Perinatal Research on Improving Sleep and Mental Health

Last updated: December 4, 2024
Sponsor: University of California, San Francisco
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Insomnia

Treatment

Digital CBT-I

Digital SHE

Clinical Study ID

NCT05596318
21-35440
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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, bedrest)

  • Night shift worker

Study Design

Total Participants: 498
Treatment Group(s): 2
Primary Treatment: Digital CBT-I
Phase:
Study Start date:
November 02, 2022
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94118
    United States

    Active - Recruiting

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