Clinical trial for Insomnia
Official title Sleep to Reduce Incident Depression Effectively in Peripartum
ClinicalTrials.gov ID: NCT06430333
What this study is testing
- What it's testing
- This study is testing whether a mindfulness-based sleep program helps prevent depression. It aims to improve sleep and calm the mind during pregnancy and after birth.
- Who it's for
- You may be able to join if you are pregnant and have trouble sleeping.
- What's involved
- You would take part in a mindfulness-based sleep program. This program is designed to help you sleep better and feel less tense.
- Time commitment
- The study lasts through your pregnancy and the time after you give birth.
- Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Singleton pregnancy, gestational week 14-31 at screening.
- DSM-5 Insomnia Disorder (≥1 month duration).
- Insomnia Severity Index (ISI) score ≥ 11.
- Edinburgh Postnatal Depression Scale score\<13 at screening.
- No current DSM-5 Major Depression.
You likely can't join if
- High risk pregnancy (pre-eclampsia, placenta previa w/ hemorrhage, other conditions deemed serious risk to mother or fetus
- Active suicidal intent.
- Night or rotating shift work, anticipated travel across time 3 or more time zones in the 2 months after baseline screening.
- Untreated RLS (treated RLS is OK).
- Excessive daytime sleepiness; Epworth Sleepiness Scale\>15.
- Uncontrolled sleep or mental disorder inappropriate or unsafe for sleep restriction (narcolepsy, bipolar, epilepsy, etc.).
See the full eligibility criteria
- Singleton pregnancy, gestational week 14-31 at screening.
- DSM-5 Insomnia Disorder (≥1 month duration).
- Insomnia Severity Index (ISI) score ≥ 11.
- Edinburgh Postnatal Depression Scale score\<13 at screening.
- No current DSM-5 Major Depression.
- Reliable internet access for treatment and assessments.
- Not currently engaged in therapy for major depression or insomnia disorder.
- Age 18 years or older.
- High risk pregnancy (pre-eclampsia, placenta previa w/ hemorrhage, other conditions deemed serious risk to mother or fetus; hypertension and diabetes are allowed).
- Active suicidal intent.
- Night or rotating shift work, anticipated travel across time 3 or more time zones in the 2 months after baseline screening.
- Untreated RLS (treated RLS is OK).
- Excessive daytime sleepiness; Epworth Sleepiness Scale\>15.
- Uncontrolled sleep or mental disorder inappropriate or unsafe for sleep restriction (narcolepsy, bipolar, epilepsy, etc.).
The study team makes the final eligibility decision.
Where it is enrolling
- Novi, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Novi, Michigan, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.