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BACKGROUND: The significant rise of mental health challenges during the COVID-19 pandemic has had crushing effects on the public health sector and economy. In order to meet this overwhelming and growing demand for mental health care, we must employ innovative approaches to significantly expand the capacity of mental healthcare delivery. While it is not feasible to increase the number of mental health care providers or the number of hours they work in the short term, improving their time efficiency may be a viable solution. Virtual and digital delivery of psychotherapy, which is shown to be efficient and clinically effective, might be a good candidate to address this growing demand. OBJECTIVE: The goal of this research protocol is to evaluate the feasibility and efficacy of treating mental health issues started or aggravated by the stressors associated with the COVID-19 pandemic using an online, digital and asynchronous model of care. METHODS: This non-randomized control trial intervention will be delivered through the Online Psychotherapy Tool (OPTT), a secure, cloud-based, digital mental health platform. Participants will be offered a 9-week online cognitive behavioural therapy (e-CBT) program tailored to address mental health problems in the context of the COVID-19 pandemic. This program will involve weekly self-guided educational material, providing an overview of behavioral skills, and completing related weekly homework. Participants (n = 80) will receive personalized feedback 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 completed by participants at baseline, week 5 and post-treatment. Inclusion criteria includes the capacity to consent, a primary diagnosis of generalized anxiety disorder and/or major depressive disorder with symptoms that have started or gotten worse during the COVID-19 pandemic, the ability to speak and read English, and having consistent and reliable access to the Internet. Exclusion criteria includes active psychosis, acute mania, severe alcohol or substance use disorder, and/or active suicidal or homicidal ideation. RESULTS: The study received funding in May 2020. Ethics approval was received in June 2020, and 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 (35 in the intervention group and 23 in the control group). Data collection is expected to conclude by the end of 2020, and analyses are expected to be completed by February 2021 with linear regression analysis (for continuous outcomes) and binomial regression analysis (for categorical outcomes) being conducted. CONCLUSIONS: If proven feasible, this method of care delivery could increase care capacity by up to four-folds. The findings from this project have the potential to influence clinical practices and policies, and to increase accessibility to care during the COVID-19 pandemic, without sacrificing the quality of care. CLINICALTRIAL: ClinicalTrials.Gov Protocol Registration and Results System (NCT0446667); https://clinicaltrials.gov/ct2/show/NCT04476667.
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