Transcranial direct current stimulation as an add-on treatment to cognitive-behavior therapy in first episode drug-naive major depression patients: the ESAP study protocol
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/1822/69945 |
Resumo: | Background: Major Depressive Disorder (MDD) affects more than 264 million people worldwide. Current treatments include the use of psychotherapy and/or drugs, however similar to 30% of patients either do not respond to these treatments, or do not tolerate the side effects associated to the use of pharmacological interventions. Thus, it is important to study non-pharmacological interventions targeting mechanisms not directly involved with the regulation of neurotransmitters. Several studies demonstrated that transcranial Direct Current Stimulation (tDCS) can be effective for symptoms relief in MDD. However, tDCS seems to have a better effect when used as an add-on treatment to other interventions.Methods/Design: This is a study protocol for a parallel, randomized, triple-blind, sham-controlled clinical trial in which a total of 90 drug-naive, first-episode MDD patients (45 per arm) will be randomized to one of two groups to receive a 6-weeks of CBT combined with either active or sham tDCS to the dorsolateral prefrontal cortex (DLPFC). The primary outcome will depressive symptoms improvement as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) at 6-weeks. The secondary aim is to test whether CBT combined with tDCS can engage the proposed mechanistic target of restoring the prefrontal imbalance and connectivity through the bilateral modulation of the DLPFC, as assessed by changes over resting-state and emotional task eliciting EEG.Discussion: This study evaluates the synergetic clinical effects of CBT and tDCS in the first episode, drug-naive, patients with MDD. First episode MDD patients provide an interesting opportunity, as their brains were not changed by the pharmacological treatments, by the time course, or by the recurrence of MDD episodes (and other comorbidities). |
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Transcranial direct current stimulation as an add-on treatment to cognitive-behavior therapy in first episode drug-naive major depression patients: the ESAP study protocolMDD (Major Depressive Disorder)study protocoldrug-naivetDCS (transcranial direct current stimulation)CBT (cognitive-behavioral therapy)drug-naïveCiências Sociais::PsicologiaScience & TechnologyBackground: Major Depressive Disorder (MDD) affects more than 264 million people worldwide. Current treatments include the use of psychotherapy and/or drugs, however similar to 30% of patients either do not respond to these treatments, or do not tolerate the side effects associated to the use of pharmacological interventions. Thus, it is important to study non-pharmacological interventions targeting mechanisms not directly involved with the regulation of neurotransmitters. Several studies demonstrated that transcranial Direct Current Stimulation (tDCS) can be effective for symptoms relief in MDD. However, tDCS seems to have a better effect when used as an add-on treatment to other interventions.Methods/Design: This is a study protocol for a parallel, randomized, triple-blind, sham-controlled clinical trial in which a total of 90 drug-naive, first-episode MDD patients (45 per arm) will be randomized to one of two groups to receive a 6-weeks of CBT combined with either active or sham tDCS to the dorsolateral prefrontal cortex (DLPFC). The primary outcome will depressive symptoms improvement as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) at 6-weeks. The secondary aim is to test whether CBT combined with tDCS can engage the proposed mechanistic target of restoring the prefrontal imbalance and connectivity through the bilateral modulation of the DLPFC, as assessed by changes over resting-state and emotional task eliciting EEG.Discussion: This study evaluates the synergetic clinical effects of CBT and tDCS in the first episode, drug-naive, patients with MDD. First episode MDD patients provide an interesting opportunity, as their brains were not changed by the pharmacological treatments, by the time course, or by the recurrence of MDD episodes (and other comorbidities).This work was partially supported by FEDER funds through the Programa Operacional Factores de Competitividade-COMPETE and by national funds through FCT-Fundacao para a Ciencia e a Tecnologia through the calls IF/00091/2015 and PTDC/PSI-ESP/29701/2017. The sponsors had no role in the study design, implementation, data analysis or publication.Frontiers Media S.A.Universidade do MinhoCarvalho, SandraGonçalves, Óscar F.Brunoni, Andre R.Fernandes-Goncalves, AnaFregni, FelipeLeite, Jorge2020-11-032020-11-03T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/1822/69945engCarvalho, S., Gonçalves, Ó. F., Brunoni, A. R., Fernandes-Gonçalves, A., Fregni, F., & Leite, J. (2020). Transcranial Direct Current Stimulation as an Add-on Treatment to Cognitive-Behavior Therapy in First Episode Drug-Naïve Major Depression Patients: The ESAP Study Protocol. [10.3389/fpsyt.2020.563058]. Frontiers in Psychiatry, 11, 1149. DOI: 10.3389/fpsyt.2020.5630581664-064010.3389/fpsyt.2020.563058https://www.frontiersin.org/articles/10.3389/fpsyt.2020.563058info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-07-21T12:41:37Zoai:repositorium.sdum.uminho.pt:1822/69945Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T19:38:38.392879Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Transcranial direct current stimulation as an add-on treatment to cognitive-behavior therapy in first episode drug-naive major depression patients: the ESAP study protocol |
title |
Transcranial direct current stimulation as an add-on treatment to cognitive-behavior therapy in first episode drug-naive major depression patients: the ESAP study protocol |
spellingShingle |
Transcranial direct current stimulation as an add-on treatment to cognitive-behavior therapy in first episode drug-naive major depression patients: the ESAP study protocol Carvalho, Sandra MDD (Major Depressive Disorder) study protocol drug-naive tDCS (transcranial direct current stimulation) CBT (cognitive-behavioral therapy) drug-naïve Ciências Sociais::Psicologia Science & Technology |
title_short |
Transcranial direct current stimulation as an add-on treatment to cognitive-behavior therapy in first episode drug-naive major depression patients: the ESAP study protocol |
title_full |
Transcranial direct current stimulation as an add-on treatment to cognitive-behavior therapy in first episode drug-naive major depression patients: the ESAP study protocol |
title_fullStr |
Transcranial direct current stimulation as an add-on treatment to cognitive-behavior therapy in first episode drug-naive major depression patients: the ESAP study protocol |
title_full_unstemmed |
Transcranial direct current stimulation as an add-on treatment to cognitive-behavior therapy in first episode drug-naive major depression patients: the ESAP study protocol |
title_sort |
Transcranial direct current stimulation as an add-on treatment to cognitive-behavior therapy in first episode drug-naive major depression patients: the ESAP study protocol |
author |
Carvalho, Sandra |
author_facet |
Carvalho, Sandra Gonçalves, Óscar F. Brunoni, Andre R. Fernandes-Goncalves, Ana Fregni, Felipe Leite, Jorge |
author_role |
author |
author2 |
Gonçalves, Óscar F. Brunoni, Andre R. Fernandes-Goncalves, Ana Fregni, Felipe Leite, Jorge |
author2_role |
author author author author author |
dc.contributor.none.fl_str_mv |
Universidade do Minho |
dc.contributor.author.fl_str_mv |
Carvalho, Sandra Gonçalves, Óscar F. Brunoni, Andre R. Fernandes-Goncalves, Ana Fregni, Felipe Leite, Jorge |
dc.subject.por.fl_str_mv |
MDD (Major Depressive Disorder) study protocol drug-naive tDCS (transcranial direct current stimulation) CBT (cognitive-behavioral therapy) drug-naïve Ciências Sociais::Psicologia Science & Technology |
topic |
MDD (Major Depressive Disorder) study protocol drug-naive tDCS (transcranial direct current stimulation) CBT (cognitive-behavioral therapy) drug-naïve Ciências Sociais::Psicologia Science & Technology |
description |
Background: Major Depressive Disorder (MDD) affects more than 264 million people worldwide. Current treatments include the use of psychotherapy and/or drugs, however similar to 30% of patients either do not respond to these treatments, or do not tolerate the side effects associated to the use of pharmacological interventions. Thus, it is important to study non-pharmacological interventions targeting mechanisms not directly involved with the regulation of neurotransmitters. Several studies demonstrated that transcranial Direct Current Stimulation (tDCS) can be effective for symptoms relief in MDD. However, tDCS seems to have a better effect when used as an add-on treatment to other interventions.Methods/Design: This is a study protocol for a parallel, randomized, triple-blind, sham-controlled clinical trial in which a total of 90 drug-naive, first-episode MDD patients (45 per arm) will be randomized to one of two groups to receive a 6-weeks of CBT combined with either active or sham tDCS to the dorsolateral prefrontal cortex (DLPFC). The primary outcome will depressive symptoms improvement as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) at 6-weeks. The secondary aim is to test whether CBT combined with tDCS can engage the proposed mechanistic target of restoring the prefrontal imbalance and connectivity through the bilateral modulation of the DLPFC, as assessed by changes over resting-state and emotional task eliciting EEG.Discussion: This study evaluates the synergetic clinical effects of CBT and tDCS in the first episode, drug-naive, patients with MDD. First episode MDD patients provide an interesting opportunity, as their brains were not changed by the pharmacological treatments, by the time course, or by the recurrence of MDD episodes (and other comorbidities). |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-11-03 2020-11-03T00:00:00Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/1822/69945 |
url |
http://hdl.handle.net/1822/69945 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Carvalho, S., Gonçalves, Ó. F., Brunoni, A. R., Fernandes-Gonçalves, A., Fregni, F., & Leite, J. (2020). Transcranial Direct Current Stimulation as an Add-on Treatment to Cognitive-Behavior Therapy in First Episode Drug-Naïve Major Depression Patients: The ESAP Study Protocol. [10.3389/fpsyt.2020.563058]. Frontiers in Psychiatry, 11, 1149. DOI: 10.3389/fpsyt.2020.563058 1664-0640 10.3389/fpsyt.2020.563058 https://www.frontiersin.org/articles/10.3389/fpsyt.2020.563058 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Frontiers Media S.A. |
publisher.none.fl_str_mv |
Frontiers Media S.A. |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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