Perinatal Research on Improving Sleep and Mental Health (PRISM)

March 9, 2026 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

456

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital cognitive behavior therapy for insomnia (CBT-I)
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.
Other Names:
  • Sleepio
Active Comparator: Digital sleep hygiene education (SHE)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)
Time Frame: Baseline to 12 months postpartum
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: Baseline to 12 months postpartum
The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity.
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)
Time Frame: Baseline to 12 months postpartum
The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.
Baseline to 12 months postpartum
Change in suicidal ideation severity, as rated by the C-SSRS
Time Frame: Baseline to 12 months postpartum

The Columbia Suicide Severity Rating Scale suicidal ideation score ranges from 1-5, with greater scores indicating more severe ideation, based on the following categories:

  1. - Wish to be Dead
  2. - Non-specific Active Suicidal Thoughts
  3. - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
  4. - Active Suicidal Ideation with Some Intent to Act, without Specific Plan
  5. - Active Suicidal Ideation with Specific Plan and Intent
Baseline to 12 months postpartum
Change in anxiety symptom severity, as assessed by the GAD-7
Time Frame: Baseline to 12 months postpartum
The Generalized Anxiety Disorder-7 score ranges from 0 to 21, with higher scores indicating greater anxiety symptom severity.
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
Time Frame: Baseline to 10 weeks post-randomization (mediator)
The Insomnia Severity Index (ISI) score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Baseline to 10 weeks post-randomization (mediator)
Baseline depressive symptom severity as a moderator, as assessed by the EPDS
Time Frame: Baseline
The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity.
Baseline
Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9
Time Frame: Baseline
The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Stanford University

Investigators

  • Principal Investigator: Jennifer N Felder, PhD, 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 Major Dates

Study Start (Actual)

November 2, 2022

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-35440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share data via the National Database for Clinical Trials related to Mental Illness (NDCT), which is a secure platform for scientific collaboration and data-sharing

IPD Sharing Time Frame

Annually

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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