Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT05710991

Brief Cognitive Behavioural Therapy for Insomnia Versus 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

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Currently in the first, second, or third trimester of pregnancy, up to 34 weeks gestation
  • Having subjective sleep difficulties with an Insomnia Severity Index score of 8 or higher
  • Fluent in English
Not Eligible

You will not qualify if you...

  • Severe depression, active suicidal thoughts, or psychotic symptoms
  • Unstable general medical condition
  • Current use of sleep aids or prescriptive medication with dose or type changes during the study
  • Presence of a sleep disorder other than insomnia, such as restless leg syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Hamilton, Ontario, Canada, L9C 0E3

Actively Recruiting

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Research Team

S

Sheryl Green, C.Psych

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy | DecenTrialz