Portable Transcranial Electrical Stimulation and Internet-Based Behavioral Therapy for Major Depression Study

NACompletedINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

May 22, 2021

Primary Completion Date

October 21, 2022

Study Completion Date

October 21, 2022

Conditions
Major Depressive DisorderUnipolar Depression
Interventions
DEVICE

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).

DEVICE

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).

DEVICE

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).

Trial Locations (2)

Unknown

Institute of Psychiatry, HC-FMUSP, São Paulo

05508000

Hospital Universitário - USP, São Paulo

All Listed Sponsors
collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

lead

University of Sao Paulo

OTHER