Determining the Efficacy of Electronic Cognitive Behavioral Therapy for Generalized Anxiety Disorder Compared to Pharmaceutical Interventions: Protocol for a Quasi-Experimental Study

Nazanin Alavi, Callum Stephenson, Megan Yang, Amirhossein Shirazi, Yijia Shao, Anchan Kumar, Caitlin S Yee, Shadé Miller, Anthi Stefatos, Maedeh Gholamzadehmir, Zara Abbaspour, Archana Patel, Charmy Patel, Taras Reshetukha, Mohsen Omrani, Dianne Groll, Nazanin Alavi, Callum Stephenson, Megan Yang, Amirhossein Shirazi, Yijia Shao, Anchan Kumar, Caitlin S Yee, Shadé Miller, Anthi Stefatos, Maedeh Gholamzadehmir, Zara Abbaspour, Archana Patel, Charmy Patel, Taras Reshetukha, Mohsen Omrani, Dianne Groll

Abstract

Background: Generalized anxiety disorder (GAD) is an extremely prevalent and debilitating mental health disorder. Currently, the gold standard treatment for GAD is cognitive behavioral therapy (CBT) and/or pharmacotherapy. The most common medications used to treat GAD are selective serotonin reuptake inhibitors and selective norepinephrine reuptake inhibitors. While CBT is the gold standard treatment for GAD, it is costly, time-consuming, and often inaccessible. Fortunately, the electronic delivery of CBT (e-CBT) has emerged as a promising solution to address these barriers. e-CBT has shown to offer comparable results to in-person CBT while improving accessibility for patients and time efficiency for clinicians.

Objective: This study aims to investigate the treatment efficacy of e-CBT compared to and in conjunction with pharmacotherapy for GAD.

Methods: This study will use a quasi-experimental design to allow patients the freedom to choose which treatment modality they would like to receive. Participants with a diagnosis of GAD will be enrolled in 1 of 3 possible treatment arms: (1) e-CBT, (2) medication, or (3) a combination of e-CBT and medication. The e-CBT program will include a 12-week psychotherapy program delivered through the Online Psychotherapy Tool-a secure, cloud-based, digital mental health platform. The treatment efficacy of e-CBT will be compared with that of medication alone and medication in combination with e-CBT.

Results: The study received ethics approval in April 2019 and participant recruitment began in June 2019. Participant recruitment has been conducted through social media advertisements, physical advertisements, and physician referrals. To date, 146 participants (e-CBT: n=53; medication: n=49; combination: n=44) have been recruited. Data collection is expected to conclude by June 2021, and data analysis is expected to be completed by October 2021. Linear regression (for continuous outcomes) and binomial regression (for categorical outcomes) analysis will be conducted using interpretive qualitative methods.

Conclusions: If either the efficacy of e-CBT is shown to be comparable to that of medication or the effects of both treatments are augmented when used in tandem, these findings could have major implications on the mental health care system. e-CBT is a more accessible and affordable treatment that could increase mental health care capacity 4-fold if proven viable.

Trial registration: ClinicalTrials.gov NCT04478526; https://ichgcp.net/clinical-trials-registry/NCT04478526.

International registered report identifier (irrid): DERR1-10.2196/27772.

Keywords: anxiety; cognitive behavioral therapy; eHealth; electronic; generalized anxiety disorder; internet; mental health; mental health care; online; psychotherapy; virtual.

Conflict of interest statement

Conflicts of Interest: NA and MO have cofounded the care delivery platform in use (ie, OPTT) and have ownership stakes in OPTT Inc.

©Nazanin Alavi, Callum Stephenson, Megan Yang, Amirhossein Shirazi, Yijia Shao, Anchan Kumar, Caitlin S Yee, Shadé Miller, Anthi Stefatos, Maedeh Gholamzadehmir, Zara Abbaspour, Archana Patel, Charmy Patel, Taras Reshetukha, Mohsen Omrani, Dianne Groll. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 27.05.2021.

Figures

Figure 1
Figure 1
Flowchart of the 12-week generalized anxiety disorder pharmacotherapy protocol. SNRI: selective norepinephrine reuptake inhibitor; SSRI: selective serotonin reuptake inhibitor.

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