Tailored behavioral programs to improve sleep in first-time mothers
The Sleep-MOMagement Project: Effectiveness of Person-centred Behavioural Interventions for Postpartum Maternal Sleep Improvement in Sleep-disturbed First-time Mothers.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek) Academic / other |
| Locations | 2 sites (Brussels, Jette and 1 other locations) |
| Trial ID | NCT07345065 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Brussels, Jette and 1 other locations
- Vrije Universiteit Brussel, Health Campus, Department of Physiotherapy — Brussels, Jette, Belgium (Recruiting)
- KU Leuven, Departement of Physiotherapy — Leuven, Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Manon De deyne, Master
- Email: manon.de.deyne@vub.be
- Phone: +32498512698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.