Perinatal Research on Improving Sleep and Mental Health

NCT05596318 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 21-35440
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement?
3. 3.Is the effect of digital CBT-I on perinatal depression moderated by baseline depressive symptom severity?

Conditions

Insomnia; Depression

Outcome Measures

Primary Outcomes (1)

• Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)

  This is a binary outcome that measures whether a participant experienced a depressive episode at any point since randomization.

  Baseline to 12 months postpartum

Secondary Outcomes (7)

• Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Edinburgh Postnatal Depression Scale (EPDS)

  Baseline to 12 months postpartum

• Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Patient Health Questionnaire-9 (PHQ-9)

  Baseline to 12 months postpartum

• Change in suicidal ideation severity, as rated by the C-SSRS

  Baseline to 12 months postpartum

• Change in anxiety symptom severity, as assessed by the GAD-7

  Baseline to 12 months postpartum

• Change in prenatal insomnia symptom severity as a mediator of the effect of digital CBT-I on perinatal depression, as assessed by the ISI

  Baseline to 10 weeks post-randomization (mediator)

Study Arms (2)

Digital cognitive behavior therapy for insomnia (CBT-I)

EXPERIMENTAL

Device: Digital CBT-I

Digital sleep hygiene education (SHE)

ACTIVE COMPARATOR

Device: Digital SHE

Interventions

Digital CBT-I DEVICE

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.

Also known as: Sleepio

Digital cognitive behavior therapy for insomnia (CBT-I)

Digital SHE DEVICE

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.

Digital sleep hygiene education (SHE)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant 14-28 weeks gestation
• 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 may not qualify 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Stanford University: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jennifer N Felder, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: November 2, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Annually

Locations

US (1)