Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 10, 2023
Open Peer Review Period: May 10, 2023 - Jul 5, 2023
Date Accepted: Jul 24, 2023
Date Submitted to PubMed: Aug 17, 2023
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Comparing the efficacy of an electronically delivered cognitive behavioural therapy program to a mental health check-in program for generalized anxiety disorder: Protocol for a randomized trial
ABSTRACT
Background:
Generalized anxiety disorder (GAD) is a prevalent anxiety disorder with cognitive behavioural therapy (CBT) being the gold-standard treatment. However, it is inaccessible and costly to many as the mental health industry is overwhelmed by the demand for treatment. This means effective, accessible, and time-saving strategies must be developed to combat these problems. Online interventions for mental health disorders are an innovative and promising way to address these barriers. While the electronic delivery of CBT (e-CBT) has already proved productive and scalable for treating anxiety, other less resource-intensive interventions can be innovated. Checking up on one's mental health face to face has been shown to provide similar benefits to patients with anxiety disorders previously, but more research is needed to evaluate the efficacy of online delivery of this intervention.
Objective:
This study will compare the efficacy of e-CBT and a virtual mental health check-in program to treat GAD. These programs will both be delivered through a secure, online, care delivery platform.
Methods:
Participants (n = 100) over 18 years with a confirmed diagnosis of GAD will be randomly allocated to either an e-CBT program or a mental health check-in program over 12 weeks to address their anxiety symptoms. Participants in the e-CBT arm will complete pre-designed modules and homework assignments while receiving personalized feedback and asynchronous interaction with a therapist through the platform. Participants in the mental health check-in arm will be contacted weekly through the online platform’s written chat feature (messaging system). Therapists will ask the participants a series of pre-designed questions that revolve around a different theme each week to prompt conversation. Using clinically validated questionnaires, the efficacy of the e-CBT arm will be compared to the mental health check-in arm. These questionnaires will be completed at baseline, week 6, week 12, and at a 6-month follow-up.
Results:
The study received ethics approval in April 2021 and participant recruitment began in May 2021. Participant recruitment has been conducted through targeted advertisements and physician referrals. Complete data collection and analysis are expected to conclude by August 2022. Linear and binomial regression (continuous and categorical outcomes respectively) will be conducted.
Conclusions:
To the research team’s knowledge, this will be the first study, to date, comparing the efficacy of e-CBT with an online mental health check-in program to treat GAD. The findings from this study can help progress the development of more scalable, accessible, and efficacious mental health treatments. Clinical Trial: clinicaltrials.gov (NCT04754438)
Citation
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Copyright
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