[Triple Chronotherapy approach for reducing depressive symptoms and suicidal intent in hospitalized patients: Study protocol of a Randomized Controlled Trial].

Jun 30, 2020Professioni infermieristiche

Using Triple Chronotherapy to Reduce Depression and Suicidal Thoughts in Hospitalized Patients: Study Plan for a Controlled Trial

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Abstract

A randomized controlled trial is set to assess the efficacy of a triple chronotherapy intervention for improving depressive symptoms.

The study will evaluate the impact of total sleep deprivation, light therapy, and sleep phase advance on depression.
Participants will be individuals hospitalized with unipolar or bipolar depression and will be randomly assigned to either the intervention or control group.
The primary outcome is to verify if the triple chronotherapy results in rapid and stable improvement in depressive symptoms.
Enrolment for the trial started in December 2018 and is expected to conclude by October 2020 or when the target sample size is achieved.
Ethical approval for the study has been obtained, and it is registered under EudraCT 2019-000892-18.

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BACKGROUND: 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.

OBJECTIVES: 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.

METHODS: 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).

RESULTS: 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.

[Triple Chronotherapy approach for reducing depressive symptoms and suicidal intent in hospitalized patients: Study protocol of a Randomized Controlled Trial].

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