Perinatal Research on Improving Sleep and Mental Health

NAActive, not recruitingINTERVENTIONAL
Enrollment

456

Participants

Timeline

Start Date

November 2, 2022

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2027

Conditions
InsomniaDepression
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.

Trial Locations (1)

94118

University of California, San Francisco, San Francisco

All Listed Sponsors
collaborator

Stanford University

OTHER

lead

University of California, San Francisco

OTHER