Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode: A Randomized Clinical Trial.

Importance: 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: 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: 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' 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. Interventions: 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: Change in HDRS-17 score at week 6. Results: 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 = 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 Relevance: 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: ClinicalTrials.gov Identifier: NCT04889976.

Trajectories of common mental disorders symptoms before and during the COVID-19 pandemic: findings from the ELSA-Brasil COVID-19 Mental Health Cohort.

AIM: Evidence indicates most people were resilient to the impact of the COVID-19 pandemic on mental health. However, evidence also suggests the pandemic effect on mental health may be heterogeneous. Therefore, we aimed to identify groups of trajectories of common mental disorders' (CMD) symptoms assessed before (2017-19) and during the COVID-19 pandemic (2020-2021), and to investigate predictors of trajectories. METHODS: We assessed 2,705 participants of the ELSA-Brasil COVID-19 Mental Health Cohort study who reported Clinical Interview Scheduled-Revised (CIS-R) data in 2017-19 and Depression Anxiety Stress Scale-21 (DASS-21) data in May-July 2020, July-September 2020, October-December 2020, and April-June 2021. We used an equi-percentile approach to link the CIS-R total score in 2017-19 with the DASS-21 total score. Group-based trajectory modeling was used to identify CMD trajectories and adjusted multinomial logistic regression was used to investigate predictors of trajectories. RESULTS: Six groups of CMD symptoms trajectories were identified: low symptoms (17.6%), low-decreasing symptoms (13.7%), low-increasing symptoms (23.9%), moderate-decreasing symptoms (16.8%), low-increasing symptoms (23.3%), severe-decreasing symptoms (4.7%). The severe-decreasing trajectory was characterized by age < 60 years, female sex, low family income, sedentary behavior, previous mental disorders, and the experience of adverse events in life. LIMITATIONS: Pre-pandemic characteristics were associated with lack of response to assessments. Our occupational cohort sample is not representative. CONCLUSION: More than half of the sample presented low levels of CMD symptoms. Predictors of trajectories could be used to detect individuals at-risk for presenting CMD symptoms in the context of global adverse events.

A study protocol for an ongoing multi-arm, randomized, double-blind, sham-controlled clinical trial with digital features, using portable transcranial electrical stimulation and internet-based behavioral therapy for major depression disorders: The PSYLECT study.

BACKGROUND: Transcranial electrical stimulation (tES) is considered effective and safe for depression, albeit modestly, and prone to logistical burdens when performed in external facilities. Investigation of portable tES (ptES), and potentiation of ptES with remote psychological interventions have shown positive, but preliminary, results. RESEARCH DESIGN: We report the rationale and design of an ongoing multi-arm, randomized, double-blind, sham-controlled clinical trial with digital features, using ptES and internet-based behavioral therapy (iBT) for major depressive disorder (MDD) (NCT04889976). METHODS: We will evaluate the efficacy, safety, tolerability and usability of (1) active ptES + active iBT ('double-active'), (2) active ptES + sham iBT ('ptES-only'), and (3) sham ptES + sham iBT ('double-sham'), in adults with MDD, with a Hamilton Depression Rating Scale - 17 item version (HDRS-17) score ≥ 17 at baseline, during 6 weeks. Antidepressants are allowed in stable doses during the trial. RESULTS: We primarily co-hypothesize changes in HDRS-17 will be greater in (1) 'double-active' compared to 'ptES-only,' (2) 'double-active' compared to 'double-sham,' and (3) 'ptES-only' compared to 'double-sham.' We aim to enroll 210 patients (70 per arm). CONCLUSIONS: Our results should offer new insights regarding the efficacy and scalability of combined ptES and iBT for MDD, in digital mental health.