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Life sciences · Interventional Study
ClinicalTrials.gov · November 2, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05596318). This is a study registration, not published results. Lead sponsor: University of California, San Francisco. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 456 participants (ACTUAL). Conditions: Insomnia, Depression. Interventions: DEVICE: Digital CBT-I; DEVICE: Digital SHE. Primary outcome measures: Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID) , Baseline to 12 months postpartum. Brief summary: The goal of this clinical trial is to compare two sleep programs in pregnant people with insomnia. The main questions it aims to answer are: 1. What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression? 2. Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement? 3. Is the effect of digital CBT-I on perinatal depression moderated by baseline depressive symptom severity? Participants will receive one of two sleep programs - SHE or CBT-I. Both involve six weekly online sessions. Participants will complete surveys and interviews until 1 year postpartum.