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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

2020Journal article Open access
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dc.contributor.authorCarvalho, S
dc.contributor.authorGonçalves, ÓF
dc.contributor.authorBrunoni, AR
dc.contributor.authorFernandes-Gonçalves, A
dc.contributor.authorFregni, F
dc.contributor.authorLeite, J
dc.date.accessioned2021-01-03T17:24:45Z
dc.date.available2021-01-03T17:24:45Z
dc.date.issued2020
dc.description.abstractBackground: Major Depressive Disorder (MDD) affects more than 264 million people worldwide. Current treatments include the use of psychotherapy and/or drugs, however ~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-naïve, 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-naïve, 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). Trial Registration: This study is registered with the United States National Library of Medicine Clinical Trials Registry (NCT03548545). Registered June 7, 2018, clinicaltrials.gov/ct2/show/NCT03548545. Protocol Version 1.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationFront Psychiatry. 2020 Nov 3;11:563058.pt_PT
dc.identifier.doi10.3389/fpsyt.2020.563058pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.26/34515
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.subjectTerapia Cognitivo-Comportamentalpt_PT
dc.subjectPerturbação Depressivo Maiorpt_PT
dc.subjectEstimulação Transcraniana por Corrente Contínuapt_PT
dc.subjectCognitive Behavioral Therapypt_PT
dc.subjectDepressive Disorder, Majorpt_PT
dc.subjectTranscranial Direct Current Stimulationpt_PT
dc.titleTranscranial Direct Current Stimulation as an Add-on Treatment to Cognitive-Behavior Therapy in First Episode Drug-Naïve Major Depression Patients: The ESAP Study Protocolpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.awardURIinfo:eu-repo/grantAgreement/FCT/9471 - RIDTI/PTDC%2FPSI-ESP%2F29701%2F2017/PT
oaire.citation.startPage563058pt_PT
oaire.citation.titleFrontiers in psychiatrypt_PT
oaire.citation.volume11pt_PT
oaire.fundingStream9471 - RIDTI
project.funder.identifierhttp://doi.org/10.13039/501100001871
project.funder.nameFundação para a Ciência e a Tecnologia
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isProjectOfPublication0f51e7d0-736a-4853-b65a-88f05ea229e2
relation.isProjectOfPublication.latestForDiscovery0f51e7d0-736a-4853-b65a-88f05ea229e2

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