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

Key facts

Where
Brussels and Leuven, BelgiumSee the 2 sites

Where in Belgium

  • Vrije Universiteit Brussel, Health Campus, Department of PhysiotherapyBrussels, BelgiumContact: Manon De deyne, MasterTaking people
  • KU Leuven, Departement of PhysiotherapyLeuven, BelgiumContact: Manon De deyne, MasterTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
De deyne Manon
Trial code
NCT07345065
Record updated
6 April 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: (6) Have received cognitive-behavioural therapy for insomnia (CBTi) within the last 6 months; (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; Women are excluded from participation if they:; (1) Are currently pregnant; (2) Are shift workers; (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.

ClinicalTrials.gov NCT07345065