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Perinatal Research on Improving Sleep and Mental Health

NCT05596318 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2026-03-11

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Digital CBT-I

The digital CBT-I program is called Sleepio (Big Health, Ltd). Digital CBT-I will be delivered by an animated therapist in six weekly sessions that are approximately 10-20 minutes each. Sessions can be accessed via website or app at a time that is convenient for the participant. Session content is based on standard, in-person CBT-I protocols, and includes sleep restriction, stimulus control, cognitive therapy, relaxation techniques, and sleep hygiene education. The program is interactive, automated, and tailored to participant progress. Additionally, participants will receive supplemental CBT-I content tailored for prenatal and postpartum insomnia.

DEVICE

Digital SHE

The digital SHE program was created by Big Health, Ltd and has a total of six sessions. The content for SHE includes education about sleep stages, sleep architecture, sleep cycles; education about importance of sleep for performance, mood, and health; recommendations for developing healthy sleep habits; recommendations for lifestyle factors that impact sleep; recommendations for creating a sleep-friendly bedroom.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-02
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05596318 on ClinicalTrials.gov