From Prevention to Treatment: How Biological Rhythms Can Maintain Perinatal Mental Health
Recruiting · NCT06246214 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital de Clinicas de Porto Alegre
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 4-6 weeks postpartum;
- Postnatal depression confirmed through Edinburgh Postnatal Depression Scale (EPDS) \> 10;
- Mini-International Neuropsychiatric Interview (M.I.N.I.) positive for current depressive episode.
Exclusion criteria
- Active suicidal ideation;
- Psychotic symptoms;
- Unstable general medical conditions that interfere with the acquisition of actigraphy;
- Newborn with severe health conditions (hospitalization, care in the neonatal ICU).
Where it is running
1 location listed.
- Hospital de Clínicas de Porto Alegre - Porto Alegre, Rio Grande do Sul, Brazil