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

Stigma, Social Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964570
• Other study ID #: 8128
• Status: Completed
• Phase: N/A
• Start date: August 4, 2021
• Est. completion date: December 25, 2021

Study information

• Verified date: February 2022
• Source: Research Foundation for Mental Hygiene, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4134
• Est. completion date: December 25, 2021
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Essential workers (including healthcare workers)

• Age of 18-80

• US resident

• English speaker

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Help-Seeking Behavior
• Stigma, Social

Intervention

Behavioral:
• Video _ behavioral change module
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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Research Foundation for Mental Hygiene, Inc.	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stigma (the SSOSH-3)	Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)	immediately after the intervention
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Clinical outcome - Anxiety	Change from baseline in GAD-7 (range 0-21, higher score indicate more anxiety)	14 days after the intervention
Secondary	Clinical outcome - Anxiety	Change from baseline in GAD-7 (range 0-21, higher score indicate more anxiety)	30 days after the intervention
Secondary	Clinical outcome - Anxiety	Change from baseline in GAD-7 (range 0-21, higher score indicate more anxiety)	90 days after the intervention
Secondary	Clinical outcome - Depression	Change from baseline in PHQ-9 (range 0-27, higher score indicate more depression)	14 days after the intervention
Secondary	Clinical outcome - Depression	Change from baseline in PHQ-9 (range 0-27, higher score indicate more depression)	30 days after the intervention
Secondary	Clinical outcome - Depression	Change from baseline in PHQ-9 (range 0-27, higher score indicate more depression)	90 days after the intervention
Secondary	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
Secondary	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
Secondary	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