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• W3038756451 abstract "Depressive disorders are a relevant burden for public health due to their prevalence and high levels of associated disability and mortality. Recent studies suggest that the combination of multiple chronotherapuetic interventions may reveal effective in the rapid improvement of depressive symptoms.This paper describes the protocol of a study that aims to test the efficacy of a triple chronotherapy intervention (combined total sleep deprivation, light therapy and sleep phase advance) in the improvement of depressive symptoms in individuals diagnosed with unipolar or bipolar depression.A randomized controlled trial will be conducted in patients hospitalized with a unipolar or bipolar depression at the Servizio Psichiatrico di Diagnosi e Cura inpatient unit of the San Paolo - ASST Santi Paolo e Carlo Hospital in Milan, Italy. Individuals will be randomly assigned to the intervention (triple chronotherapy add-on to standard pharmacological treatment) or to the control group (standard pharmacological treatment).Enrolment began in December 2018 and will end in October 2020, or at any earlier point in which the expected sample size will be reached. The study protocol has already been approved by the local ethics committee and is registered as EudraCT 2019-000892-18. Outcome analyses aim to verify whether triple chronotherapy produces a rapid and stable improvement in depressive symptoms in individuals hospitalized for an acute unipolar or bipolar depressive episode.I disturbi depressivi rappresentano un importante problema di salute pubblica in considerazione della prevalenza, degli elevati tassi di disabilità e di mortalità ad esso associati. Studi recenti suggeriscono che l'uso combinato di differenti interventi di cronoterapia possa rivelarsi efficace nel rapido miglioramento della sintomatologia depressiva.Questo articolo descrive il protocollo di uno studio che si pone l’obiettivo di stabilire l’efficacia di un intervento di tripla cronoterapia (trattamento combinato di privazione totale di sonno, luce terapia e allungamento di fase di sonno) nel miglioramento della sintomatologia depressiva di persone affette da depressione unipolare o bipolare.Verrà condotto un trial clinico randomizzato controllato con arruolamento di pazienti affetti da depressione unipolare o bipolare, ricoverati presso il Servizio Psichiatrico di Diagnosi e Cura dell’Ospedale San Paolo – ASST Santi Paolo e Carlo di Milano. I soggetti saranno assegnati in modo randomizzato all’intervento (Triple Chronotherapy in aggiunta al trattamento farmacologico standard) o al gruppo “controllo” (trattamento farmacologico standard).L’arruolamento, iniziato a dicembre 2018, con previsione di termine ad ottobre 2020, o prima in caso di raggiungimento del campione previsto. Il protocollo di studio ha già ricevuto l’approvazione da parte del comitato etico aziendale ed è stato registrato su EudraCT con N° 2019-000892-18. Le analisi che ne deriveranno mirano a verificare se la tripla cronoterapia produca un rapido e stabile miglioramento della sintomatologia depressiva in persone ricoverate per un episodio depressivo unipolare o bipolare." @default.
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• W3038756451 date "2020-07-01" @default.
• W3038756451 modified "2023-10-16" @default.
• W3038756451 title "[Triple Chronotherapy approach for reducing depressive symptoms and suicidal intent in hospitalized patients: Study protocol of a Randomized Controlled Trial]." @default.
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• W3038756451 doi "https://doi.org/10.7429/pi.2020.731026" @default.
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