Perinatal Research on Improving Sleep and Mental Health

Running, not enrolling · Not applicable

Conditions studied: Insomnia, Depression

In brief

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.

Key facts

Study ID

NCT05596318

Run by

University of California, San Francisco

People needed

456

Starts

2022-11-02

Expected to finish

2027-04-30

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Current major depression
• 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)
• Night shift worker

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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