Personalized Integrated Chronotherapy for Perinatal Depression Samantha C.
1 Siler ,
BA, Kristina M.
1,2 Deligiannidis ,
MD, Katherine
3 Sharkey ,
MD, PhD
1Donald
and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY; 2Division of Psychiatry Research, Women’s Behavioral Health, Zucker Hillside Hospital, Northwell Health, New York, NY; 3Warren Alpert Medical School of Brown University, Providence, RI
Introduction •
Consequences of PPD may include increased morbidity and mortality, high economic burdens, maternal suicide, and unfavorable outcomes for the infants and children2,3.
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Many women who suffer from PPD decline treatment while pregnant and/or breastfeeding; roughly 50% of those who do seek treatment do not respond well to treatment currently available4.
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1 Week Before V2: • Start wearing actigraph continuously • Daily sleep diary • Daily morning call to report sleep/wake times • •
Evidence suggests that certain mood disorders may relate to circadian dysfunction, or issues stemming from the “internal body clock” that regulates the body’s cycle of sleep and wakefulness5.Integrated chronotherapy, which combines bright light therapy (BLT) and an established sleep schedule, has shown promising results as treatment for patients with unipolar6 and bipolar depression7,8 outside of the perinatal period9.
Start BLT at 30min/day Start personalized sleep schedule Saliva collection
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1 Week Before V4: • Daily sleep diary • Daily morning call to report sleep/wake times
One study suggests a difference between the circadian rhythms of non-depressed and depressed perinatal women, while another study recognizes significant phase shifts of circadian rhythm from the third trimester of pregnancy to 6 weeks postpartum10,11.
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1 Week Before V6: • Daily sleep diary • Daily morning call to report sleep/wake times
STUDY AIM: To investigate the efficacy of personalized, integrated chronotherapy (PIC; i.e. bright light therapy and a prescribed sleep schedule) as a novel, non-pharmacological approach to improving mood in patients with major depression during the third trimester of pregnancy.
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HYPOTHESIS: •
As compared to women receiving usual care (UC) for depression during pregnancy, women receiving both UC and PIC will demonstrate greater improvement in depression and anxiety at pregnancy week 36 and postpartum week 6 as assessed by changes from baseline HAMD (Hamilton Rating Scale for Depression) and HAMA (Hamilton Rating Scale for Anxiety) scores.
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Observed decreases in HAMD and HAMA scores will be justified by PIC-related changes in circadian rhythm.
Visit 1/Screening 24-28 Weeks Pregnancy
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Screening interview and forms Confirm eligibility
Visit 2/Baseline 28-30 Weeks Pregnancy
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Download actigraph sleep and light data Baseline mood assessment Assign sleep schedule
Visit 3 33 Weeks Pregnancy
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Visit 4 36 Weeks Pregnancy
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Download actigraph sleep and light data Repeat mood assessments
Visit 5 2 Weeks Postpartum
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Visit 6 6 Weeks Postpartum
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Download actigraph sleep and light data Repeat mood assessments Reassign sleep schedule
Visit 7 18 Weeks Postpartum
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Infant assessments Repeat mood assessments Debriefing
Saliva Collection
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Download actigraph sleep and light data Repeat mood assessments
Figure 1 Study Design •
Treatment and feasibility study aiming to enroll 220 women.
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Inclusionary: 18-40-year-old women, 24-28 weeks pregnant, baseline HAMD-17 score > 14 and current DSM-5 diagnosis of MDD as determined with SCID-I/P during screening visit (V1), sleep disturbances as verified by Pittsburgh Sleep Quality Inventory (PSQI) > 5.
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Exclusionary: Active psychosis or suicidality, bipolar disorder, seizure disorder, self-report of frequent migraines/headaches precipitated by bright light or sleep deprivation, preexisting skin/eye disorders contraindicating light therapy, use of photosensitizing medications, primary Axis I diagnosis other than MDD, high risk pregnancy, starting antidepressants within four weeks prior to enrollment, current employment as a nightshift worker, AUDIT score > 8 and/or DAST >1, women whose infants will not be living in the home or who will have a nighttime caregiver, women who do not speak and read English.
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Actigraphy data and sleep diary are used to prescribe a personalized sleep schedule.
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Subjects follow a prescribed sleep schedule and use a bright light box every morning within first 45-60 minutes of waking for 15-60 minutes. Mood and sleep assessments are used to assess changes in baseline symptoms and adjust prescribed sleep schedule.
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Saliva samples are collected per an assigned time frame for each of the weeks following visits 2, 4, and 6 to measure melatonin concentrations.
This is an actively enrolling study and therefore results are not yet available. The expected date of completion is 2023.
Conclusions •
Previous studies demonstrate that both BLT and sleep scheduling are effective at reducing depressive symptoms in the peripartum period as evaluated by reduced HAMD scores following treatment.
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The results of the current study are critical in assessment of symptom relief with the use of nonpharmaceutical treatments in women with postpartum depression.
Future Direction
Download actigraph sleep and light data Repeat mood assessments Reassign sleep schedule
Saliva Collection
Aims and Hypothesis •
Results •
Peripartum depression (PPD), major depression occurring in women who are either pregnant or postpartum, occurs in approximately 8-15% of perinatal women1.
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Methods
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The analysis of the data collected during this study will serve as an important step in developing chronotherapy as an alternative or adjunctive treatment for perinatal depression.
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Additional examination of the effects of the amount of melatonin in maternal breastmilk on infant sleep patterns may aid exploration of the impact of maternal circadian rhythm on infant health.
Funding and References Funding: 1. This study is funded by the National Institutes of Health (1R01MH118269) awarded to Drs. Sharkey (PI) and Deligiannidis (sub-award PI). The authors have no conflict of interests directly related to this study. References: 1. Dietz PM, Williams SB, Callaghan WM, Bachman DJ, Whitlock EP, Hornbrook MC. Clinically identified maternal depression before, during, and after pregnancies ending in live births. Am J Psychiatry. 2007;164(10):1515-1520. 2. Bonari L, Pinto N, Ahn E, Einarson A, Steiner M, Koren G. Perinatal risks of untreated depression during pregnancy. Can J Psychiatry. 2004;49(11):726-735. 3. Petrou S, Cooper P, Murray L, Davidson LL. Economic costs of post-natal depression in a high-risk British cohort. Br J Psychiatry. 2002;181:505-512. 4. Sockol LE, Epperson CN, Barber JP. A meta-analysis of treatments for perinatal depression. Clin Psychol Rev. 2011;31(5):839-849. 5. Kronfeld-Schor N, Einat H. Circadian rhythms and depression: human psychopathology and animal models. Neuropharmacology. 2012;62(1):101-114. 6. Moscovici L, Kotler M. A multistage chronobiologic intervention for the treatment of depression: a pilot study. J Affect Disord. 2009;116(3):201-207 7. Gottlieb JF, Terman M. Outpatient triple chronotherapy for bipolar depression: case report. J Psychiatr Pract. 2012;18(5):373-380. 8. Sit DK, McGowan J, Wiltrout C, et al. Adjunctive Bright Light Therapy for Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2017:appiajp201716101200. 9. Wirz-Justice A, Benedetti F, Terman M. Chronotheraputics for Affective Disorders: A Clinician's Manual for Light and Wake Therapy. Basel, Switzerland: Karger; 2009. 10. Parry BL, Meliska CJ, Sorenson DL, et al. Plasma melatonin circadian rhythm disturbances during pregnancy and postpartum in depressed women and women with personal or family histories of depression. Am J Psychiatry. 2008;165(12):1551-1558. 11. Sharkey KM, Pearlstein TB, Carskadon MA. Circadian phase shifts and mood across the perinatal period in women with a history of major depressive disorder: A preliminary communication. J Affect Disord. 2013;150(3):1103-1108.