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Active, Not Recruiting

NCT Number: NCT05596318

Perinatal Research on Improving Sleep and Mental Health

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Insomnia Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Sleepio

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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:

    • - Wish to be Dead
    • - Non-specific Active Suicidal Thoughts
    • - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
    • - Active Suicidal Ideation with Some Intent to Act, without Specific Plan
    • - Active Suicidal Ideation with Specific Plan and Intent

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Stanford University

Registry information

Official study title

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

Acronym: PRISM

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 27, 2022
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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