From Prevention to Treatment: How Biological Rhythms Can Maintain Perinatal Mental Health
NCT06246214 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-12-03
Summary
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
- Depression, Postpartum
- Anxiety State
Interventions
- DEVICE
-
Blue Light Therapy
The BlueLT device is equipped with a narrow band short wavelength Light Emitting Diode (LED) - wavelength peak(λp) of \~470 nm (blue).
- DEVICE
-
ControlLT
The ControlLT (placebo) device is equipped with a dim long-wavelength enriched LED.
Sponsors & Collaborators
-
Federal University of Rio Grande do Sul
collaborator OTHER -
Hospital de Clinicas de Porto Alegre
lead OTHER
Principal Investigators
-
Maria Paz L Hidalgo · +555133596339
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-04
- Primary Completion
- 2027-05-31
- Completion
- 2027-05-31
Countries
- Brazil
Study Locations
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