Comparing the Efficacy of an Electronically Delivered Cognitive Behavioral Therapy Program to a Mental Health Check-In Program for Generalized Anxiety Disorder: Protocol for a Randomized Trial
Authors: Stephenson Callum , Kumar Anchan , Malakouti Niloufar , Nikjoo Niloofar , Jagayat Jasleen , Gizzarelli Tessa , Patel Charmy , Gutierrez Gilmar , Shirazi Amirhossein , Yang Megan , Omrani Mohsen , Alavi Nazanin 
Published: July 2023

Background
Generalized anxiety disorder (GAD) is a prevalent anxiety disorder, with cognitive behavioral 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. Web-based interventions for mental health disorders are an innovative and promising way to address these barriers. While electronically delivered CBT (e-CBT) has already proved productive and scalable for treating anxiety, other less resource-intensive interventions can be innovated. Checking up on 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 web-based delivery of this intervention.

Objective
This study will compare the efficacy of e-CBT and a web-based mental health check-in program to treat GAD. These programs will both be delivered through a secure, web-based care delivery platform.

Methods
We will randomly allocate participants (N=100) who are 18 years or older with a confirmed diagnosis of GAD 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 predesigned 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 web-based platform’s written chat feature (messaging system). Therapists will ask the participants a series of predesigned 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, and week 12.

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 2023. 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 a web-based 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.

Trial Registration
ClinicalTrials.gov NCT04754438; https://classic.clinicaltrials.gov/ct2/show/NCT04754438

International Registered Report Identifier (IRRID)
DERR1-10.2196/48899