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Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy

StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated October 1, 2024 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Enrollment target: 40 to 102
    • Primary and study completion dates: Sep 2024 to Sep 2025
    • Start date changed from estimate of Feb 2023 to Aug 10, 2023
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 1 word
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05710991
Lead Sponsor St. Joseph's Healthcare Hamilton
Conditions
(from sponsor)		 Sleep Disturbance, Perinatal Anxiety, Perinatal Depression
Related terms Parasomnias
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov