Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy
Recruiting now · Not applicable
Conditions studied: Sleep Disturbance, Perinatal Anxiety, Perinatal Depression
In brief
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. Currently, there are two main non-medical treatments for sleep difficulties available. The first, cognitive behavioural therapy (CBT), is the first treatment recommended for insomnia and has been found to successfully treat insomnia during pregnancy and the postpartum period. In addition, shortened sessions of CBT for insomnia have also been found to successfully reduce sleep difficulties. The second option is sleep hygiene education which is the most commonly offered treatment for sleep difficulties and has been found to improve sleep problems. The present study will compare the effectiveness of a CBT for insomnia group workshop to a Sleep Hygiene group workshop.
Key facts
- Study ID
- NCT05710991
- Run by
- St. Joseph's Healthcare Hamilton
- People needed
- 102
- Starts
- 2023-08-10
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2024-10-01
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify 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 may not qualify 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).
Where it is running
- St. Joseph's Healthcare Hamilton, West 5th Campus — Hamilton, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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