH-3)
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Essential workers (including healthcare workers)
- •Age of 18-80
- •US resident
- •English speaker
Exclusion Criteria
- Not provided
Arms & Interventions
Video and behavioral change module (BCM) + booster
Participants will watch the video and read the BCM twice (day 1 and day 14)
Intervention: Video _ behavioral change module (Behavioral)
Video and behavioral change module (BCM)
Participants will watch the video and read the BCM once (day 1 only)
Intervention: Video _ behavioral change module (Behavioral)
Control
This arm will recieved the same length video with a content that is not related to mental health and no BCM
Outcomes
Primary Outcomes
Stigma (3 items of the SSOSH-3)
Time Frame: 90 days after the intervention
Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)
Stigma (the SSOSH-3)
Time Frame: immediately after the intervention
Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)
Help Seeking Intentions (3 items of the ATSPPH)
Time Frame: 90 days after the intervention
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
Stigma (3 items of the SSOSH-3)
Time Frame: 14 days after the intervention
Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)
Stigma (3 items of the SSOSH-3)
Time Frame: 30 days after the intervention
Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)
Help Seeking Intentions (3 items of the ATSPPH)
Time Frame: Immediately after the intervention
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
Help Seeking Intentions (3 items of the ATSPPH)
Time Frame: 14 days after the intervention
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
Help Seeking Intentions (3 items of the ATSPPH)
Time Frame: 30 days after the intervention
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
Secondary Outcomes
- Clinical outcome - Anxiety(90 days after the intervention)
- Clinical outcome - PTSD(90 days after the intervention)
- Behaviors questionnaire(90 days after the intervention)
- Clinical outcome - Depression(90 days after the intervention)
- Behaviors questionnaire(14 days after the intervention)
- Behaviors questionnaire(30 days after the intervention)
- Clinical outcome - Anxiety(14 days after the intervention)
- Clinical outcome - Anxiety(30 days after the intervention)
- Clinical outcome - Depression(14 days after the intervention)
- Clinical outcome - Depression(30 days after the intervention)
- Clinical outcome - PTSD(14 days after the intervention)
- Clinical outcome - PTSD(30 days after the intervention)
Investigators
Yuval Y Neria
Director of PTSD team at Columbia University
Research Foundation for Mental Hygiene, Inc.