Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)

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Project Abstract. Insomnia disorder impacts one in two women by the end of their 3rd trimester, and half of pregnant women with insomnia endorse comorbid depression. Though cognitive-behavioral therapy for insomnia (CBTI) has efficacy in pregnancy, CBTI produces smaller effects on insomnia and depression as compared to non-perinatal patients. Our team has identified a promising candidate factor that predicts suboptimal response to insomnia therapy: high cognitive arousal, a transdiagnostic phenomenon of heightened cognitive activity, particularly in the form of perseverative thinking (worry, rumination). Nearly all pregnant women with insomnia have high cognitive arousal before insomnia therapy, but CBTI produces minimal effect on these symptoms. Pregnant women with high cognitive arousal after insomnia therapy are 4 times LESS likely to remit from insomnia, and 3 times MORE likely to have depression relative to women whose arousal decreases with therapy. In effort to enhance alleviation of cognitive arousal to optimize clinical outcomes, we placed efficacious behavioral sleep strategies within a mindfulness intervention framework to develop an insomnia therapy specifically for pregnant women: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS). Unlike CBTI, efficacy data show that PUMAS produces large reductions in insomnia, depression, and cognitive arousal relative to control. Moreover, efficacy data suggest that reducing cognitive arousal may represent a mechanism by which PUMAS reduces insomnia and depression. The next step in the NIMH phase of intervention development is to translate these efficacy data into real-world practice. Evaluating the acceptability, feasibility, and preliminary effectiveness of PUMAS implemented in real-world clinics is absolutely critical and has immense potential to reduce burden of maternal mental illness. Aligned with NIMH emphasis on experimental therapeutics approach, we will investigate reductions in cognitive arousal as a key mechanism by which PUMAS alleviates insomnia and depression. We propose an effectiveness-implementation hybrid type 1 pilot RCT wherein 100 pregnant women with DSM-5 insomnia disorder are randomized to telemedicine PUMAS or sham therapy control. We will implement PUMAS in all 23 women’s health clinics across Henry Ford Health System, centrally located in Metro Detroit. Implementation will reflect real-world clinic operations such that women receiving prenatal care who report sleep difficulties will be referred by OB physicians and midwifes to therapists embedded in the women’s health clinics for evaluation and treatment. After treatment, we will assess participants across the first postpartum year to preliminarily evaluate the durability of clinical outcomes. This project will not only test PUMAS preliminary effectiveness for insomnia and depression, but will also investigate whether PUMAS engages a key candidate mechanism (high cognitive arousal) that is operative for alleviating these clinical outcomes in the effectiveness context (PAR-21-131).