RecruitingNot ApplicableNCT05710991

Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties 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


Sponsor

St. Joseph's Healthcare Hamilton

Enrollment

102 participants

Start Date

Aug 10, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to improving sleep during early pregnancy: a brief course of cognitive behavioral therapy for insomnia (CBT-I, a structured talk-based therapy) versus basic sleep hygiene education, to see which works better for pregnant women struggling with sleep. **You may be eligible if...** - You are 18 or older - You are pregnant (up to 34 weeks along) - You are experiencing significant sleep difficulties (score of 8 or higher on an insomnia scale) - You are fluent in English **You may NOT be eligible if...** - You have severe depression or active suicidal thoughts, or psychosis - You have an unstable medical condition - You are currently using sleep aids (or taking a prescription sleep-related medication that has recently changed) - You have a sleep disorder other than insomnia, such as restless leg syndrome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSleep Hygiene Workshop

Psychoeducation on the perinatal period and sleep difficulties including principles of sleep hygiene conducive environment for sleep, bedtime routine, food, beverage, and stimulant consumption, exercise

BEHAVIORALCognitive Behavioural Therapy for Insomnia Workshop

The CBT-I workshop group contains empirically supported strategies for insomnia modified to target the transitions and concerns faced by perinatal individuals. Content includes Sleep drive, stimulus control, sleep restriction, counter-arousal techniques, cognitive restructuring


Locations(1)

St. Joseph's Healthcare Hamilton, West 5th Campus

Hamilton, Ontario, Canada

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NCT05710991


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