From Prevention to Treatment: How Biological Rhythms Can Maintain Perinatal Mental Health
NCT ID: NCT06246214
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-01-04
2027-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BlueLT
Participants with depressive and/or anxiety symptoms that will receive the interventional light (BlueLT)
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).
ControlLT
Participants with depressive and/or anxiety symptoms that will receive the placebo light (ControlLT)
ControlLT
The ControlLT (placebo) device is equipped with a dim long-wavelength enriched LED.
Healthy control
Participants without depressive and/or anxiety symptoms
No interventions assigned to this group
Interventions
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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).
ControlLT
The ControlLT (placebo) device is equipped with a dim long-wavelength enriched LED.
Eligibility Criteria
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Inclusion Criteria
* 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
* Psychotic symptoms;
* Unstable general medical conditions that interfere with the acquisition of actigraphy;
* Newborn with severe health conditions (hospitalization, care in the neonatal ICU).
18 Years
FEMALE
No
Sponsors
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Federal University of Rio Grande do Sul
OTHER
Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Principal Investigators
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Maria Paz L Hidalgo
Role: PRINCIPAL_INVESTIGATOR
+555133596339
Locations
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Tonon AC, Constantino DB, Amando GR, Abreu AC, Francisco AP, de Oliveira MAB, Pilz LK, Xavier NB, Rohrsetzer F, Souza L, Piccin J, Caye A, Petresco S, Manfro PH, Pereira R, Martini T, Kohrt BA, Fisher HL, Mondelli V, Kieling C, Hidalgo MPL. Sleep disturbances, circadian activity, and nocturnal light exposure characterize high risk for and current depression in adolescence. Sleep. 2022 Jul 11;45(7):zsac104. doi: 10.1093/sleep/zsac104.
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.
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.
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.
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.
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.
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.
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.
Pilz LK, Keller LK, Lenssen D, Roenneberg T. Time to rethink sleep quality: PSQI scores reflect sleep quality on workdays. Sleep. 2018 May 1;41(5). doi: 10.1093/sleep/zsy029.
Pilz LK, Carissimi A, Oliveira MAB, Francisco AP, Fabris RC, Medeiros MS, Scop M, Frey BN, Adan A, Hidalgo MP. Rhythmicity of Mood Symptoms in Individuals at Risk for Psychiatric Disorders. Sci Rep. 2018 Jul 30;8(1):11402. doi: 10.1038/s41598-018-29348-z.
Constantino DB, Xavier NB, Levandovski R, Roenneberg T, Hidalgo MP, Pilz LK. Relationship Between Circadian Strain, Light Exposure, and Body Mass Index in Rural and Urban Quilombola Communities. Front Physiol. 2022 Jan 26;12:773969. doi: 10.3389/fphys.2021.773969. eCollection 2021.
Pilz LK, Xavier NB, Levandovski R, Oliveira MAB, Tonon AC, Constantino DB, Machado V, Roenneberg T, Hidalgo MP. Circadian Strain, Light Exposure, and Depressive Symptoms in Rural Communities of Southern Brazil. Front Netw Physiol. 2022 Jan 26;1:779136. doi: 10.3389/fnetp.2021.779136. eCollection 2021.
Pilz LK, de Oliveira MAB, Steibel EG, Policarpo LM, Carissimi A, Carvalho FG, Constantino DB, Tonon AC, Xavier NB, da Rosa Righi R, Hidalgo MP. Development and testing of methods for detecting off-wrist in actimetry recordings. Sleep. 2022 Aug 11;45(8):zsac118. doi: 10.1093/sleep/zsac118.
Comiran Tonon A, Pilz LK, Amando GR, Constantino DB, Boff Borges R, Caye A, Rohrsetzer F, Souza L, Fisher HL, Kohrt BA, Mondelli V, Kieling C, Idiart M, Diez-Noguera A, Hidalgo MP. Handling missing data in rest-activity time series measured by actimetry. Chronobiol Int. 2022 Jul;39(7):964-975. doi: 10.1080/07420528.2022.2051714. Epub 2022 Mar 30.
Levandovski R, Dantas G, Fernandes LC, Caumo W, Torres I, Roenneberg T, Hidalgo MP, Allebrandt KV. Depression scores associate with chronotype and social jetlag in a rural population. Chronobiol Int. 2011 Nov;28(9):771-8. doi: 10.3109/07420528.2011.602445. Epub 2011 Sep 6.
Allebrandt KV, Teder-Laving M, Cusumano P, Frishman G, Levandovski R, Ruepp A, Hidalgo MPL, Costa R, Metspalu A, Roenneberg T, De Pitta C. Identifying pathways modulating sleep duration: from genomics to transcriptomics. Sci Rep. 2017 Jul 4;7(1):4555. doi: 10.1038/s41598-017-04027-7.
Alves Braga de Oliveira M, de Mendonca Filho EJ, Carissimi A, Lima Dos Santos Garay L, Scop M, Ruschel Bandeira D, Gutierrez Carvalho F, Mathur S, Epifano K, Adan A, Frey BN, Hidalgo MP. The Revised Mood Rhythm Instrument: A Large Multicultural Psychometric Study. J Clin Med. 2021 Jan 20;10(3):388. doi: 10.3390/jcm10030388.
Wittenbrink N, Ananthasubramaniam B, Munch M, Koller B, Maier B, Weschke C, Bes F, de Zeeuw J, Nowozin C, Wahnschaffe A, Wisniewski S, Zaleska M, Bartok O, Ashwal-Fluss R, Lammert H, Herzel H, Hummel M, Kadener S, Kunz D, Kramer A. High-accuracy determination of internal circadian time from a single blood sample. J Clin Invest. 2018 Aug 31;128(9):3826-3839. doi: 10.1172/JCI120874. Epub 2018 Aug 6.
Other Identifiers
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2022-0584
Identifier Type: -
Identifier Source: org_study_id
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