Perinatal Research on Improving Sleep and Mental Health

Study Overview
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Brief Summary
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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.

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

Conditions
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Insomnia, Depression

Intervention / Treatment
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* Device: Digital CBT-I
* Device: Digital SHE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital cognitive behavior therapy for insomnia (CBT-I)<br> | Device: Digital CBT-I<br>* 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.<br>* Other names: Sleepio;|
| Active Comparator: Digital sleep hygiene education (SHE)<br> | Device: Digital SHE<br>* 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.<br>|

What is the study measuring?
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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) | 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) | 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) | 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 | 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 | 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. | 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. | 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. | 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. | Baseline |