Mindfulness Sleep Program for Depression in Pregnancy
Sleep to Reduce Incident Depression Effectively in Peripartum
Recruiting
Phase 2
Interventional Study
Insomnia
Depression
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 500 (estimated)
- Sponsor
- Henry Ford Health System · Other
Who this trial is looking for
This trial is looking for pregnant women experiencing insomnia to join a program aimed at improving sleep and reducing the risk of depression during and after pregnancy. Participants will complete assessments and a mindfulness-based sleep program over a period of time.
Are You a Good Fit for This Trial?
You may be able to join if
- I am pregnant and between 14 and 31 weeks along.
- I have been diagnosed with insomnia for at least one month.
- I have a score of 11 or higher on the Insomnia Severity Index.
- I have a score below 13 on the Edinburgh Postnatal Depression Scale.
- I do not have major depression right now.
- I can access the internet reliably.
- I am not currently in therapy for depression or insomnia.
- I am at least 18 years old.
You may not be able to join if
- I have a high-risk pregnancy.
- I have thoughts of actively harming myself.
- I work at night or on rotating shifts.
- I anticipate traveling across three or more time zones in the next two months.
- I have untreated restless legs syndrome.
- I often feel excessively sleepy during the day.
- I have uncontrolled sleep or mental disorders that are unsafe for sleep restriction.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 effectiv…
Trial Locations
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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 ac…
Contacts