TY  - JOUR
AU  - Alavi, Nazanin
AU  - Stephenson, Callum
AU  - Yang, Megan
AU  - Shirazi, Amirhossein
AU  - Shao, Yijia
AU  - Kumar, Anchan
AU  - Yee, Caitlin S
AU  - Miller, Shadé
AU  - Stefatos, Anthi
AU  - Gholamzadehmir, Maedeh
AU  - Abbaspour, Zara
AU  - Patel, Archana
AU  - Patel, Charmy
AU  - Reshetukha, Taras
AU  - Omrani, Mohsen
AU  - Groll, Dianne
PY  - 2021
DA  - 2021/5/27
TI  - Determining the Efficacy of Electronic Cognitive Behavioral Therapy for Generalized Anxiety Disorder Compared to Pharmaceutical Interventions: Protocol for a Quasi-Experimental Study
JO  - JMIR Res Protoc
SP  - e27772
VL  - 10
IS  - 5
KW  - eHealth
KW  - mental health
KW  - anxiety
KW  - generalized anxiety disorder
KW  - cognitive behavioral therapy
KW  - psychotherapy
KW  - online
KW  - internet
KW  - electronic
KW  - virtual
KW  - mental health care
AB  - 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://clinicaltrials.gov/ct2/show/NCT04478526 International Registered Report Identifier (IRRID): DERR1-10.2196/27772 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2021/5/e27772
UR  - https://doi.org/10.2196/27772
UR  - http://www.ncbi.nlm.nih.gov/pubmed/33857917
DO  - 10.2196/27772
ID  - info:doi/10.2196/27772
ER  -