This study is in progress, not accepting new patients

Perinatal Research on Improving Sleep and Mental Health

a study on Insomnia Sleep Disorders Depression

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Jennifer N Felder, PhD (ucsf)

Description

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.

Official Title

Efficacy of Digital Cognitive Behavior Therapy for Insomnia for the Prevention of Perinatal Depression

Keywords

Insomnia, Depression, Sleep Initiation and Maintenance Disorders, Digital CBT-I, Digital SHE, Digital cognitive behavior therapy for insomnia (CBT-I)

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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 CAN'T join 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

Location

  • University of California, San Francisco
    San Francisco 5391959 California 5332921 94118 United States

Lead Scientist at University of California Health

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05596318
Study Type
Interventional
Participants
About 456 people participating
Last Updated