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

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: 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.

Official Title
-----------------
Digital Mental Health Care for COVID-19 High-Risk Populations

Conditions
-----------------
Stigma, Social, Help-Seeking Behavior

Intervention / Treatment
-----------------
* Behavioral: Video _ behavioral change module


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Essential workers (including healthcare workers) Age of 18-80 US resident English speaker Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video and behavioral change module (BCM) + booster<br>Participants will watch the video and read the BCM twice (day 1 and day 14) | Behavioral: Video _ behavioral change module<br>* 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.<br>|
| Experimental: Video and behavioral change module (BCM)<br>Participants will watch the video and read the BCM once (day 1 only) | Behavioral: Video _ behavioral change module<br>* 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.<br>|
| No Intervention: Control<br>This arm will recieved the same length video with a content that is not related to mental health and no BCM | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behaviors questionnaire | Four questions about sleep (quality of sleep), exercise (amount of weekly exercise) and social habits (weekly number of people one contacted). We will measure change from baseline | 14 days after the intervention | 
| Behaviors questionnaire | Four questions about sleep (quality of sleep), exercise (amount of weekly exercise) and social habits (weekly number of people one contacted). We will measure change from baseline | 30 days after the intervention | 
| Behaviors questionnaire | Four questions about sleep (quality of sleep), exercise (amount of weekly exercise) and social habits (weekly number of people one contacted). We will measure change from baseline | 90 days after the intervention | 
| Clinical outcome - Anxiety | Change from baseline in GAD-7 (range 0-21, higher score indicate more anxiety) | 14 days after the intervention | 
| Clinical outcome - Anxiety | Change from baseline in GAD-7 (range 0-21, higher score indicate more anxiety) | 30 days after the intervention | 
| Clinical outcome - Anxiety | Change from baseline in GAD-7 (range 0-21, higher score indicate more anxiety) | 90 days after the intervention | 
| Clinical outcome - Depression | Change from baseline in PHQ-9 (range 0-27, higher score indicate more depression) | 14 days after the intervention | 
| Clinical outcome - Depression | Change from baseline in PHQ-9 (range 0-27, higher score indicate more depression) | 30 days after the intervention | 
| Clinical outcome - Depression | Change from baseline in PHQ-9 (range 0-27, higher score indicate more depression) | 90 days after the intervention | 
| Clinical outcome - PTSD | Change from baseline in PC-PTSD (range 0-5, higher than 2 indicates high probability of PTSD) | 14 days after the intervention | 
| Clinical outcome - PTSD | Change from baseline in PC-PTSD (range 0-5, higher than 2 indicates high probability of PTSD) | 30 days after the intervention | 
| Clinical outcome - PTSD | Change from baseline in PC-PTSD (range 0-5, higher than 2 indicates high probability of PTSD) | 90 days after the intervention |