Sleep to Reduce Incident Depression Effectively in Peripartum - (STRIDE P)

Project Abstract. Perinatal depression (PND) affects nearly 20% of pregnant and postpartum women, with estimates soaring above 30% during the COVID-19 pandemic. Prospective data show insomnia precedes over half of PND incidence and relapse cases more than doubling risk for major depression. This is highly significant to a large segment of the pregnant population as ~20% of women meet diagnostic criteria for insomnia disorder by the end of pregnancy. Fortunately, insomnia is a modifiable risk factor for PND, and insomnia may serve as an entry point to prevent PND incidence and relapse. Although cognitive-behavioral therapy for insomnia (CBTI) alleviates insomnia during pregnancy, it yields modest effects on PND and undertreats cognitive arousal (heightened cognitive activity, particularly in the forms of rumination and worry at night). Our team identified cognitive arousal as a promising candidate factor for alleviating insomnia and preventing depression via insomnia therapy. Indeed, undertreatment of cognitive arousal in pregnancy is associated with insomnia non-remission and continued depression after therapy. Moreover, patient stakeholders identify ‘calming a busy mind at night’ as a critical target for improving sleep and wellbeing during pregnancy. In effort to enhance alleviation of cognitive arousal to optimize clinical outcomes, we developed Perinatal Understanding of Mindful Awareness for Sleep (PUMAS). PUMAS places behavioral sleep strategies within a mindfulness intervention framework with all components tailored specifically for pregnancy. RCT data show that PUMAS yields large effects on insomnia, depression, and cognitive arousal relative to control, whereas CBTI alleviates insomnia but has mixed or minimal effects on PND and cognitive arousal. Our R34 pilot RCT shows PUMAS patients are more satisfied with their care than pregnant women treated with CBTI, and that clinic leadership and providers rate PUMAS as acceptable, feasible, and appropriate for implementation. PUMAS has immense potential to change the management of prenatal insomnia and to curb PND rates via preventive care. We propose a large-scale RCT of 500 women with DSM-5 insomnia disorder (without PND) who are randomized to PUMAS or sleep education control. We will evaluate the effectiveness of PUMAS for alleviating insomnia and preventing PND across pregnancy and the first postpartum year. This project will not only test PUMAS effectiveness for insomnia and PND prevention but will also investigate whether PUMAS engages a key candidate mechanism (high cognitive arousal) that is operative for addressing these clinical outcomes in the effectiveness context (PAR-21-130). We will recruit pregnant women from the 23 women’s health clinics and 5 maternal-fetal medicine clinics across HFH, centrally located in Metro Detroit. This application directly addresses research objectives under PAR-21-130, which states: “preventive and therapeutic interventions [should target] factors that have been empirically associated with risk for or the etiology, maintenance, severity/course of the disorder or condition of interest.”