Clinical trial NCT05596318: Perinatal Research on Improving Sleep and Mental Health
Official title: Efficacy of Digital Cognitive Behavior Therapy for Insomnia for the Prevention of Perinatal Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Depression
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2022-10-27
Enrollment: 498
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)
timeFrame: Baseline to 12 months postpartum
Secondary outcomes:
measure: Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline to 12 months postpartum
measure: Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline to 12 months postpartum
measure: Change in suicidal ideation severity, as rated by the C-SSRS
timeFrame: Baseline to 12 months postpartum
measure: Change in anxiety symptom severity, as assessed by the GAD-7
timeFrame: Baseline to 12 months postpartum
measure: Change in prenatal insomnia symptom severity as a mediator of the effect of digital CBT-I on perinatal depression, as assessed by the ISI
timeFrame: Baseline to 10 weeks post-randomization (mediator)
measure: Baseline depressive symptom severity as a moderator, as assessed by the EPDS
timeFrame: Baseline
measure: Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9
timeFrame: Baseline
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jennifer N Felder, PhD
role: PRINCIPAL_INVESTIGATOR
References: