Active — Not RecruitingNot Applicable

Perinatal Research on Improving Sleep and Mental Health

United States456 participantsStarted 2022-11-02

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)

Timeframe: Baseline to 12 months postpartum

Trial details

NCT IDNCT05596318

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

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