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

NCT06246214 | Recruiting DMC

• 1 other identifier: 2022-0584
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression, Postpartum; Anxiety State

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

BlueLT

ACTIVE COMPARATOR

Participants with depressive and/or anxiety symptoms that will receive the interventional light (BlueLT)

Device: Blue Light Therapy

ControlLT

SHAM COMPARATOR

Participants with depressive and/or anxiety symptoms that will receive the placebo light (ControlLT)

Device: ControlLT

Healthy control

NO INTERVENTION

Participants without depressive and/or anxiety symptoms

Interventions

Blue Light Therapy DEVICE

The BlueLT device is equipped with a narrow band short wavelength Light Emitting Diode (LED) - wavelength peak(λp) of \~470 nm (blue).

BlueLT

ControlLT DEVICE

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

ControlLT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90410-000, Brazil

RECRUITING

Related Publications (18)

• 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.

  PMID: 35522984 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 29420828 BACKGROUND

• 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.

  PMID: 30061722 BACKGROUND

• 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.

  PMID: 35153809 BACKGROUND

• 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.

  PMID: 36925579 BACKGROUND

• 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.

  PMID: 35598321 BACKGROUND

• 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.

  PMID: 35350931 BACKGROUND

• 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.

  PMID: 21895489 BACKGROUND

• 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.

  PMID: 28676676 BACKGROUND

• 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.

  PMID: 33498431 BACKGROUND

• 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.

  PMID: 29953415 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Maria Paz L Hidalgo

  +555133596339

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Paz L Hidalgo

CONTACT

+555133596339; mhidalgo@hcpa.edu.br

Guilherme R Amando

CONTACT

+555133596339; gamando@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: January 4, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)