Perinatal Research on Improving Sleep and Mental Health

Description

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.

Conditions

Insomnia, Depression

Study Overview

Study Details

Study overview

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.

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

Perinatal Research on Improving Sleep and Mental Health

Condition
Insomnia
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

Jennifer N Felder, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2027-04