Feasibility and Efficacy of Delivering Cognitive Behavioral Therapy Through an Online Psychotherapy Tool for Depression: Protocol for a Randomized Controlled Trial
Authors: Alavi Nazanin , Stephenson Callum , Yang Megan , Kumar Anchan , Shao Yijia , Miller Shadé , Yee Caitlin S , Stefatos Anthi , Gholamzadehmir Maedeh , Abbaspour Zara , Jagayat Jasleen , Shirazi Amirhossein , Omrani Mohsen , Patel Archana , Patel Charmy , Groll Dianne 
Published: May 2021

Background
Major depressive disorder (MDD) is a prevalent and debilitating mental health disorder. Among different therapeutic approaches (eg, medication and psychotherapy), psychotherapy in the form of cognitive behavioral therapy (CBT) is considered the gold standard treatment for MDD. However, although efficacious, CBT is not readily accessible to many patients in need because of hurdles such as stigma, long wait times, high cost, the large time commitment for health care providers, and cultural or geographic barriers. Electronically delivered cognitive behavioral therapy (e-CBT) can effectively address many of these accessibility barriers.

Objective
This study aims to investigate the efficacy and feasibility of implementing an e-CBT program compared with in-person treatment for MDD. It is hypothesized that the e-CBT program will offer results comparable with those of the in-person treatment program, regarding symptom reduction and quality of life improvement.

Methods
This nonrandomized controlled trial intervention will provide e-CBT for MDD through the Online Psychotherapy Tool, a secure, cloud-based, digital mental health platform. Participants (aged 18-65 years) will be offered 12 weekly sessions of an e-CBT program tailored to MDD to address their depressive symptoms. Participants (n=55) will complete predesigned modules and homework assignments while receiving personalized feedback and interacting with a therapist through the platform. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be compared with that of a group (n=55) receiving in-person CBT. Questionnaires will be completed at baseline, at week 6 and week 12, and at a 6-month follow-up. Focus groups will be conducted to investigate personal, cultural, and social factors impacting the accessibility and feasibility of implementing a web-based psychotherapy tool from a patient and care provider perspective. Inclusion criteria include diagnosis of MDD, competence to consent to participate, ability to speak and read English, and consistent and reliable access to the internet. Exclusion criteria include active psychosis, acute mania, severe alcohol or substance use disorder, and active suicidal or homicidal ideation.

Results
Ethics approval was obtained in January 2019, and recruitment of participants began in June 2019. Recruitment has been conducted via social media, web-based communities, and physician referrals. To date, 52 participants have been recruited to the e-CBT group, and 48 patients have been recruited to the in-person CBT group. Data collection is expected to be completed by March 2021, and analyses are expected to be completed by June 2021, as linear regression (for continuous outcomes) and binomial regression analysis (for categorical outcomes) are still being conducted.

Conclusions
The results of this study can provide valuable information for the development of more accessible and scalable mental health interventions with increased care capacity for MDD, without sacrificing the quality of care.

Trial Registration
ClinicalTrials.gov NCT04478058; http://clinicaltrials.gov/ct2/show/NCT04478058

International Registered Report Identifier (IRRID)
DERR1-10.2196/27489