Perinatal Research on Improving Sleep and Mental Health (PRISM)

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Insomnia; Depression

Treatments: Device: Digital CBT-I; Device: Digital SHE

Study type: Interventional

Funder types: Other

Identifiers

NCT05596318

21-35440

Details and patient eligibility

About

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.

Enrollment: 456 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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456 participants in 2 patient groups

Digital cognitive behavior therapy for insomnia (CBT-I)

Experimental group

Treatment:

Device: Digital CBT-I

Digital sleep hygiene education (SHE)

Active Comparator group

Treatment:

Device: Digital SHE