Digital Cognitive Behavioral Therapy for Insomnia Versus Sleep Hygiene Education for Prevention of Perinatal Depression: Protocol for a Randomized Clinical Trial.

Background: Insomnia during pregnancy is a modifiable risk factor for depression. Research in nonpregnant populations and preliminary findings in a pregnant population suggest that targeting insomnia with digital cognitive behavioral therapy for insomnia (CBT-I) may prevent depression. Objective: This study aims to evaluate the efficacy of digital CBT-I for the prevention of depression through 12 months post partum compared to that of a credible, clinically relevant comparator intervention, sleep hygiene education (SHE). This project will also provide valuable information about how and for whom CBT-I prevents perinatal depression. Methods: The Perinatal Research for Improving Sleep and Mental Health study is a fully remote, 2-arm parallel-group randomized controlled trial designed to test the superiority of digital CBT-I versus SHE for the prevention of perinatal depression. We aimed to randomize a target sample of at least 443 pregnant participants with insomnia disorder to digital CBT-I or SHE at a 1:1 ratio. Participants randomized to digital CBT-I received SleepioRx (Big Health, Inc), which uses sleep consolidation, stimulus control, cognitive therapy, relaxation techniques, and SHE in 6 interactive modules (5-15 min each). Participants randomized to SHE received information about sleep hygiene, the impact of sleep on performance, healthy sleep habits, lifestyle influences on sleep, and creating a sleep-friendly bedroom in 6 weekly digital handouts. Data are collected at baseline, 5 weeks after randomization, 10 weeks after randomization, 36 weeks' gestation, and 3, 6, 9, and 12 months post partum. The primary outcome is depression incidence, measured using the Structured Clinical Interview for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition]) Disorders, Research Version. Other outcome measures include the Edinburgh Postnatal Depression Scale, Patient Health Questionnaire-9, Columbia Suicide Severity Rating Scale, Generalized Anxiety Disorder Scale, and a birth outcomes questionnaire. Mediator measures include the Insomnia Severity Index, Consensus Sleep Diary, Structured Clinical Interview for Sleep Disorders, Perseverative Thinking Questionnaire, Dysfunctional Beliefs about Sleep Scale, Pre-sleep Arousal Scale, and Difficulties in Emotion Regulation-Short Form. Results: Data collection began in November 2022 and is projected to end in December 2026. Conclusions: If study hypotheses are supported, then this project will provide a new, scalable approach for preventing perinatal depression.