Postpartum Depression Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Hospital de Clínicas de Porto Alegre
RECRUITING
Porto Alegre
Contact Information
Primary
Maria Paz L Hidalgo
mhidalgo@hcpa.edu.br
+555133596339
Backup
Guilherme R Amando
gamando@hcpa.edu.br
+555133596339
Time Frame
Start Date: 2024-01-04
Estimated Completion Date: 2027-05
Participants
Target number of participants: 150
Treatments
Active_comparator: BlueLT
Participants with depressive and/or anxiety symptoms that will receive the interventional light (BlueLT)
Sham_comparator: ControlLT
Participants with depressive and/or anxiety symptoms that will receive the placebo light (ControlLT)
No_intervention: Healthy control
Participants without depressive and/or anxiety symptoms
Related Therapeutic Areas
Sponsors
Collaborators: Federal University of Rio Grande do Sul
Leads: Hospital de Clinicas de Porto Alegre

This content was sourced from clinicaltrials.gov