Status:
COMPLETED
Personalized Integrated Chronotherapy for Perinatal Depression
Lead Sponsor:
Rhode Island Hospital
Collaborating Sponsors:
Northwell Health
University of North Carolina, Chapel Hill
Conditions:
Depression
Postpartum Depression
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
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 outc...
Detailed Description
The purpose of this research study is to collect data on whether adding light therapy and a prescribed sleep schedule to usual treatment for depression can reduce depression and anxiety symptoms durin...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04364646
Start Date
November 2 2020
End Date
June 30 2025
Last Update
December 9 2025
Active Locations (3)
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1
Feinstein Institute For Medical Research
Glen Oaks, New York, United States, 11004
2
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
3
Rhode Island Hospital
Providence, Rhode Island, United States, 02903