Perinatal Research on Improving Sleep and Mental Health (NCT05596318) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Perinatal Research on Improving Sleep and Mental Health
United States456 participantsStarted 2022-11-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)