InsomniaPRISMNCT05596318
Perinatal Research on Improving Sleep and Mental Health
A study testing Digital CBT-I and Digital SHE in people with Insomnia and Depression, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Insomnia, Depression
- What is being tested?
- Digital CBT-I and Digital SHE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2022to 23 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: 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:
- What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression?
- Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement?
- 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
- Insomnia, Depression
- Being tested
- Digital CBT-I, Digital SHE
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital CBT-IDevice
Also called Sleepio
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.
Digital SHEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital cognitive behavior therapy for insomnia (CBT-I) | Experimental | Not described Receives: Device: Digital CBT-I |
| Digital sleep hygiene education (SHE) | Active comparator | Not described Receives: Device: Digital SHE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity.
Measured: 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)
The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.
Measured: Baseline to 12 months postpartum
Change in suicidal ideation severity, as rated by the C-SSRS
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
Measured: Baseline to 12 months postpartum
Change in anxiety symptom severity, as assessed by the GAD-7
The Generalized Anxiety Disorder-7 score ranges from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Measured: 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
The Insomnia Severity Index (ISI) score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: Baseline to 10 weeks post-randomization (mediator)
Baseline depressive symptom severity as a moderator, as assessed by the EPDS
The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity.
Measured: Baseline
Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start2 Nov 2022
- Primary completion23 Oct 2026
- Study completion23 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Jennifer N Felder, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596318
- Sponsor's protocol ID
- 21-35440
- Acronym
- PRISM
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2022
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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
Publications
Felder JN, Moran PJ, McClelland B, Mah R, Sorensen C, Ponting C, Sobhani NC, Neuhaus J, Krystal A, Manber R. Digital Cognitive Behavioral Therapy for Insomnia Versus Sleep Hygiene Education for Prevention of Perinatal Depression: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2026 May 26;15:e90969. doi: 10.2196/90969.
PubMed 42190644
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Digital Cognitive Behavior Therapy for Insomnia for the Prevention of Perinatal Depression
- ClinicalTrials.gov ID
- NCT05596318
- Acronym / sponsor ID
- PRISM / 21-35440
- Conditions
- Insomnia, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 23 Oct 2026 (actual)
- Study completion
- 23 Oct 2026 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression?
- Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement?
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital cognitive behavior therapy for insomnia (CBT-I) | Experimental | Device: Digital CBT-I |
| Digital sleep hygiene education (SHE) | Active comparator | Device: Digital SHE |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital CBT-IAlso: SleepioThe 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 cognitive behavior therapy for insomnia (CBT-I) |
| Digital SHEThe 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. | Device | Digital sleep hygiene education (SHE) |
Primary outcome
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.
7 secondary outcomes
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
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
Change in suicidal ideation severity, as rated by the C-SSRS
Time frame: Baseline to 12 months postpartum
Change in anxiety symptom severity, as assessed by the GAD-7
Time frame: 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)
Baseline depressive symptom severity as a moderator, as assessed by the EPDS
Time frame: Baseline
Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Derived from this study: PubMed 42190644Felder JN, Moran PJ, McClelland B, Mah R, Sorensen C, Ponting C, Sobhani NC, Neuhaus J, Krystal A, Manber R. Digital Cognitive Behavioral Therapy for Insomnia Versus Sleep Hygiene Education for Prevention of Perinatal Depression: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2026 May 26;15:e90969. doi: 10.2196/90969.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer N Felder, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital CBT-I and Digital SHE in people with Insomnia and Depression, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID) (time frame: Baseline to 12 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05596318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.