Integrated Chronotherapy for Perinatal Depression
Condition: Depression; Major Depressive Disorder; Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Perinatal depression is a common and serious mood disorder that increases morbidity and
      mortality in new mothers and results 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 suffer from circadian rhythm disruption are at risk
      for perinatal depression. This R34 Pilot Effectiveness Studies and Services Research Grant
      seeks to test whether an Integrated Chronotherapy (IC) intervention can be implemented in an
      outpatient psychiatry setting to improve treatment outcomes for patients with perinatal
      depression. IC 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, sleep-wake behavior, social rhythms, and arousal. We will
      assess the feasibility, safety, and acceptability of an IC intervention for perinatal
      depressin by testing the treatment in expectant mothers diagnosed with major depressive
      disorder during 3rd trimester of pregnancy. We will randomize patients to either: (a) usual
      care (UC, n = 20) or (b) IC+UC (n = 20). IC+UC will have pregnancy and postpartum components
      and will be administered via an individualized case formulation approach tailored to each
      patient. After a baseline assessment, IC 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 administered by a perinatal psychiatrist and/or psychotherapy. UC will
      be quantified in both groups to evaluate differences between the IC+UC and UC groups. Mood
      will be measured in both groups by blinded clinician interview and patient self-report. We
      will assess the safety profile of the IC intervention with evaluation of side effects/adverse
      events. Importantly, the study will also examine the putative mechanisms by which IC is
      hypothesized to work and the "dose" of IC received by patients in the IC+UC group. All
      participants will wear wrist actigraphy/light monitors continuously during weeks 28-40 of
      pregnancy and postpartum weeks 2-6 to assess light exposure and sleep duration and timing.
      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. This pilot will allow us to refine the IC intervention for future integration into
      various clinical settings and establish an infrastructue for a larger (R01-scale) trial,
      including measuring acceptability of IC among UC clinicians and implementing web-based data
      collection to facilitate data sharing in the planned R01. Perinatal IC could have major
      public health impact due to the high prevalence of perinatal depression and its negative
      effects on mothers and their children. This project represents a first step toward achieving
      this goal, as it will provide the pilot data necessary to prepare for a larger scale
      intervention study focused on providing non-pharmacologic therapies and improving outcomes
      for women with perinatal depression.
    


Intervention name(s): Triple Chronotherapy; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): triple chronotherapy (TC will consist of bright light therapy, sleep phase advance, and sleep deprivation/restriction; UC will consist of medication administered by a perinatal psychiatrist and/or psychotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; major depressive disorder; postpartum depression; antenatal depression; sleep; circadian; bright light