Personalized Integrated Chronotherapy for Perinatal Depression

Part of paid clinical trials in Glen Oaks, New York.

Sponsor
Rhode Island Hospital
Study ID
NCT04364646
Status
Completed

Conditions

  • Circadian Dysregulation
  • Depression
  • Postpartum Depression
  • Pregnancy Related
  • Prenatal Disorder
  • Sleep Disturbance

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Personalized Integrated Chronotherapy — BEHAVIORAL
    Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.

Study Details

Perinatal depression and anxiety are common, serious, and frequently overlapping disorders that increase morbidity and mortality in new mothers (including suicide) and result in poor infant/child outcomes. Current therapies often fail to produce recovery or are poorly tolerated, and many pregnant women seek non-pharmacologic therapy or forgo treatment when non-pharmacologic options are not available. Expectant and new mothers who experience circadian rhythm dysregulation are at increased risk for perinatal depression. This Confirmatory Efficacy Clinical Trial of Non-Pharmacological Interventions for Mental Disorders R01 seeks to test whether a Personalized Integrated Chronotherapy (PIC) intervention can improve treatment outcomes for pregnant patients seeking outpatient treatment for depression, with or without anxiety. PIC is a multicomponent treatment consisting of bright light therapy, sleep phase advance, and sleep stabilization/restriction that targets the Research Domain Criteria (RDoC) constructs of circadian rhythms and sleep-wake behavior. To increase sample size and diversity and accelerate recruitment, this study will be performed at 4 sites that differ in clinical structure and that have piloted the PIC intervention. The study will enroll expectant mothers diagnosed with major depressive disorder during 3rd trimester of pregnancy. Participants will be randomized to either: (a) usual care (UC, n = 110) or (b) PIC+UC (n = 110). PIC+UC will have pregnancy and postpartum components and will be administered via a personalized approach tailored to optimize the intervention based on each patient's individual circadian and sleep timing. After a baseline assessment, PIC will be prescribed during 5 dedicated clinical visits: three during 3rd trimester of pregnancy and 2 in the postpartum period. UC will consist of medication and/or psychotherapy. UC will be quantified in both groups to evaluate differences between the PIC+UC and UC groups. Mood will be measured in both groups by blinded clinician interview and patient self-report. The safety profile of the PIC intervention will be assessed by evaluation of side effects/adverse events. Importantly, the study will also examine the target mechanisms by which PIC is hypothesized to work and test the mediation effects of the circadian targets on improvement in mood symptoms. Participants will wear wrist actigraphy/light monitors continuously during weeks 28-40 of pregnancy and postpartum weeks 2-6 to assess light exposure and to estimate sleep timing and duration. Circadian phase (measured with salivary dim light melatonin onset) will be measured at baseline during pregnancy (\~30 weeks' gestation), at 36 weeks' gestation, and at postpartum week 6. Exploratory aims will examine associations between infant sleep behavior and maternal circadian rhythms and factors relevant to future dissemination of PIC. If this intervention is effective, perinatal PIC could change clinical practice and have major public health impact due to the high prevalence of perinatal depression and anxiety, the negative effects of mood disorders on mothers and their children, and the need to provide effective, novel, non-pharmacologic therapies for women with perinatal mood disorders.

Key Dates

Start date
Nov 2, 2020
Status verified
Nov 2025
Primary completion
Oct 22, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Usual Care
    Women in the usual care group receive medications and/or talk therapy. Sleep and light levels are monitored at home with wrist actigraphy during 3rd trimester of pregnancy (weeks 28-40) and weeks 2-6 and18 after the baby is born (postpartum weeks 2-6 and 18).
  • Experimental: Personalize Integrated Chronotherapy
    Women in the integrated chronotherapy group receive usual care (medications and/or talk therapy, as above) and also receive a bright light box to sit with every morning for up to 60 minutes as prescribed by the study doctor.

Primary Outcome Measure

Change in Depressive Symptoms [ Time Frame: change from baseline at 33 weeks of gestation ]

Locations (3)

FacilityCityStateZIPSite coordinators
Feinstein Institute For Medical ResearchGlen OaksNew York11004-
University of North CarolinaChapel HillNorth Carolina27599-
Rhode Island HospitalProvidenceRhode Island02903-

Find similar trials in Glen Oaks, NY

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Feinstein Institute For Medical Research· Glen Oaks, NYUniversity of North Carolina· Chapel Hill, NCRhode Island Hospital· Providence, RI

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