Repetitive Transcranial Magnetic Stimulation With and Without Internet-Delivered Cognitive-Behavioral Therapy for the Treatment of Resistant Depression: Protocol for Patient-Centered Randomized Controlled Pilot Trial (Preprint)

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). CLINICALTRIAL Trial registration number on ClinicalTrials.gov: NCT04239651