Personalized Integrated Chronotherapy for Perinatal Depression
Depression, Postpartum Depression, Prenatal Disorder
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- pregnant women, ages 18-45 years with a HAMD score >=14 and a current DSM-5 diagnosis of major depressive disorder as determined with the Current Major Depression Module of the Structured Clinical Interview for DSM disorders (SCID-I/P)
Exclusion Criteria:
- active psychosis or suicidality contraindicating outpatient treatment as determined by the clinical judgement of the research team and as measured with the B/C module of the SCID-I/P and the Columbia-Suicide Severity Rating Scale
- bipolar disorder (because sleep restriction can increase risk of conversion to mania)
- seizure disorder (because sleep restriction can increase seizure risk)
- self report of frequent migraines/headaches precipitated by bright light or sleep deprivation
- preexisting eye/skin disorders contraindicating light therapy
- use of photosensitizing medications
- primary Axis I diagnosis other than MDD (e.g., anorexia nervosa, ADHD)
- high risk pregnancy (e.g., conditions requiring mandatory bed rest or complex medical regimens that will interfere with study participation or conditions where poor infant outcomes are anticipated)
- starting antidepressants in the 4 weeks prior to enrollment
- current employment as night shift worker
- Alcohol Use Disorders Identification Test (AUDIT) score > 8 and/or Drug Abuse Screening Test (DAST) > 1 indicating current alcohol or drug use disorders
- women whose infants will not be living in the home or who will have a nighttime caregiver
- Pittsburgh Sleep Quality Inventory (PSQI)190 < 5 (i.e., those who report no sleep complaints during 3rd trimester of pregnancy and for whom an intervention targeting sleep might not be indicated).
- women who do not speak and read English because PIC research instruments are only available in English at this time. If this RCT shows effectiveness, future work will examine effectiveness in women who speak and read languages other than English.
- Women who experience fetal loss or stillbirth, as well as mothers whose infants are born before 36 weeks' gestation or have NICU stays > 5 days, will be discontinued from the study but will continue to receive UC.
Sites / Locations
- Feinstein Institute For Medical ResearchRecruiting
- University of North CarolinaRecruiting
- Rhode Island HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Usual Care
Personalize Integrated Chronotherapy
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).
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.