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Mindfulness sleep program aims to stop perinatal depression before it starts

NCT ID NCT06430333

Prevention Sponsor: Henry Ford Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a mindfulness-based sleep program for pregnant women with insomnia can prevent depression during and after pregnancy. Researchers will enroll 500 women and compare the program to standard care. The goal is to improve sleep and reduce the risk of perinatal depression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.).

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder insomnia Rumination Syndrome perinatal asphyxia prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression Insomnia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Henry Ford Medical Center

    RECRUITING

    Novi, Michigan, 48377, United States

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