Home-based transcranial direct current stimulation combined with behavioral therapy delivered through smartphone to treat major depressive disorder: a randomized, double-blind placebo-controlled trial

Abstract Major depressive disorder (MDD) is the leading cause of disability worldwide. First-line treatments, antidepressants, and cognitive behavioral therapy (CBT), have significant side effects and limited availability, respectively. Transcranial direct current stimulation (tDCS) has been studied in the last two decades as a therapeutic alternative for MDD. tDCS demonstrates good efficacy, safety and tolerability, both as monotherapy and associated with antidepressants and/or psychotherapy. tDCS is a simple procedure that can be performed at home with remote supervision and can possibly be enhanced by combining it with self-directed CBT modalities via smartphone applications. We will present data from a randomized, double-blind, placebo-controlled clinical trial aiming to evaluate the efficacy, safety, tolerability and usability of home-based tDCS combined with behavioral therapy (BT) delivered through smartphone. The study includes 3 arms: (1) active tDCS + active BT, (2) active tDCS + placebo BT and (3) sham-tDCS + placebo BT. Twenty-one sessions of home-based tDCS + BT will be applied, for 6 weeks, ,in patients between 18-59 years, diagnosed with MDD, without contraindications for tDCS, with a smartphone for personal use and internet access at home. Participants are not asked to washout of antidepressant to enter the study. The active tDCS protocol will include daily tDCS sessions at 2mA, for 30 minutes, with the anode and cathode positioned over the left and right prefrontal cortex, respectively. The Flow (Flow Neuroscience, Malmö, Sweden) tDCS equipment and BT application will be used. The results of this study will contribute to the development of home-based tDCS systems, offering a better understanding of the combined effects of tDCS with potentiating strategies (e.g. BT), known to modulate the functioning of key areas in the neurobiology of MDD, such as the dorsolateral prefrontal cortex. Research Category and Technology and Methods Clinical Research: 9. Transcranial Direct Current Stimulation (tDCS) Keywords: tDCS, Home-based, RCT, Behavioral Therapy