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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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).
• Устройство ControlLT
  The ControlLT (placebo) device is equipped with a dim long-wavelength enriched LED.

Первичные конечные точки

• Depressive symptoms [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Anxiety symptoms [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Hospital de Clínicas de Porto Alegre — Porto Alegre

Публикации

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• Roenneberg T, Foster RG, Klerman EB. The circadian system, sleep, and the health/disease balance: a conceptual review. J Sleep Res. 2022 Aug;31(4):e13621. doi: 10.1111/jsr.13621. Epub 2022 Jun 7. PMID 35670313
• Hidalgo MP, Caumo W, Posser M, Coccaro SB, Camozzato AL, Chaves ML. Relationship between depressive mood and chronotype in healthy subjects. Psychiatry Clin Neurosci. 2009 Jun;63(3):283-90. doi: 10.1111/j.1440-1819.2009.01965.x. PMID 19566758
• Xavier NB, Abreu ACVO, Amando GR, Steibel EG, Pilz LK, Freitas JJ, da Silveira Cruz-Machado S, Markus RP, Frey BN, Hidalgo MP. Chronobiological parameters as predictors of early treatment response in major depression. J Affect Disord. 2023 Feb 15;323:679-688. doi: 10.1016/j.jad.2022.12.002. Epub 2022 Dec 5. PMID 36481230
• Kramer A, Lange T, Spies C, Finger AM, Berg D, Oster H. Foundations of circadian medicine. PLoS Biol. 2022 Mar 24;20(3):e3001567. doi: 10.1371/journal.pbio.3001567. eCollection 2022 Mar. PMID 35324893
• Krawczak EM, Minuzzi L, Simpson W, Hidalgo MP, Frey BN. Sleep, daily activity rhythms and postpartum mood: A longitudinal study across the perinatal period. Chronobiol Int. 2016;33(7):791-801. doi: 10.3109/07420528.2016.1167077. Epub 2016 Apr 20. PMID 27097327
• Slyepchenko A, Minuzzi L, Reilly JP, Frey BN. Longitudinal Changes in Sleep, Biological Rhythms, and Light Exposure From Late Pregnancy to Postpartum and Their Impact on Peripartum Mood and Anxiety. J Clin Psychiatry. 2022 Jan 18;83(2):21m13991. doi: 10.4088/JCP.21m13991. PMID 35044728
• Pilz LK, Carissimi A, Francisco AP, Oliveira MAB, Slyepchenko A, Epifano K, Garay LLS, Fabris RC, Scop M, Streiner DL, Hidalgo MP, Frey BN. Prospective Assessment of Daily Patterns of Mood-Related Symptoms. Front Psychiatry. 2018 Aug 21;9:370. doi: 10.3389/fpsyt.2018.00370. eCollection 2018. PMID 30186188

Идентификаторы

NCT: NCT06246214 · 2022-0584

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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