Alavi Nazanin, Yang Megan, Stephenson Callum, Nikjoo Niloofar, Malakouti Niloufar, Layzell Gina, Jagayat Jasleen, Shirazi Amirhossein, Groll Dianne, Omrani Mohsen, O'Riordan Anne, Khalid-Khan Sarosh, Freire Rafael, Brietzke Elisa, Gomes Fabiano Alves, Milev Roumen, Soares Claudio N
Department of Psychiatry, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada.
Centre for Neuroscience Studies, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada.
JMIR Res Protoc. 2020 Dec 18;9(12):e24913. doi: 10.2196/24913.
The considerable rise of mental health challenges during the COVID-19 pandemic has had detrimental effects on the public health sector and economy. To meet the overwhelming and growing demand for mental health care, innovative approaches must be employed to significantly expand mental health care delivery capacity. Although it is not feasible to increase the number of mental health care providers or hours they work in the short term, improving their time efficiency may be a viable solution. Virtually and digitally delivering psychotherapy, which has been shown to be efficient and clinically effective, might be a good method for addressing this growing demand.
This research protocol aims to evaluate the feasibility and efficacy of using an online, digital, asynchronous care model to treat mental health issues that are started or aggravated by stressors associated with the COVID-19 pandemic.
This nonrandomized controlled trial intervention will be delivered through the Online Psychotherapy Tool, a secure, cloud-based, digital mental health platform. Participants will be offered a 9-week electronically delivered cognitive behavioral therapy program that is tailored to address mental health problems in the context of the COVID-19 pandemic. This program will involve weekly self-guided educational material that provides an overview of behavioral skills and weekly homework. Participants (N=80) will receive personalized feedback from and weekly interaction with a therapist throughout the course of the program. The efficacy of the program will be evaluated using clinically validated symptomology questionnaires, which are to be completed by participants at baseline, week 5, and posttreatment. Inclusion criteria includes the capacity to consent; a primary diagnosis of generalized anxiety disorder or major depressive disorder, with symptoms that started or worsened during the COVID-19 pandemic; the ability to speak and read English; and consistent and reliable access to the internet. Exclusion criteria includes active psychosis, acute mania, severe alcohol or substance use disorder, and active suicidal or homicidal ideation.
This study received funding in May 2020. Ethics approval was received in June 2020. The recruitment of participants began in June 2020. Participant recruitment is being conducted via social media, web-based communities, and physician referrals. To date, 58 participants have been recruited (intervention group: n=35; control group: n=23). Data collection is expected to conclude by the end of 2020. Analyses (ie, linear regression analysis for continuous outcomes and binomial regression analysis for categorical outcomes) are expected to be completed by February 2021.
If proven feasible, this care delivery method could increase care capacity by up to fourfold. The findings from this study can potentially influence clinical practices and policies and increase accessibility to care during the COVID-19 pandemic, without sacrificing the quality of care.
ClinicalTrials.gov NCT04476667; https://clinicaltrials.gov/ct2/show/NCT04476667.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24913.
在新冠疫情期间，心理健康挑战显著增加，对公共卫生部门和经济产生了不利影响。为满足对心理健康护理压倒性且不断增长的需求，必须采用创新方法大幅扩大心理健康护理的提供能力。虽然短期内增加心理健康护理提供者数量或其工作时长不可行，但提高他们的时间效率可能是一个可行的解决方案。虚拟和数字化提供心理治疗已被证明是高效且临床有效的，可能是满足这一不断增长需求的好方法。
本研究方案旨在评估使用在线、数字、异步护理模式治疗由新冠疫情相关应激源引发或加重的心理健康问题的可行性和有效性。
这项非随机对照试验干预将通过在线心理治疗工具进行，这是一个安全的、基于云的数字心理健康平台。将为参与者提供一个为期9周的电子认知行为治疗项目，该项目针对新冠疫情背景下的心理健康问题进行了定制。该项目将包括每周的自我指导教育材料，提供行为技能概述和每周作业。参与者（N = 80）在整个项目过程中将从治疗师那里获得个性化反馈并每周进行互动。将使用经过临床验证的症状问卷评估该项目的有效性，参与者需在基线、第5周和治疗后完成这些问卷。纳入标准包括同意的能力；广泛性焦虑障碍或重度抑郁症的初步诊断，症状在新冠疫情期间开始或加重；说英语和读英语的能力；以及持续可靠的互联网接入。排除标准包括活动性精神病、急性躁狂症、严重酒精或物质使用障碍以及活动性自杀或杀人意念。
本研究于2020年5月获得资金。2020年6月获得伦理批准。参与者招募于2020年6月开始。通过社交媒体、网络社区和医生推荐进行参与者招募。截至目前，已招募58名参与者（干预组：n = 35；对照组：n = 23）。数据收集预计在2020年底结束。分析（即对连续结果进行线性回归分析，对分类结果进行二项式回归分析）预计在2021年2月完成。
如果证明可行，这种护理提供方式可将护理能力提高多达四倍。本研究结果可能会影响临床实践和政策，并在新冠疫情期间增加护理的可及性，同时不牺牲护理质量。
ClinicalTrials.gov NCT04476667；https://clinicaltrials.gov/ct2/show/NCT04476667。
国际注册报告识别码（IRRID）：DERR1-10.2196/24913。
