Comparing cognitive behavioral therapy and sleep hygiene for sleep issues in early pregnancy
A Randomized Controlled Trial Examining the Impact of a Brief, Proactive, Cognitive Behavioural Therapy Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy
This study is testing whether a short therapy program or a sleep tips workshop can help pregnant people with sleep problems feel better during their pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | St. Joseph's Healthcare Hamilton Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT05710991 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a brief cognitive behavioral therapy (CBT) workshop compared to a sleep hygiene education workshop for pregnant individuals experiencing sleep disturbances. The focus is on those in their first, second, or third trimester, who report significant sleep difficulties. By utilizing non-medication-based approaches, the study seeks to provide effective solutions for improving sleep quality during pregnancy, which is crucial for both maternal and infant health.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18 and older, experiencing subjective sleep difficulties during their first to third trimester.
Not a fit: Patients with severe depression, active suicidal ideation, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide pregnant individuals with effective non-medication-based strategies to improve their sleep quality.
How similar studies have performed: Previous studies have shown that cognitive behavioral therapy is effective for treating insomnia during pregnancy, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Hamilton, Ontario
- St. Joseph's Healthcare Hamilton, West 5th Campus — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Sheryl Green, C.Psych
- Email: sgreen@stjoes.ca
- Phone: 905-522-1155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.