BridgeMD
New treatment option for Insomnia
Official title Sleep-MOMagement: Improving Postpartum Sleep in First-time Mothers Through Tailored Behavioral Approaches.
ClinicalTrials.gov ID: NCT07345065
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- (4) Have access to a telephone, computer, and email.
You likely can't join 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.
See the full eligibility 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...
- (4) Have access to a telephone, computer, and email.
- (5) Possess adequate Dutch literacy to comprehend therapy content, questionnaires, and instructions.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Jette, Belgium
- Leuven, Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Jette, Belgium; Leuven, Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.