NCT05710991 Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy
| NCT ID | NCT05710991 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Joseph's Healthcare Hamilton |
| Condition | Sleep Disturbance |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2023-08-10 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2023-08-10 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years 2. First, second, or third trimester of pregnancy (up to 34 weeks gestation) to allow for early/proactive benefit of sleep intervention. 3. Subjective difficulties with sleep (a score of 8 or higher on the Insomnia Severity Index) 4. Fluent in English. Exclusion Criteria: 1. Severe depression/active suicidal ideation or psychotic 2. Unstable general medical condition 3. Current use of sleep aids or if taking a prescriptive medication, it remains stable in dose and type for study duration 4. a sleep disorder other than insomnia (e.g., restless leg syndrome).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05710991 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Sleep Disturbance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05710991 currently recruiting?
Yes, NCT05710991 is actively recruiting participants. Contact the research team at sgreen@stjoes.ca for enrollment information.
Where is the NCT05710991 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT05710991 clinical trial?
NCT05710991 is sponsored by St. Joseph's Healthcare Hamilton. The trial plans to enroll 102 participants.