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

Inclusion Criteria4

  • ≥18 years
  • First, second, or third trimester of pregnancy (up to 34 weeks gestation) to allow for early/proactive benefit of sleep intervention.
  • Subjective difficulties with sleep (a score of 8 or higher on the Insomnia Severity Index)
  • Fluent in English.

Exclusion Criteria4

  • Severe depression/active suicidal ideation or psychotic
  • Unstable general medical condition
  • Current use of sleep aids or if taking a prescriptive medication, it remains stable in dose and type for study duration
  • a sleep disorder other than insomnia (e.g., restless leg syndrome).

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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