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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Feb 5, 2021
Date Accepted: Apr 12, 2021
Date Submitted to PubMed: Apr 15, 2021

The final, peer-reviewed published version of this preprint can be found here:

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

Alavi N, Stephenson C, Yang M, Shirazi A, Shao Y, Kumar A, Yee CS, Miller S, Stefatos A, Gholamzadehmir M, Abbaspour Z, Patel A, Patel C, Reshetukha T, Omrani M, Groll D

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

JMIR Res Protoc 2021;10(5):e27772

DOI: 10.2196/27772

PMID: 33857917

PMCID: 8193484

Determining the efficacy of electronic cognitive behavioural therapy for generalized anxiety disorder compared to pharmaceutical interventions: Research protocol

  • 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 behavioural therapy (CBT) and/or pharmacotherapy. The most common medications used to treat GAD are selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors (SNRIs). While CBT is a 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:

The following project aims to investigate the treatment efficacy of e-CBT compared to, and in conjunction with pharmacotherapy for GAD.

Methods:

This study has been designed using 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: e-CBT, medication, or combination. The e-CBT program will include a 12-week psychotherapy program delivered through the Online Psychotherapy Tool (OPTT), a secure, cloud-based, digital mental health platform. The treatment efficacy of e-CBT will be compared to the treatment efficacy of the medication arm and the combination arm.

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, there have been 146 (e-CBT n = 53; Medication n = 49; Combination n = 44) participants recruited. Data collection is expected to conclude by April 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 with interpretive qualitative methods.

Conclusions:

If e-CBT is shown to either be comparable to medication or that 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 by four-folds if proven viable. Clinical Trial: ClinicalTrials.Gov Protocol Registration and Results System (NCT04478526); clinicaltrials.gov/ct2/show/NCT04478526.


 Citation

Please cite as:

Alavi N, Stephenson C, Yang M, Shirazi A, Shao Y, Kumar A, Yee CS, Miller S, Stefatos A, Gholamzadehmir M, Abbaspour Z, Patel A, Patel C, Reshetukha T, Omrani M, Groll D

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

JMIR Res Protoc 2021;10(5):e27772

DOI: 10.2196/27772

PMID: 33857917

PMCID: 8193484

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