ACTIVE_NOT_RECRUITING

Perinatal Research on Improving Sleep and Mental Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-11-02
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05596318

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant 14-28 weeks gestation
  2. * 18 years or older
  3. * Daily access to a web-enabled computer, smart phone, or tablet
  4. * Current elevated insomnia symptom severity and insomnia disorder
  5. * English speaking
  1. * Current major depression
  2. * Taking or planning to take antidepressant medication (ADM)
  3. * Other diagnosed or suspected sleep disorder
  4. * Other psychiatric or medical issues (e.g., bipolar disorder, active suicidality, bed rest)
  5. * Night shift worker

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Francisco

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-02
Study Completion Date2027-04

Study Record Updates

Study Start Date2022-11-02
Study Completion Date2027-04

Terms related to this study

Additional Relevant MeSH Terms

  • Insomnia
  • Depression