210
Participants
Start Date
May 22, 2021
Primary Completion Date
October 21, 2022
Study Completion Date
October 21, 2022
Double Active: Active portable transcranial stimulation (ptES) and active internet-based behavioral therapy (iBT)
ptES is delivered by the Flow device (Flow Neuroscience, Malmö, Sweden), consisting of a one-size-fits-all, transcranial direct current stimulation (tDCS) headset with circular electrodes (area = 22.9cm2). The anode is positioned over the left prefrontal cortex, and the cathode over the right prefrontal cortex. Current strength is set at 2mA (current density = 0.087mA/cm2) for 30 minutes, daily for 5 continuous days (with a 2-day pause) for the first 3 weeks, with twice-weekly sessions for the following 3 weeks (total of 21 sessions in 6 weeks). Active iBT consists of a smartphone app with an electronic therapist-avatar. The iBT sessions are delivered concomitantly to the tDCS sessions (the tDCS device connects via bluetooth to the participant's smartphone app).
ptES-only: Active portable transcranial stimulation (ptES) and sham internet-based behavioral therapy (iBT)
ptES is delivered by the Flow device (Flow Neuroscience, Malmö, Sweden), consisting of a one-size-fits-all, transcranial direct current stimulation (tDCS) headset with circular electrodes (area = 22.9cm2). The anode is positioned over the left prefrontal cortex, and the cathode over the right prefrontal cortex. Current strength is set at 2mA (current density = 0.087mA/cm2) for 30 minutes, daily for 5 continuous days (with a 2-day pause) for the first 3 weeks, with twice-weekly sessions for the following 3 weeks (total of 21 sessions in 6 weeks). The sham iBT sessions are delivered concomitantly to the active ptES sessions (the ptES device connects via bluetooth to the participant's smartphone app).
Double-sham: Sham portable transcranial stimulation (ptES) and sham internet-based behavioral therapy (iBT)
Sham ptES for this trial is delivered by the Flow device (Flow Neuroscience, Malmö, Sweden), consisting of a one-size-fits-all transcranial direct current stimulation (tDCS) headset, with circular electrodes (area = 22.9cm2). The anode is positioned over the left prefrontal cortex, and the cathode over the right prefrontal cortex. The sham protocol consists of a fade-in and fade-out phases of 1mA for 45 seconds, followed by a silent period in between for the remaining 28 1/2 minutes. The sham iBT sessions are delivered concomitantly to the sham ptES sessions (the ptES device connects via bluetooth to the participant's smartphone app).
Institute of Psychiatry, HC-FMUSP, São Paulo
Hospital Universitário - USP, São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo
OTHER