Enhanced behavioral interventions are gaining increasing interest as innovative treatment strategies for major depressive disorder (MDD). In this study protocol, we propose to examine the synergistic effects of a self-administered home-treatment, encompassing transcranial direct current stimulation (tDCS) along with a video game based training of attentional control. The study is designed as a two-arm, double-blind, randomized and placebo-controlled multi-center trial (ClinicalTrials.gov: NCT04953208). At three study sites (Israel, Latvia, and Germany), 114 patients with a primary diagnosis of MDD undergo 6 weeks of intervention (30 × 30 min sessions). Patients assigned to the intervention group receive active tDCS (anode F3 and cathode F4; 2 mA intensity) and an action-like video game, while those assigned to the control group receive sham tDCS along with a control video game. An electrode-positioning algorithm is used to standardize tDCS electrode positioning. Participants perform their designated treatment at the clinical center (sessions 1–5) and continue treatment at home under remote supervision (sessions 6–30). The endpoints are feasibility (primary) and safety, treatment efficacy (secondary, i.e., change of Montgomery-Åsberg Depression Rating Scale (MADRS) scores at week six from baseline, clinical response and remission, measures of social, occupational, and psychological functioning, quality of life, and cognitive control (tertiary). Demonstrating the feasibility, safety, and efficacy of this novel combined intervention could expand the range of available treatments for MDD to neuromodulation enhanced interventions providing cost-effective, easily accessible, and low-risk treatment options. ClinicalTrials.gov: NCT04953208.
|Original language||American English|
|Number of pages||14|
|Journal||European Archives of Psychiatry and Clinical Neuroscience|
|State||Published - Feb 2023|
Bibliographical noteFunding Information:
Open Access funding enabled and organized by Projekt DEAL. The DisCoVeR project is funded by ERA NET NEURON. The NEURON ‘Network of European Funding for Neuroscience Research is established under the organization of the ERA-NET ‘European Research Area Networks’ of the European Commission. National funding agencies are the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]) for LMU Munich, the Ministry of Health (MOH) for HUJI and Hadassah, the Swiss National Science Foundation (SNSF) for UNIGE and EPFL and the State Education and Development Agency (VIAA) of Latvia for RSU.
This project was funded by the European Research Area Network (ERA-NET) NEURON 2018 Mental Disorders program.
© 2022, The Author(s).
- Cognitive control
- Major depressive disorder
- Transcranial direct current stimulation (tDCS)
- Video game