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RecruitingPhase 2

Sleep to Reduce Incident Depression Effectively in Peripartum

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a mindfulness-based sleep program for pregnant women with insomnia, or trouble sleeping. It aims to improve sleep, calm a busy mind, and lower the risk of depression during pregnancy and after birth.

Perinatal depression (PND) is the most common complication in pregnancy and postpartum, which increases risk for adverse perinatal outcomes such as preterm birth, maternal suicidal thoughts, and impaired mother-infant bonding. Insomnia often precedes PND cases and may serve as an entry point for interventions preventing PND. The proposed project is a large-scale clinical trial to test the effectiveness of a mindfulness-based sleep program designed for pregnant women to improve sleep and alleviate cognitive arousal to reduce risk for PND across pregnancy and postpartum.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Pregnant with one baby and 14–31 weeks pregnant at screening.
  • Have diagnosed insomnia lasting at least 1 month.
  • Score 11 or higher on the Insomnia Severity Index, a survey about sleep problems.
  • Score below 13 on the Edinburgh Postnatal Depression Scale, a survey about depression.
  • Do not currently have major depression.
  • Have reliable internet access for treatment and study check-ins.
  • Are not currently in therapy for major depression or insomnia.
  • Are age 18 or older.

Who can't join

  • Have a high-risk pregnancy, such as pre-eclampsia (a serious blood pressure problem), a placenta covering the cervix with bleeding, or another serious risk to you or your baby. High blood pressure and diabetes alone are allowed.
  • Currently intend to take your own life.
  • Work night or rotating shifts, or expect to travel across 3 or more time zones within 2 months after the first screening.
  • Have untreated restless legs syndrome, which causes an urge to move your legs. Treated restless legs syndrome is allowed.
  • Have extreme daytime sleepiness, with a score above 15 on the Epworth Sleepiness Scale.
  • Have an uncontrolled sleep or mental health disorder that makes limiting time in bed unsafe or unsuitable. Examples listed include narcolepsy (sudden sleep attacks), bipolar disorder (major mood swings), and epilepsy (seizures).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Singleton pregnancy, gestational week 14-31 at screening. 2. DSM-5 Insomnia Disorder (≥1 month duration). 3. Insomnia Severity Index (ISI) score ≥ 11. 4. Edinburgh Postnatal Depression Scale score\<13 at screening. 5. No current DSM-5 Major Depression. 6. Reliable internet access for treatment and assessments. 7. Not currently engaged in therapy for major depression or insomnia disorder. 8. Age 18 years or older. Exclusion Criteria: 1. High risk pregnancy (pre-eclampsia, placenta previa w/ hemorrhage, other conditions deemed serious risk to mother or fetus; hypertension and diabetes are allowed). 2. Active suicidal intent. 3. Night or rotating shift work, anticipated travel across time 3 or more time zones in the 2 months after baseline screening. 4. Untreated RLS (treated RLS is OK). 5. Excessive daytime sleepiness; Epworth Sleepiness Scale\>15. 6. Uncontrolled sleep or mental disorder inappropriate or unsafe for sleep restriction (narcolepsy, bipolar, epilepsy, etc.).

Study sites (1)

MI