ImportanceTranscranial 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.ObjectiveTo 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 ParticipantsThis 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’ homes and at Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São 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.InterventionstDCS 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 MeasuresChange in HDRS-17 score at week 6.ResultsOf 837 volunteers screened, 210 participants were enrolled (180 [86%] female; mean [SD] age, 38.9 [9.3] years) and allocated to double active (n = 64), tDCS only (n = 73), or double sham (n = 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, −0.48 to 0.58; P = .86), double active vs double sham (Cohen d, −0.20; 95% CI, −0.73 to 0.34; P = .47), and tDCS only vs double sham (Cohen d, −0.25; 95% CI, −0.76 to 0.27; P = .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 RelevanceUnsupervised 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 RegistrationClinicalTrials.gov Identifier: NCT04889976

中文翻译：

---

家用经颅直流电刺激治疗重度抑郁发作

重要性经训练有素的工作人员应用经颅直流电刺激 (tDCS) 对抑郁症有一定效果。目前尚不清楚自我应用的 tDCS 与数字心理干预相结合是否也有效。 目的确定完全无监督的家庭使用 tDCS 与数字心理干预或数字安慰剂相结合是否对重度抑郁发作有效设计、设置和参与者这是一项双盲、假对照、随机临床试验，有 3 个组：(1) 家用 tDCS 加上数字心理干预（双主动）；(2) 家用 tDCS 加数字安慰剂（仅 tDCS），以及 (3) 假家庭用 tDCS 加数字安慰剂（双假）。该研究于 2021 年 4 月至 2022 年 10 月期间在参与者家中和巴西圣保罗大学医学院临床研究所进行。纳入的参与者年龄在 18 至 59 岁之间，患有重度抑郁症，使用汉密尔顿抑郁评定量表，17 项版本 (HDRS-17)，分数高于 16，至少受过 8 年教育，并且在家可以使用智能手机和互联网。排除标准是除焦虑之外的其他精神疾病；神经系统或临床疾病；干预stDCS 连续 15 个工作日以 2-mA、30 分钟的前额叶疗程进行（假手术为 1-mA、持续 90 秒），每周两次，持续 3 周。数字干预包括 46 个基于行为疗法的疗程。数字安慰剂是互联网浏览。主要结果和措施第 6 周 HDRS-17 评分的变化。结果在筛选的 837 名志愿者中，招募了 210 名参与者（180 [86%] 女性；平均 [SD] 年龄，38.9 [9.3] 岁）并分配双重活性 (n = 64)、仅 tDCS (n = 73) 或双重假手术 (n = 73)。在 210 名参与者中，199 名完成了试验。线性混合效应模型没有揭示在 HDRS-17 评分的时间交互作用下治疗中具有统计学显着性的组间差异，组间的估计效应大小如下：双活性与仅 tDCS（Cohend, 0.05; 95% CI，-0.48 至 0.58；磷= .86)，双活性 vs 双假 (Cohend，−0.20；95% CI，-0.73 至 0.34；磷= .47)，以及仅 tDCS 与双重假手术 (Cohend，-0.25；95% CI，-0.76 至 0.27；磷= .35）。在双活性组和仅 tDCS 组中，皮肤发红、发热或烧灼感更常见。仅 tDCS 组发生了 1 例非致命性自杀企图。结论和相关性在本试验中，未发现无监督的家用 tDCS 与数字心理干预或数字安慰剂相结合治疗重度抑郁发作优于假手术。试验注册ClinicalTrials.gov标识符：NCT04889976