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Life sciences · Interventional Study
ClinicalTrials.gov · October 2, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05356364). This is a study registration, not published results. Lead sponsor: Henry Ford Health System. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 100 participants (ACTUAL). Conditions: Insomnia, Depression. Interventions: BEHAVIORAL: Cognitive Behavioral Therapy for Insomnia (CBTI); BEHAVIORAL: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS). Primary outcome measures: Comparative effectiveness between PUMAS and CBTI on acute insomnia effects. , The investigators will examine change in ISI scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.; Comparative effectiveness between PUMAS and CBTI on postpartum insomnia effects. , The investigators will examine changes in ISI scores across the first postnatal year, which will be assessed at 3, 6, 9, and 12 months postpartum... Brief summary: Nearly half of women develop insomnia during pregnancy, which is associated with increased risk for developing perinatal depression. The purpose of this research is to evaluate the implementability and effectiveness of a mindfulness-based therapy for insomnia relative to cognitive-behavioral therapy for insomnia in pregnant women with insomnia and comorbid depression. The investigators aim to examine whether a mindfulness-based intervention effectiveness reduces symptoms of insomnia and comorbid depression.