NCT05710991

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disturbance
• Perinatal Anxiety
• Perinatal Depression

Interventions

Type	Name	Description
BEHAVIORAL	Sleep 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
BEHAVIORAL	Cognitive 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

Timeline

• Start date: 2023-08-10
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-02-02
• Last updated: 2024-10-01

Locations

1 site across 1 country: Canada