Comparing Online and On-Site Cognitive Behavior Therapy in Major Depressive Disorder: Protocol for a Noninferiority Randomized Controlled Trial

Abstract

Background: The incidence of mental health disorders in Canada is increasing with costs of CAD $51 billion (US $40 billion) per year. Depression is the most prevalent cause of disability while cognitive behavioral therapy (CBT) is the best validated behavioral depression treatment. CBT, when combined with mindfulness meditation (CBT-M), has strong evidence for increased efficacy. While randomized controlled trials (RCTs) have demonstrated online CBT-M efficacy, comparisons with in-office delivery are lacking.

Objective: The aim of this research is to assess whether online group CBT-M (with standard psychiatric care) is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M at post-intervention and 6-months follow-up in major depressive disorder. The study will also assess whether digitally recorded data (ie, online workbooks completed, Fitbit step count, and online text messages) predict depression symptom reduction in online participants.

Methods: This single-center, two-arm, noninferiority RCT employs assessor-blinded and self-report outcomes and economic evaluation. The research site is the Centre for Addiction and Mental Health (Toronto), a research-based psychiatry institution where participants will be identified from service wait lists and through contacts with other Toronto clinics. Inclusion criteria are as follows: (1) aged 18-60 years, any ethnicity; (2) Beck Depression Inventory-II (BDI-II) of mild severity (score ≥14) with no upper severity limit; (3) Mini-International Neuropsychiatric Interview-confirmed, psychiatric major depressive disorder diagnosis; (4) fluent in English. All patients are diagnosed by staff psychiatrists. Exclusion criteria are as follows: (1) receipt of weekly structured psychotherapy; (2) observation of Diagnostic and Statistical Manual of Mental Disorders (5th Edition) criteria for severe alcohol or substance use disorder (in past 3 months), borderline personality disorder, schizophrenia (or other primary psychotic disorder), bipolar disorder, or obsessive-compulsive disorder; (3) clinically significant suicidal ideation (imminent intent or attempted suicide in the past 6 months); and (4) treatment-resistant depression. All participants receive standard psychiatric care, experimental participants receive online group CBT-M, and controls receive standard care in-office group CBT-M. The online group program (in collaboration with NexJ Health, Inc) combines smartphone and computer-accessed workbooks with mental health phone counselling (16 hours in 16 weeks) that coordinates software interactions (eg, secure text messaging and Fitbit-tracked walking). The primary outcome is BDI-II, and secondary outcomes are anxiety (Beck Anxiety Inventory), depression (ie, Quick Inventory of Depressive Symptomatology and 17-item Hamilton Depression Rating Scale), mindfulness (Five-Facet Mindfulness Questionnaire), quality of life (European Quality of Life Five Dimension), and pain (Brief Pain Inventory).

Results: Based on prior studies with the BDI-II and 80% power to reject an inferiority hypothesis with a 1-sided type I error rate of 5%, a sample of 78 per group is adequate to detect small-to-medium-effect sizes.

Conclusions: This study assesses online CBT-M efficacy and noninferiority in relation to in-person CBT, and the cost-effectiveness of both interventions.

Trial registration: ClinicalTrials.gov NCT04825535; https://www.clinicaltrials.gov/ct2/show/NCT04825535.

International registered report identifier (irrid): DERR1-10.2196/29726.

Keywords: major depressive disorder; online intervention; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: NW is an employee of NexJ Health and holds stock in the company. NexJ Health provides in-kind subscriptions for the digital health platform of NexJ Connected Wellness, which enables the delivery of the CBT-M program and provides health coaching to the participants in the CBT-M intervention group. PR receives in-kind software support from NexJ Health for this investigator-initiated study, funded by the Canadian Institutes of Health Research (CIHR). He also receives research support from NexJ Health through the Digital Health Research Fund administered by the Faculty of Health at York University. ZD has received research and equipment in-kind support for an investigator-initiated study through Brainsway Inc and Magventure Inc. He is also on the scientific advisory board for Brainsway Inc. His work has been supported by the National Institutes of Mental Health (NIMH), Canadian Institutes of Health Research (CIHR), Brain Canada, and Temerty Family Foundation, and Grant Family Foundation.

©Paul Ritvo, David Gratzer, Yuliya Knyahnytska, Abigail Ortiz, Clarice Walters, Joel Katz, Judith Laposa, Christopher Baldissera, Noah Wayne, Donna Pfefer-Litman, George Tomlinson, Zafiris Daskalakis. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 08.04.2022.