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

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Citações na Scopus
4
Tipo de produção
article
Data de publicação
2022
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
TAYLOR & FRANCIS LTD
Autores
SOUZA, Juliana P. de
Citação
EXPERT REVIEW OF NEUROTHERAPEUTICS, v.22, n.6, p.513-523, 2022
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
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.
Palavras-chave
Digital mental health, internet-based behavioral therapy, major depressive disorder, portable transcranial direct current stimulation, portable transcranial electrical stimulation
URI
https://observatorio.fm.usp.br/handle/OPI/48256
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Coleções
Artigos e Materiais de Revistas Científicas - FM/MCM
Artigos e Materiais de Revistas Científicas - HC/ICHC
Artigos e Materiais de Revistas Científicas - HC/IPq
Artigos e Materiais de Revistas Científicas - LIM/20
Artigos e Materiais de Revistas Científicas - LIM/27