Perinatal Research on Improving Sleep and Mental Health
Key facts
- Where
- San Francisco, United StatesSee the site
Where in United States
- University of California San FranciscoSan Francisco, United StatesNo longer taking part
Trial details
- Who runs it
- University of California, San Francisco
- Trial code
- NCT05596318
- Record updated
- 2 November 2026
- Original description
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:Read full original descriptionShow less
Efficacy of Digital Cognitive Behavior Therapy for Insomnia for the Prevention of Perinatal Depression
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.
Inclusion: Pregnant 14-28 weeks gestation; 18 years or older; Daily access to a web-enabled computer, smart phone, or tablet; Current elevated insomnia symptom severity and insomnia disorder; English speaking.
Exclusion: Taking or planning to take antidepressant medication (ADM); Other diagnosed or suspected sleep disorder; Other psychiatric or medical issues (e.g., bipolar disorder, active suicidality, bed rest); Current major depression; Night shift worker.