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.

Desenvolvimento e propriedades psicométricas da Escala de Pensamentos Depressivos - EPD / Development and psychometric properties of Depressive Thoughts Scale - EPD

Os pensamentos são considerados pela Terapia Cognitiva como parte fundamental para o tratamento da depressão, e pressupõe que a percepção negativa que o sujeito tem de si, dos outros e do futuro interfere diretamente em sua vulnerabilidade cognitiva. Assim, esse estudo objetiva apresentar a construção, avaliação de conteúdo e análise fatorial da Escala de Pensamentos Depressivos - EPD, elaborada segundo a tríade cognitiva. Participaram do estudo inicial 639 sujeitos com e sem diagnóstico confirmado de depressão, com idades entre 18 e 50 anos, de ambos os sexos. As aplicações foram realizadas individualmente para aqueles com diagnóstico, e coletiva para os demais. Verificou-se que os itens da EPD diferenciaram os grupos, apontando os com diagnóstico de depressão como aqueles com maiores distorções de pensamento. Após a análise fatorial, a escala foi reduzida a 34 itens, com cinco fatores interpretáveis e não aleatórios, sendo eles nomeados como Baixa autoestima/desvalorização, Relacionamento interpessoal, Auto-valorização, Expectativas negativas/insatisfação e Desajustamento social. Os índices de fidedignidade demonstraram que há a necessidade de outros estudos na configuração da escala. Tais resultados indicam qualidades psicométricas promissoras para a escala, e servem ao intuito de suscitar novos estudos para buscar evidências de validade e precisão(AU)

Thoughts are considered by Cognitive Therapy as an essential part for depression treatment and consider that the negative perception of yourself, the others and future interfere directly in their cognitive vulnerability. This way, the present study aims to present the item construction process, content evaluation and factor analysis of the Depressive Thoughts Scale - EPD, based on cognitive triad. Participated of the study 639 subjects with and without depression diagnosis, aged 18 to 50 of both sexes. Applications were performed individually for those with confirmed diagnostic of depression and collectively for others. It was found that EPD items were able to differentiate the groups, indicating those diagnosed with depression as those with higher depression thoughts. After factor analysis, scale was reduced to 34 items, with five interpretable factors and not randomized, named as Low self esteem, Interpersonal relationship, Self appreciation, Negative expectations and Disarrangement social and dissatisfaction. The reability indices pointed the need for further studies in order to investigate the scale configuration. These results indicate adequate psychometric properties for the scale, and serve the purpose of arousing further studies to find evidence of validity and reliability(AU)