Digital cognitive behavior therapy for insomnia (CBT-I) for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Depression+2 More
Digital CBT-I - Device
Eligibility
18+
Female
What conditions do you have?
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Study 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.

Eligible Conditions
  • Depression
  • Insomnia

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Baseline to 12 months postpartum

Baseline
Depressive Symptoms
Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9
Week 10
Change in prenatal insomnia symptom severity as a mediator of the effect of digital CBT-I on perinatal depression, as assessed by the ISI
Month 12
Anxiety
Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
Depressive Symptoms
Change in suicidal ideation severity, as rated by the C-SSRS
Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)

Trial Safety

Trial Design

2 Treatment Groups

Digital sleep hygiene education (SHE)
1 of 2
Digital cognitive behavior therapy for insomnia (CBT-I)
1 of 2

Active Control

Experimental Treatment

498 Total Participants · 2 Treatment Groups

Primary Treatment: Digital cognitive behavior therapy for insomnia (CBT-I) · No Placebo Group · N/A

Digital cognitive behavior therapy for insomnia (CBT-I)
Device
Experimental Group · 1 Intervention: Digital CBT-I · Intervention Types: Device
Digital sleep hygiene education (SHE)
Device
ActiveComparator Group · 1 Intervention: Digital SHE · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 12 months postpartum

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,263 Previous Clinical Trials
11,466,543 Total Patients Enrolled
60 Trials studying Depression
18,843 Patients Enrolled for Depression
Stanford UniversityOTHER
2,148 Previous Clinical Trials
35,678,418 Total Patients Enrolled
96 Trials studying Depression
92,097 Patients Enrolled for Depression
Jennifer N Felder, PhDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
260 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be at least 18 years old.
You have access to a web-enabled computer, smart phone, or tablet.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: November 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.