Determining the Efficacy of Online Cognitive Behavioural Therapy for Generalized Anxiety Disorder Compared to Pharmaceutical Interventions

Methodology Research Design. This study has been designed using a quasi-experimental design to allow patients the freedom to choose which treatment modality they would like to participate in. This research design aims to be naturalistic by mimicking the decisions made by patients and physicians regarding course of treatment and type of pharmacotherapy prescribed within mental health services across Ontario. The treatments provided within the study also aim to replicate evidence-based best practice clinical guidelines for treatment of GAD.

Research Participants. Patients will be referred to the study by primary care physicians within Toronto and Kingston, Ontario. Patients will be referred to the Anxiety Outpatient Clinic at the Hotel Dieu Hospital site of Kingston Health Sciences Centre or the Mood and Anxiety Clinic within the Centre for Addiction and Mental Health (both sites herein referred to as "the clinic"). Upon receiving a referral to the clinic, participants will be contacted by the study's Research Coordinator and asked to indicate their interest (or lack thereof) in the study. If interest is indicated and the study's inclusion criteria are met, the patient will have a study intake appointment scheduled for the same day as their intake appointment at the clinic. To be considered for inclusion within the study, patients must:

• be 18 years of age or older
• have consistent and reliable access to the internet
• be diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) by a clinician
• meet the criteria for GAD according to the GAD-7 Screener (GAD-7)
• Be competent to consent to participate
• Speak and read English Patients will be deemed ineligible for participation in the study if they are in acute distress.

Allocation of Subjects between Arms of the Study. Subjects will be presented with all three arms of the study within their study intake appointment by the Research Coordinator. After obtaining informed consent, patients will meet with one of the study's psychiatrists during their clinic intake appointment and discuss the recommended treatment plan. In collaboration with the psychiatrist, patients will decide whether or not they would like to begin pharmacotherapy and/or e-CBT treatment.

Criteria for Discontinuation. Patients' participation in the study will be discontinued if they are found to be noncompliant to their treatment. This will be defined as stopping medications all together or reportedly skipping more than two days in a row of medication. Patients will be found noncompliant with e-CBT treatment if they miss more than two weeks of e-CBT sessions or fail to complete weekly homework assignments. Patients' participation within the study will also be halted if they are deemed to be in acute crisis by self-report or the psychiatrist in charge of their care.