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Completed

NCT Number: NCT04964570

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Video _ behavioral change module

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

Secondary outcomes

  1. Behaviors questionnaire

    Time frame: 14 days after the intervention

    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

  2. Behaviors questionnaire

    Time frame: 30 days after the intervention

    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

  3. Behaviors questionnaire

    Time frame: 90 days after the intervention

    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

  4. Clinical outcome - Anxiety

    Time frame: 14 days after the intervention

    Change from baseline in GAD-7 (range 0-21, higher score indicate more anxiety)

  5. Clinical outcome - Anxiety

    Time frame: 30 days after the intervention

    Change from baseline in GAD-7 (range 0-21, higher score indicate more anxiety)

  6. Clinical outcome - Anxiety

    Time frame: 90 days after the intervention

    Change from baseline in GAD-7 (range 0-21, higher score indicate more anxiety)

  7. Clinical outcome - Depression

    Time frame: 14 days after the intervention

    Change from baseline in PHQ-9 (range 0-27, higher score indicate more depression)

  8. Clinical outcome - Depression

    Time frame: 30 days after the intervention

    Change from baseline in PHQ-9 (range 0-27, higher score indicate more depression)

  9. Clinical outcome - Depression

    Time frame: 90 days after the intervention

    Change from baseline in PHQ-9 (range 0-27, higher score indicate more depression)

  10. Clinical outcome - PTSD

    Time frame: 14 days after the intervention

    Change from baseline in PC-PTSD (range 0-5, higher than 2 indicates high probability of PTSD)

  11. Clinical outcome - PTSD

    Time frame: 30 days after the intervention

    Change from baseline in PC-PTSD (range 0-5, higher than 2 indicates high probability of PTSD)

  12. Clinical outcome - PTSD

    Time frame: 90 days after the intervention

    Change from baseline in PC-PTSD (range 0-5, higher than 2 indicates high probability of PTSD)

Sponsors and collaborators

Lead sponsor

Research Foundation for Mental Hygiene, Inc.

Other

Collaborators

  • Columbia University

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2021
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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