Personalized Integrated Chronotherapy for Perinatal Depression
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Circadian Dysregulation
- Depression
- Postpartum Depression
- Pregnancy Related
- Prenatal Disorder
- Sleep Disturbance
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: outcome assessments are made by a blinded investigatorPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Only males
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 during pregnancy and the postpartum. The study is enrolling pregnant woman between the ages of 18 and 40 ...
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 during pregnancy and the postpartum. The study is enrolling pregnant woman between the ages of 18 and 40 who have been diagnosed with depression and (possibly) anxiety. This study takes place from the 3rd trimester of pregnancy to 18 weeks postpartum. Women who take part in this study will be randomly assigned ("randomized") into one of the study treatment groups (1) the "usual care" group (UC); or (2) the group that receives bright light therapy and a prescribed sleep schedule, also called the "Personalized Integrated Chronotherapy" group (PIC). The usual care group will receive medications and/or talk therapy as decided by the woman and her doctor. Women in the integrated chronotherapy group will receive usual care (as above) and will also receive a bright light box to sit with every morning for up to 60 minutes as prescribed by the study doctor. Light will be delivered with a portable, broad-spectrum light box. Both groups will have their sleep and light levels monitored during 3rd trimester of pregnancy (weeks 28-40) and weeks 2-6 and 18 after the baby is born (postpartum weeks 2-6 and 18) Sleep monitoring takes place in the home using a small wrist activity monitor called an "actigraph." Participants will also be asked to provide three saliva sample sets over the course of the study to measure melatonin levels. In addition to the "Personalized Integrated Chronotherapy" study treatment that will supplement the clinical care as described above, participants will be asked to come in for research study visits.
Tracking Information
- NCT #
- NCT04364646
- Collaborators
- Northwell Health
- Johns Hopkins University
- University of North Carolina, Chapel Hill
- Investigators
- Principal Investigator: Kristina M Deligiannidis, MD Northwell Health Principal Investigator: Jennifer Payne, MD Johns Hopkins University Principal Investigator: Samantha Meltzer-Brody, MD University of North Carolina, Chapel Hill
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