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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06246214
Other study ID # 2022-0584
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date January 4, 2024
Est. completion date May 2027

Study information

Verified date January 2024
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Blue Light Therapy
The BlueLT device is equipped with a narrow band short wavelength Light Emitting Diode (LED) - wavelength peak(?p) of ~470 nm (blue).
ControlLT
The ControlLT (placebo) device is equipped with a dim long-wavelength enriched LED.

Locations

Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (2)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

References & Publications (18)

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Outcome

Type Measure Description Time frame Safety issue
Primary Depressive symptoms 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
Primary Anxiety symptoms 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
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