ABSTRACT
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.
Subject(s)
Depressive Disorder, Major , Transcranial Direct Current Stimulation , Humans , Depressive Disorder, Major/therapy , Transcranial Direct Current Stimulation/methods , Depression/therapy , Quality of Life , Treatment Outcome , Double-Blind Method , Cognition , Brain , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
In modern societies, training reading skills is fundamental since poor-reading children are at high risk of struggling both at school and in life. Reading relies not only on oral language abilities but also on several executive functions. Considering their importance for literacy, training executive functions-particularly, attentional control has been suggested as a promising way of improving reading skills. For this reason, we developed a video game-based cognitive intervention aimed at improving several facets of executive functions. This game is composed of mini-games that apply gamified versions of standard clinical exercises linked through a game environment with action video game dynamics. Here, in a study involving 151 typically reading children, we demonstrated that after this general-domain behavioural intervention reading abilities, as well as attentional and planning skills, were significantly improved. Our results showed that training attentional control can translate into better reading efficiency, maintained at a follow-up test 6 months later.
