"Personalized Integrated Chronotherapy for Perinatal Depression" (R01, NIMH)
Disrupted sleep is ubiquitous among expectant and new mothers and is associated with perinatal depression and anxiety. My team and I have previously shown that changes in light exposure patterns during pregnancy and the postpartum period are associated with circadian rhythm dysregulation and that these circadian alterations are related to perinatal depression. Although bright light therapy has been used to treat prenatal depression, this intervention has not been adapted widely and there are no studies testing circadian rhythm interventions to prevent postpartum depression.
My team and I developed an integrated sleep-circadian intervention called “personalized integrated chronotherapy” (PIC) to prevent postpartum depression that includes morning bright light and an earlier and stabilized sleep schedule. In our pilot R34 study, we showed that women with major depressive disorder during pregnancy who received PIC in addition to treatment as usual (TAU) had significantly fewer depression symptoms than women receiving TAU alone at 36 weeks of gestation and at 6 weeks and 6 months postpartum.
We were recently awarded an R01 to perform a multi-site confirmatory efficacy trial to test the PIC intervention for treating depression during pregnancy and preventing postpartum depression in a larger sample. We will also examine purported mechanisms of the PIC intervention and explore related biomarkers in the mother-infant dyad.
How Advance-CTR Helped
Advance-CTR supported our work both through access to specialized expertise and infrastructure as well as financial assistance through the Grant Resubmission Award. Through this funding, I was able to purchase the equipment that allowed us to pilot the PIC intervention at the other study sites. Demonstrating that we could run the protocol at all study sites was critical to obtaining R01 funding.
I also consulted with the Service Cores on the submission. The R01 proposal benefited enormously from the Biostatistics Core’s support to analyze our R34 pilot data and assist with the data management; the Biomedical Informatics Core provided key assistance in helping me develop the methods for the R01 proposal. Ultimately, my proposal received an 11-point bump upon resubmission and was selected for funding.
Now that we are finally getting the study up and running, we continue to work with Biostatistics Core members on the infrastructure needed to run a multi-site clinical trial successfully and to comply with reporting requirements and other benchmarking and data quality assessments.