Perinatal Research on Improving Sleep and Mental Health

Phase

N/A

Condition

Insomnia

Depression

Treatment

Digital CBT-I

Digital SHE

Clinical Study ID

NCT05596318

21-35440

Ages > 18
Female

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.

Eligibility Criteria

Inclusion

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

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, bedrest)
Night shift worker

Study Design