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Clinical trial Recruiting at 2 sites Interventional Ages 18 and up Women only

Tailored behavioral programs to improve sleep in first-time mothers

Official title: The Sleep-MOMagement Project: Effectiveness of Person-centred Behavioural Interventions for Postpartum Maternal Sleep Improvement in Sleep-disturbed First-time Mothers.

Run by Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek) · NCT07345065 · Data updated 2026-11-12

This study tests whether a person-centered behavioral sleep program or a guided aerobic exercise program helps first-time mothers 4–12 months after delivery with insomnia sleep better than usual postpartum care.

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment135 (estimated)
SponsorResearch Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
Academic / other
Locations2 sites (Brussels, Jette and 1 other locations)
StatusRecruiting
StartedJanuary 1, 2026
Main results expectedApril 1, 2028
Study endsNovember 1, 2028
Registry record updatedApril 6, 2026
Trial IDNCT07345065 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

First-time mothers 4–12 months postpartum after a singleton pregnancy who have an Insomnia Severity Index score >7, report insomnia at least three times per week for three months, have adequate Dutch literacy, and have access to a telephone and computer/email are ideal candidates.

Probably not a fit

Women who are currently pregnant, shift workers, have severe diagnosed psychiatric disorders, are non-Dutch speakers, or whose sleep problems are primarily caused by external factors (for example the baby or partner) may not benefit or are excluded from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional study will compare a behavioral sleep management program and a behavioral aerobic exercise program to usual postpartum care in 135 first-time mothers with (sub)clinical insomnia. Participants are randomized to one of the two interventions or to treatment-as-usual and will keep sleep and activity diaries and complete questionnaires at baseline, post-intervention, 3 months, and 6 months. The primary clinical outcome is change in insomnia severity at six months and the primary economic outcome is healthcare use, with secondary analyses exploring predictors, associations with mood and pain, and a qualitative process evaluation. Recruitment and intervention delivery are coordinated through physiotherapy departments at Vrije Universiteit Brussel and KU Leuven and use community and online outreach in the Brussels and Leuven areas.

Why it matters

Potential benefit: If successful, these programs could give first-time mothers practical, nonpharmacological tools to reduce insomnia symptoms and improve daily functioning.

How similar studies have gone: Behavioral insomnia treatments like CBT-I have shown clear benefit in general adult populations and some studies support exercise for improving sleep, but tailored postpartum behavioral programs remain less extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Women are eligible for study participation if they:

* (1) Have had a singleton pregnancy.
* (2) Are between 4 to 12 months postpartum with their first child.
* (3) Exhibit (sub)clinical insomnia, operationalized as an Insomnia Severity Index (ISI) score greater than 7 7 and having answered 'yes' on the following three statements: a) I have trouble falling asleep, and/or staying asleep and/or I have early morning awakenings AND this causes daytime symptoms. b) My sleeping problem is not caused by an external factor (the baby or my partner). c) These sleeping problems occur at least 3 times a week for at least 3 months.
* (4) Have access to a telephone, computer, and email.
* (5) Possess adequate Dutch literacy to comprehend therapy content, questionnaires, and instructions.

Exclusion Criteria:

Women are excluded from participation if they:

* (1) Are currently pregnant.
* (2) Are shift workers.
* (3) Have severe diagnosed psychopathologies (e.g., bipolar disorder, post-traumatic stress disorder, psychosis)
* (4) Have current severe or untreated sleep disorders (narcolepsy, restless legs syndrome, circadian rhythm disorders)
* (5) Have an unstable medical condition that may disrupt sleep.
* (6) Have received cognitive-behavioural therapy for insomnia (CBTi) within the last 6 months.
* (7) Experience sleep deprivation due to unsettled infant sleep/wake behaviour, defined as the infant waking more than three times per night for more than 30 minutes and requiring parental support to re-initiate sleep.

Where it's running

  • Vrije Universiteit Brussel, Health Campus, Department of Physiotherapy
    Brussels, Jette, Belgium     Recruiting
  • KU Leuven, Departement of Physiotherapy
    Leuven, Leuven, Belgium     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.