Perinatal Research on Improving Sleep and Mental Health

Not Applicable

Recruiting

• Conditions: Insomnia; Depression
• Interventions: Device: Digital SHE; Device: Digital CBT-I

• Registration Number: NCT05596318
• Lead Sponsor: University of California, San Francisco

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-27
• Study Start: 2022-11-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 498

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital sleep hygiene education (SHE)	Digital SHE	-
Digital cognitive behavior therapy for insomnia (CBT-I)	Digital CBT-I	-

Primary Outcome Measures

Name	Time	Method
Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)	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 Outcome Measures

Name	Time	Method
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	The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity.
Change in anxiety symptom severity, as assessed by the GAD-7	Baseline to 12 months postpartum	The Generalized Anxiety Disorder-7 score ranges from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Change in suicidal ideation severity, as rated by the C-SSRS	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 depressive symptom severity as a moderator, as assessed by the EPDS	Baseline	The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity.
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	The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.
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)	The Insomnia Severity Index (ISI) score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9	Baseline	The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States