Digital Mental Health Care for COVID-19 High-Risk Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,134
- 试验地点
- 1
- 主要终点
- Stigma (3 items of the SSOSH-3)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Essential workers (including healthcare workers)
- •Age of 18-80
- •US resident
- •English speaker
排除标准
- 未提供
结局指标
主要结局
Stigma (3 items of the SSOSH-3)
时间窗: 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)
时间窗: 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)
时间窗: 90 days after the intervention
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
次要结局
- 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)
研究者
Yuval Y Neria
Director of PTSD team at Columbia University
Research Foundation for Mental Hygiene, Inc.