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

University of California, San Francisco1 site in 1 country456 target enrollmentNovember 2, 2022

ConditionsInsomnia Depression

InterventionsDigital CBT-I Digital SHE

Overview

Phase: Not Applicable
Intervention: Digital CBT-I
Conditions: Insomnia
Sponsor: University of California, San Francisco
Enrollment: 456
Locations: 1
Primary Endpoint: Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)
Status: Active, not recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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:

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.

Registry

clinicaltrials.gov

Start Date

November 2, 2022

End Date

April 30, 2027

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of California, San Francisco

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Digital cognitive behavior therapy for insomnia (CBT-I)

Intervention: Digital CBT-I

Digital sleep hygiene education (SHE)

Intervention: Digital SHE

Outcomes

Primary Outcomes

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

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)
Change in anxiety symptom severity, as assessed by the GAD-7(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)(Baseline to 12 months postpartum)
Change in suicidal ideation severity, as rated by the C-SSRS(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(Baseline to 10 weeks post-randomization (mediator))
Baseline depressive symptom severity as a moderator, as assessed by the EPDS(Baseline)
Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9(Baseline)