Key PointsQuestion听
What is the efficacy of fully unsupervised home-use transcranial direct current stimulation (tDCS) combined with either a digital psychological intervention or digital placebo for the treatment of a major depressive episode?
Findings听
In this randomized clinical trial including 210 adults with a major depressive episode, no statistically significant differences were detected between home-use tDCS combined with either a digital psychological intervention or digital placebo vs sham in reducing depressive symptoms after 6 weeks.
Meaning听
The findings indicate that unsupervised home use tDCS should not be currently recommended in clinical practice.
Importance听
Transcranial direct current stimulation (tDCS) is moderately effective for depression when applied by trained staff. It is not known whether self-applied tDCS, combined or not with a digital psychological intervention, is also effective.
Objective听
To determine whether fully unsupervised home-use tDCS, combined with a digital psychological intervention or digital placebo, is effective for a major depressive episode.
Design, Setting, and Participants听
This was a double-blinded, sham-controlled, randomized clinical trial with 3 arms: (1) home-use tDCS plus a digital psychological intervention (double active); (2) home-use tDCS plus digital placebo (tDCS only), and (3) sham home-use tDCS plus digital placebo (double sham). The study was conducted between April 2021 and October 2022 at participants鈥� homes and at Instituto de Psiquiatria do Hospital das Cl铆nicas da Faculdade de Medicina da Universidade de S茫o Paulo, Brazil. Included participants were aged 18 to 59 years with major depression and a Hamilton Depression Rating Scale, 17-item version (HDRS-17), score above 16, a minimum of 8 years of education, and access to a smartphone and internet at home. Exclusion criteria were other psychiatric disorders, except for anxiety; neurologic or clinical disorders; and tDCS contraindications.
Interventions听
tDCS was administered in 2-mA, 30-minute prefrontal sessions for 15 consecutive weekdays (1-mA, 90-second duration for sham) and twice-weekly sessions for 3 weeks. The digital intervention consisted of 46 sessions based on behavioral therapy. Digital placebo was internet browsing.
Main Outcomes and Measures听
Change in HDRS-17 score at week 6.
Results听
Of 837 volunteers screened, 210 participants were enrolled (180 [86%] female; mean [SD] age, 38.9 [9.3] years) and allocated to double active (n鈥�=鈥�64), tDCS only (n鈥�=鈥�73), or double sham (n鈥�=鈥�73). Of the 210 participants enrolled, 199 finished the trial. Linear mixed-effects models did not reveal statistically significant group differences in treatment by time interactions for HDRS-17 scores, and the estimated effect sizes between groups were as follows: double active vs tDCS only (Cohen d, 0.05; 95% CI, 鈭�0.48 to 0.58; P鈥�=鈥�.86), double active vs double sham (Cohen d, 鈭�0.20; 95% CI, 鈭�0.73 to 0.34; P鈥�=鈥�.47), and tDCS only vs double sham (Cohen d, 鈭�0.25; 95% CI, 鈭�0.76 to 0.27; P鈥�=鈥�.35). Skin redness and heat or burning sensations were more frequent in the double active and tDCS only groups. One nonfatal suicide attempt occurred in the tDCS only group.
Conclusions and Relevance听
Unsupervised home-use tDCS combined with a digital psychological intervention or digital placebo was not found to be superior to sham for treatment of a major depressive episode in this trial.
Trial Registration听
ClinicalTrials.gov Identifier: