RecruitingNot ApplicableNCT06246214

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

Innovations in Biological Rhythms in the Context of Mental Health: Effectiveness of New Technologies and Exposure to Different Lighting Patterns in Women During the Postpartum Period


Sponsor

Hospital de Clinicas de Porto Alegre

Enrollment

150 participants

Start Date

Jan 4, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment for postnatal depression — specifically whether adjusting sleep and activity patterns (circadian rhythm-based therapy) can improve mental health for new mothers. It focuses on women 4 to 6 weeks after giving birth who are experiencing depression. **You may be eligible if...** - You are 4 to 6 weeks postpartum (after giving birth) - You scored above 10 on the Edinburgh Postnatal Depression Scale, indicating postnatal depression - A structured interview (M.I.N.I.) confirmed you are currently experiencing a depressive episode **You may NOT be eligible if...** - You have active thoughts of suicide - You are experiencing psychotic symptoms (hallucinations, delusions) - You have a medical condition that makes wearing an activity tracker (actigraphy device) impossible - Your newborn has a serious health condition requiring intensive care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEBlue Light Therapy

The BlueLT device is equipped with a narrow band short wavelength Light Emitting Diode (LED) - wavelength peak(λp) of \~470 nm (blue).

DEVICEControlLT

The ControlLT (placebo) device is equipped with a dim long-wavelength enriched LED.


Locations(1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06246214


Related Trials