Actively Recruiting
Sleep-MOMagement: Improving Postpartum Sleep in First-time Mothers Through Tailored Behavioral Approaches.
Led by De deyne Manon · Updated on 2026-04-06
135
Participants Needed
2
Research Sites
147 weeks
Total Duration
On this page
Sponsors
D
De deyne Manon
Lead Sponsor
V
Vrije Universiteit Brussel
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to find out if person-centered behavioral interventions can help first-time mothers sleep better after childbirth. The study compares two approaches-a behavioral sleep management program and a behavioral aerobic exercise program-to usual postpartum care for women experiencing insomnia symptoms. The main clinical outcome is insomnia severity. The study also evaluates economic outcomes, including healthcare use, work absenteeism, overall health utility. Participants will: * Receive one of the interventions or continue with usual care. * Keep a sleep diary, a diary on physical activity, and complete questionnaires about sleep, mood, daily functioning, psychosocial factors, and economic outcomes. * Follow the program instructions, which may include sleep strategies or guided aerobic training, depending on the group.
CONDITIONS
Official Title
Sleep-MOMagement: Improving Postpartum Sleep in First-time Mothers Through Tailored Behavioral Approaches.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women who have had a singleton pregnancy.
- Between 4 to 12 months postpartum with their first child.
- Have subclinical or clinical insomnia defined by an Insomnia Severity Index score above 7 and specific sleep difficulties occurring at least 3 times a week for at least 3 months.
- Have access to a telephone, computer, and email.
- Have adequate Dutch literacy to understand therapy, questionnaires, and instructions.
You will not qualify if you...
- Currently pregnant.
- Shift workers.
- Diagnosed with severe psychiatric disorders such as bipolar disorder, post-traumatic stress disorder, or psychosis.
- Have severe or untreated sleep disorders like narcolepsy, restless legs syndrome, or circadian rhythm disorders.
- Have an unstable medical condition that may affect sleep.
- Received cognitive-behavioral therapy for insomnia within the last 6 months.
- Experience sleep deprivation caused by unsettled infant sleep waking more than three times per night for over 30 minutes requiring parental help.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Vrije Universiteit Brussel, Health Campus, Department of Physiotherapy
Brussels, Jette, Belgium, 1090
Actively Recruiting
2
KU Leuven, Departement of Physiotherapy
Leuven, Leuven, Belgium, 3000
Actively Recruiting
Research Team
M
Manon De deyne, Master
CONTACT
L
liesbet De Baets, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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