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

November 25, 2025 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Depression and anxiety during pregnancy and the postnatal period are major public health concerns, particularly in low and middle-income settings. Alterations in biological rhythms, sleep disturbances, and reduced exposure to daylight have been associated with increased risk for these conditions. The perinatal period represents a unique model of circadian misalignment vulnerability, driven by specific challenges to the temporal organization of physiological and behavioral rhythms. Prior evidence indicates that increased sleep onset latency and sleep deficits elevate the risk of postnatal depression, with sleep disturbances being among the most prominent risk factors and associated with up to a four-fold increase in depression risk.

Emerging findings suggest that changes in circadian health indicators, including sleep patterns, rest-activity rhythms, and light exposure, play a significant role in mood regulation during the peripartum period. Chronobiological interventions may therefore represent promising strategies for both prevention and treatment.

This Randomised Clinical Trial (RCT) aims to evaluate the effectiveness of Blue Light Therapy (BlueLT) for reducing depressive symptoms in women with postpartum depression and to assess whether alignment between rest-activity rhythms and internal body time mediates treatment effects. Chronobiological measures will include rest-activity rhythms, light exposure patterns, temperature rhythms, sleep duration and timing, social jetlag, and the BodyTime assay (single blood sample).

Participants with postpartum depression will be randomly assigned to either the BlueLT intervention or placebo light therapy (ControlLT). The BlueLT device delivers short-wavelength, narrow-band LED light (λp ~470 nm), while the ControlLT device emits dim, long-wavelength-enriched light. All participants in both groups will use the assigned light device for 30 minutes each day before 16:00 (4 p.m.) for 30 consecutive days.

The trial will enroll 50 women with postpartum depression (25 in the BlueLT group and 25 in the ControlLT group) and an additional 100 healthy postpartum controls from the same cohort. This healthy control group will serve as a comparator for circadian changes unrelated to depressive symptoms or treatment/placebo effects, acknowledging that pregnancy and postpartum adaptations may independently affect circadian phase relationships.

Exclusion criteria include: history of major depressive or anxiety disorder; current psychotic disorder; night-shift work; active suicidal ideation or psychotic symptoms; unstable medical conditions interfering with actigraphy; and newborns with severe health conditions.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90410-000
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
        • Principal Investigator:
          • Maria Paz L Hidalgo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BlueLT
Participants with depressive and/or anxiety symptoms that will receive the interventional light (BlueLT)
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).
Sham Comparator: ControlLT
Participants with depressive and/or anxiety symptoms that will receive the placebo light (ControlLT)
Device: ControlLT
The ControlLT (placebo) device is equipped with a dim long-wavelength enriched LED.
No Intervention: Healthy control
Participants without depressive and/or anxiety symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: From enrollment to the end of treatment at 4 weeks
The EDPS was developed to identify women who may have postpartum depression. This scale consists of 10 short statements. The participant checks off one of four possible answers that is closest to how she has felt during the past week. Responses are scored 0, 1, 2 and 3 based on the seriousness of the symptom. Items 3, 5 to 10 are reverse scored (i.e., 3, 2, 1, and 0). The total score is found by adding together the scores for each of the 10 items. A total score higher than 10 indicate the presence of depressive symptoms. A reduction in depressive symptoms clinically significant (outcome measure) will consist in a minimum difference of 4 points on the EPDS.
From enrollment to the end of treatment at 4 weeks
Anxiety symptoms
Time Frame: From enrollment to the end of treatment at 4 weeks
The General Anxiety Disorder 7-item scale (GAD-7) is one of the tools used to screen for anxiety or to measure its severity. Total score is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Ranging from 0 to 21, the following threshold were previously proposed: 0-4 (minimal anxiety); 5-9 (mild anxiety); 10-14 (moderate anxiety); 15-21 (severe anxiety). A reduction in anxiety symptoms clinically significant (outcome measure) will consist in a minimum difference of 4 points on the GAD-7.
From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Federal University of Rio Grande do Sul

Investigators

  • Principal Investigator: Maria Paz L Hidalgo, +555133596339

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0584

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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