Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Jennifer N Felder, PhD
Headshot of Jennifer N Felder
Jennifer N Felder

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 accepting new patients
    San Francisco California 94118 United States

Lead Scientist at UCSF

  • Jennifer N Felder, PhD
    Jennifer Felder, PhD, is a licensed clinical psychologist dedicated to promoting mental health during pregnancy and early parenting. In her research, Dr. Felder evaluates treatments to improve sleep and prevent depression. She is committed to increasing access to evidence-based interventions, particularly among populations disproportionately affected by poor health outcomes.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05596318
Study Type
Interventional
Participants
Expecting 498 study participants
Last Updated