Examining the synergistic effects of a cognitive control video game and a home-based, self-administered non-invasive brain stimulation on alleviating depression: the DiSCoVeR trial protocol.
Eur Arch Psychiatry Clin Neurosci
; 273(1): 85-98, 2023 Feb.
Article
en En
| MEDLINE
| ID: mdl-36271928
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.
Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Trastorno Depresivo Mayor
/
Estimulación Transcraneal de Corriente Directa
Tipo de estudio:
Clinical_trials
/
Guideline
Límite:
Humans
Idioma:
En
Revista:
Eur Arch Psychiatry Clin Neurosci
Asunto de la revista:
NEUROLOGIA
/
PSIQUIATRIA
Año:
2023
Tipo del documento:
Article
País de afiliación:
Alemania