Compares treatment options for Sleep Disturbance
Official title Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy
ClinicalTrials.gov ID: NCT05710991
What this study is testing
- What it's testing
- Pregnant and postpartum individuals often have difficulty sleeping and these sleep problems can negatively impact both the parent and infant. Research suggests that pregnant individuals prefer non-medication-based treatment for their sleep difficulties but there is a lack of research on the success of sleep treatment during pregnancy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- ≥18 years
- First, second, or third trimester of pregnancy (up to 34 weeks gestation) to allow for early/proactive benefit of sleep intervention.
- Subjective difficulties with sleep (a score of 8 or higher on the Insomnia Severity Index)
- Fluent in English.
You likely can't join if
- Severe depression/active suicidal ideation or psychotic
- Unstable general medical condition
- Current use of sleep aids or if taking a prescriptive medication, it remains stable in dose and type for study duration
- a sleep disorder other than insomnia (e.g., restless leg syndrome).
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
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 to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada. 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.