Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07345065

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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.
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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