دورية أكاديمية
Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode: A Randomized Clinical Trial.
| العنوان: | Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode: A Randomized Clinical Trial. |
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| المؤلفون: | Borrione L; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Cavendish BA; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Aparicio LVM; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Luethi MS; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Goerigk S; Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilian University of Munich, Munich, Germany.; Charlotte Fresenius Hochschule, Munich, Germany., Ramos MRF; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Moran NKS; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Carneiro AM; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Valiengo L; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Moura DO; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., de Souza JP; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Batista MP; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Aparecida da Silva V; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Klein I; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Suen P; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Gallucci-Neto J; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil., Padberg F; Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilian University of Munich, Munich, Germany., Razza LB; Department of Head and Skin, Psychiatry and Medical Psychology, Ghent University Hospital, Ghent University, Ghent, Belgium.; Ghent Experimental Psychiatry Laboratory, Ghent, Belgium., Vanderhasselt MA; Department of Head and Skin, Psychiatry and Medical Psychology, Ghent University Hospital, Ghent University, Ghent, Belgium.; Ghent Experimental Psychiatry Laboratory, Ghent, Belgium., Lotufo PA; Department of Internal Medicine, University of São Paulo Medical School, São Paulo, Brazil.; Center for Clinical and Epidemiological Research, Hospital Universitário, University of São Paulo, São Paulo, Brazil., Bensenor IM; Department of Internal Medicine, University of São Paulo Medical School, São Paulo, Brazil.; Center for Clinical and Epidemiological Research, Hospital Universitário, University of São Paulo, São Paulo, Brazil., Fregni F; Laboratory of Neuromodulation and Center for Clinical Research Learning, Physics, and Rehabilitation Department, Spaulding Rehabilitation Hospital, Boston, Massachusetts., Brunoni AR; Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Laboratory of Neuroscience and National Institute of Biomarkers in Psychiatry, Department and Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.; Department of Internal Medicine, University of São Paulo Medical School, São Paulo, Brazil.; Center for Clinical and Epidemiological Research, Hospital Universitário, University of São Paulo, São Paulo, Brazil. |
| المصدر: | JAMA psychiatry [JAMA Psychiatry] 2024 Apr 01; Vol. 81 (4), pp. 329-337. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 101589550 Publication Model: Print Cited Medium: Internet ISSN: 2168-6238 (Electronic) Linking ISSN: 2168622X NLM ISO Abbreviation: JAMA Psychiatry Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago, IL : American Medical Association, [2013]- |
| مواضيع طبية MeSH: | Transcranial Direct Current Stimulation* , Depressive Disorder, Major*/drug therapy, Humans ; Female ; Adult ; Male ; Treatment Outcome ; Double-Blind Method ; Brazil |
| مستخلص: | 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. |
| التعليقات: | Erratum in: JAMA Psychiatry. 2024 Apr 1;81(4):428. (PMID: 38568242) |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04889976 |
| تواريخ الأحداث: | Date Created: 20240103 Date Completed: 20240404 Latest Revision: 20240404 |
| رمز التحديث: | 20240404 |
| مُعرف محوري في PubMed: | PMC10765312 |
| DOI: | 10.1001/jamapsychiatry.2023.4948 |
| PMID: | 38170541 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2168-6238 |
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| DOI: | 10.1001/jamapsychiatry.2023.4948 |