Using daily rhythms and blue light to support mental health after childbirth
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
This trial will test whether daily blue light therapy helps women 4–6 weeks after childbirth reduce postpartum depression and anxiety symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Trial ID | NCT06246214 on ClinicalTrials.gov |
What this trial studies
This randomized clinical trial compares blue light therapy to a control light intervention in women with postpartum depression 4–6 weeks after delivery. Participants will wear actigraphy devices and have a single blood sample taken to measure internal body time (BodyTime), while researchers track light exposure, temperature rhythms, sleep timing and duration, and social jetlag. The study will test whether blue light reduces depressive and anxiety symptoms and whether improvements are mediated by better alignment between rest-activity rhythms and internal circadian time. Eligible participants must have EPDS >10 and a current depressive episode on the M.I.N.I., with key exclusions for active suicidal ideation, psychosis, unstable medical conditions, or a newborn in intensive care.
Who should consider this trial
Good fit: Women 4–6 weeks postpartum with confirmed postnatal depression (EPDS >10 and M.I.N.I. diagnosis) who do not have active suicidal ideation, psychosis, unstable medical conditions, or a newborn in neonatal intensive care are the intended participants.
Not a fit: Women with active suicidal ideation, psychotic symptoms, unstable medical illnesses, or whose newborn requires intensive care are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, blue light therapy could offer a low-cost, non-drug option to reduce postpartum depressive and anxiety symptoms and improve sleep and circadian alignment.
How similar studies have performed: Light therapy and other chronobiological interventions have shown benefit for seasonal and non-seasonal depression, but blue light therapy specifically in postpartum populations remains under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Porto Alegre, Rio Grande do Sul
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
Study contacts
- Principal investigator: Maria Paz L Hidalgo — +555133596339
- Study coordinator: Maria Paz L Hidalgo
- Email: mhidalgo@hcpa.edu.br
- Phone: +555133596339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.