JMIR Publications

ABSTRACT

Background:

Mental health disorders are a very expensive chronic health problem and depression is the most prevalent cause of disability worldwide. Cognitive Behavioral Therapy (CBT) is a well validated treatment for depression, but despite demonstrated efficacy, it frequently cannot be accessed due to the limitations of face-to-face delivery. In recent years, CBT has been integrated with mindfulness meditation (CBT-M) following strong evidence for increased combined efficacy. Previous studies have demonstrated that online CBT-M is effective in depressive symptom reduction, but direct comparisons to in-office, standard care CBT are needed to precisely assess cost and treatment outcomes.

Objective:

To assess whether online CBT-M plus standard psychiatric care is non-inferior in efficacy and cost-effectiveness to office-based, on-site group CBT-M (plus standard psychiatric care). Outcomes will be compared at post-intervention and 6-month follow up in adults diagnosed with major depressive disorder (MDD). The study will assess whether digitally recorded adherence data predict symptom reductions in the online-intervention participants.

Methods:

This single-centre, 2-arm non-inferiority RCT will employ assessor-blinded and self-report outcome measures and will include a full economic evaluation. The research site is the Centre for Addiction and Mental Health (CAMH), a large psychiatric research institution in Toronto, Canada. Participants will be identified from wait-lists for CAMH services and through contacts with other Toronto outpatient clinics. Inclusion criteria: (1) 18-60 yrs. of any ethnicity; (2) Beck Depression Inventory-II of at least mild severity (BDI-II score ≥ 14) with no upper severity limit; (3) MINI-confirmed diagnosis of MDD; (4) fluent in English. All patients are diagnosed by a CAMH staff psychiatrist with diagnosis confirmed via MINI International Neuropsychiatric Interview administered at the screening visit. Exclusion Criteria: (1) Current receipt of weekly structured psychotherapy outside of trial; (2) individuals who meet DSM-V criteria for severe alcohol/substance use disorder (in the past 3 months), borderline personality disorder, schizophrenia or other primary psychotic disorder, bipolar disorder or obsessive-compulsive disorder; (3) clinically significant suicidal ideation defined as imminent intent or attempted suicide (in the past 6 months); (4) treatment resistant depression (TRD), i.e. failure in at least two trials of antidepressant medications and/or a course of psychotherapy during a current depressive episode.

Results:

Outcomes will be assessed using the Beck Depression Inventory-II (BDI-II)(primary outcome) Secondary outcomes: Anxiety (Beck Anxiety Inventory)39, depression (i.e., Quick Inventory of Depressive Symptomatology; (QIDS)and the 24-item Hamilton Depression Rating Scale (HDRS-24), mindfulness (Five-Facet Mindfulness Questionnaire), quality of life (Euro Qol-5D), patient's personal costs (Health Care Cost Diary for Major Depression) and pain (Brief Pain Inventory. Based on 80% power to reject a hypothesis of inferiority of the on-line CBT-M (compared to the in-office CBT-M), with a one-sided type I error rate of 5%, we calculate a sample size of 78 per group is adequate to detect a small to medium effect size. To allow for a drop-out rate of 20%, we will recruit 100 participants per group (N = 200 total).

Conclusions:

Given sample size, measurements and comparisons (online CBT-M and office-based group CBT), this trial is intended to definitively assess online CBT-M efficacy and establish non-inferiority to office-based group CBT. Clinical Trial: NCT04825535