Sleep-MOMagement: Improving Postpartum Sleep in First-time Mothers Through Tailored Behavioral Approaches.

Recruiting now · Not applicable

Conditions studied: Insomnia

In brief

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.

Key facts

Study ID

NCT07345065

Run by

De deyne Manon

People needed

135

Starts

2026-01-01

Expected to finish

2028-11-01

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Vrije Universiteit Brussel, Health Campus, Department of Physiotherapy — Brussels, Jette, Belgium (enrolling)
• KU Leuven, Departement of Physiotherapy — Leuven, Leuven, Belgium (enrolling)

Full record on ClinicalTrials.gov

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