Actively Recruiting
A Randomized Controlled Trial Comparing Brief Cognitive Behavioural Therapy to Sleep Hygiene for Sleep Difficulties in Early Pregnancy
Led by St. Joseph's Healthcare Hamilton · Updated on 2024-10-01
102
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Sleep difficulties are common among pregnant and postpartum individuals and can negatively affect both parent and infant. This research compares two non-medication treatments for sleep problems during pregnancy: cognitive behavioural therapy (CBT) for insomnia and sleep hygiene education. CBT is recommended as the first treatment for insomnia, and shortened CBT sessions have shown promise during pregnancy and postpartum. Sleep hygiene education is commonly used and has been found to improve sleep issues. This study aims to evaluate which workshop is more effective for early pregnancy sleep difficulties. Participants will be randomly assigned to one of two group workshops. The CBT for Insomnia workshop includes strategies such as sleep drive regulation, stimulus control, sleep restriction, counter-arousal techniques, and cognitive restructuring, all adapted for perinatal concerns. The Sleep Hygiene workshop focuses on educating participants about sleep hygiene principles, including sleep environment, bedtime routines, food and drink, stimulant use, and exercise, tailored for perinatal transitions. Both treatments are delivered as group workshops during early pregnancy. Participants will be assessed over approximately 10 months at three timepoints: before treatment (prior to 26 weeks gestation), after treatment (up to 34 weeks gestation), and at 12 weeks postpartum. Researchers will measure changes in insomnia severity using the Insomnia Severity Index, along with multiple secondary measures related to anxiety, depression, emotion regulation, worry, pre-sleep arousal, and sleep quality. Assessments include self-report questionnaires, sleep diaries, polysomnography, and actigraphy watches. This comprehensive monitoring helps evaluate the impact of each treatment on sleep and related mental health during and after pregnancy.
CONDITIONS
Brief Title
Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Currently pregnant in the first, second, or third trimester up to 34 weeks gestation
- Experiencing subjective sleep difficulties with a score of 8 or higher on the Insomnia Severity Index
- Fluent in English
You will not qualify if you...
- Severe depression, active suicidal thoughts, or psychotic symptoms
- Unstable general medical conditions
- Current use of sleep aids or prescription medications unless dose and type have remained stable for the study duration
- Diagnosed sleep disorders other than insomnia, such as restless leg syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants attend either a Sleep Hygiene Workshop or a Cognitive Behavioural Therapy for Insomnia Workshop. These behavioral interventions focus on improving sleep quality through psychoeducation and empirically supported strategies tailored for perinatal individuals.
1 workshop visit and up to 7 weekly follow-up visits
Duration - Up to 12 weeks postpartum
Participants are monitored to assess changes in sleep and mental health outcomes up to 12 weeks postpartum.
3 visits at pre-treatment baseline, post-treatment, and 12 weeks postpartum
Trial Site Locations
Total: 1 location
1
St. Joseph's Healthcare Hamilton, West 5th Campus
Hamilton, Ontario, Canada, L9C 0E3
Actively Recruiting
Research Team
S
Sheryl Green, C.Psych
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here