JMIR Publications

ABSTRACT

Background:

Major depression is a severe, disabling, and potentially lethal clinical disorder. only about half of the patients respond to an initial course of antidepressant pharmacotherapy. At least 15% of all patients with major depressive disorder remain refractory to any treatment intervention. By the time that a patient had experienced 3 definitive treatment failures, the likelihood of achieving remission with the fourth treatment option offered fell below 10%. These facts underline the clinical urgency for physicians to identify treatment-resistant patients as early as possible so that alternative treatments with proven efficacies may be offered sooner.

Objective:

This study will evaluate the initial comparative clinical effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS) with and without Internet Delivered Cognitive Behavior Therapy (iCBT) as an innovative patient-centred intervention for the treatment of participants diagnosed with treatment-resistant depression (TRD).

Methods:

This study is a prospective, two-arm randomized controlled trial. 100 participants diagnosed with resistant depression in psychiatric care clinic in Edmonton, Alberta, Canada will be randomized to one of two conditions: (1) enrolment in rTMS sessions alone (2) enrolment in the rTMS sessions plus iCBT. Participants in each group will complete evaluation measures (e.g., recovery, general symptomatology and functional outcomes) at baseline, 1 month, 3 months and 6 months. The primary outcome measure would be the mean changed to scores on the Hamilton Depression Rating Scale. Patient service utilization data and clinician-rated measures will also be used to gauge patient progress. Patient data will be analyzed with descriptive statistics, repeated measures and correlational analyses.

Results:

We hypothesize that participants enrolled in the study who will receive rTMS plus iCBT will achieve superior outcomes in comparison to participants who receive rTMS alone.

Conclusions:

The concomitant application of psychotherapy with rTMS has not been investigated previously. We hope that this project will provide us with a concrete base of data to evaluate the practical application and efficacy of using a novel combination of these two treatment modalities (rTMS plus iCBT). Clinical Trial: Trial registration number on ClinicalTrials.gov: NCT04239651