Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06246214

From Prevention to Treatment: How Biological Rhythms Can Maintain Perinatal Mental Health

Led by Hospital de Clinicas de Porto Alegre · Updated on 2025-12-03

150

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

Sponsors

H

Hospital de Clinicas de Porto Alegre

Lead Sponsor

F

Federal University of Rio Grande do Sul

Collaborating Sponsor

AI-Summary

What this Trial Is About

Depression and anxiety are significant public health issues during pregnancy and the postnatal period, particularly affecting those in developing countries. Disruptions in biological rhythms, sleep problems, and low exposure to daylight are associated with a higher risk of these mental health issues. The perinatal period poses unique challenges to the temporal program, with evidence indicating that sleep disturbances significantly increase the risk of postnatal depression. A Randomised Clinical Trial (RCT) is being conducted to assess the effectiveness of Blue Light Therapy (BlueLT) in treating depressive and anxiety symptoms during the postpartum. The RCT will also investigate the alignment of rest-activity and internal body time as mediating factors. This study will focus on various chronobiological factors, including rest-activity rhythms, light exposure levels, temperature rhythms, sleep duration and phase, social jetlag, and BodyTime (assessed through a single blood sample). The goal is to recruit 50 women with postpartum depression, with 25 in the BlueLT intervention group and 25 in the ControlLT placebo group, alongside 100 healthy controls. The BlueLT device uses a short-wavelength LED lamp mainly composed by a wavelength peak on blue spectrum, while the ControlLT device has a dim long-wavelength LED. A Healthy Control group will also be included to account for changes unrelated to depression diagnosis or placebo/treatment effects. Exclusion criteria involve a history of major depressive or anxiety disorder, current psychotic disorder, night shift work, active suicidal thoughts, unstable medical conditions interfering with data collection, and newborns with severe health conditions. The study aims to evaluate the impact of BlueLT on postpartum depression and understand the role of chronobiological factors in the health/disease process.

CONDITIONS

Official Title

From Prevention to Treatment: How Biological Rhythms Can Maintain Perinatal Mental Health

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women 4 to 6 weeks postpartum
  • Postnatal depression confirmed with Edinburgh Postnatal Depression Scale score greater than 10
  • Positive diagnosis for current depressive episode by Mini-International Neuropsychiatric Interview
Not Eligible

You will not qualify if you...

  • Active suicidal thoughts
  • Psychotic symptoms
  • Unstable medical conditions interfering with actigraphy data collection
  • Newborns with severe health issues such as hospitalization or neonatal intensive care

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil, 90410-000

Actively Recruiting

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Research Team

M

Maria Paz L Hidalgo

CONTACT

G

Guilherme R Amando

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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