Efficacy of Online CBT for GAD Compared to Pharmaceutical Interventions

Summary

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

Conditions

• Generalized Anxiety Disorder

Interventions

DRUG

SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)

If never taken SSRI or SNRI, commence primary medication arm (SSRI: sertraline, escitalopram or Pregabalin/SNRI: duloxetine, venlafaxine) will be described to patient and will begin either. If deemed unresponsive to either prior to study, commence medication they have not been previously unresponsive to. Unresponsive if GAD did not improve after treatment with maximum tolerated dose for 8-weeks. If deemed unresponsive to SSRI and SNRI/pregabalin, commence secondary medication arm (bupropion/mirtazepine, buspirone/imipramine) with both being described to patient and begin either. Switch protocol: If unresponsive after 4 or 6 weeks, switch to another class. If started in primary or secondary and not previously demonstrated non-response to second class of medications within arm, switch to second class within arm. If started in primary and previously deemed unresponsive to second class, begin secondary if non-response indicates switch necessary.

BEHAVIORAL

Electronic Cognitive Behavioural Therapy

Weekly sessions of e-CBT through OPTT will consist of approximately 30 slides. Each session is expected to last approximately 50 minutes. The content and format of each weekly online session was designed to mirror live CBT. The slides will highlight a different topic each week and include general information, an overview of skills and homework on that topic. The homework included in each session will be submitted through OPTT and reviewed by the clinicians with personalized feedback provided by clinicians within three days of submission. Weekly homework submission for feedback will be mandatory before being eligible for the next session. Biweekly GAD-7, DASS-42 and Q-LES-SF questionnaires will be completed through OPTT. A second STAI will be completed in the final week of e-CBT treatment.

Sponsors & Collaborators

• Online PsychoTherapy Clinic

  collaborator OTHER

• Dr. Nazanin Alavi

  lead OTHER

Principal Investigators

• Nazanin Alavi · Queen's University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-29

Primary Completion

2021-05-01

Completion

2021-05-01

Countries

• Canada

Study Locations