Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy
NCT ID: NCT05710991
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
102 participants
INTERVENTIONAL
2023-08-10
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Sleep Hygiene Workshop
The Sleep Hygiene workshop contains psychoeducation on sleep hygiene and has been modified to target the transitions and concerns faced by perinatal individuals. Sleep hygiene is commonly utilized as a treatment for insomnia in general practice, with the information provided through verbal advice and a sleep hygiene info sheet. As such, the sleep hygiene protocol used in this study reflects standard care commonly offered to perinatal individuals outside of our specialized clinic.
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
Cognitive Behavioural Therapy for Insomnia Workshop
The Cognitive Behavioural Therapy (CBT) for Insomnia workshop contains empirically supported strategies for insomnia that have been modified to target the transitions and concerns faced by perinatal individuals. CBT is the first-line treatment for insomnia and promising research on CBT for insomnia specifically during pregnancy and postpartum is emerging.
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
45 Years
FEMALE
No
Sponsors
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St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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Sheryl Green
Associate Professor, Clinical Psychologist
Locations
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St. Joseph's Healthcare Hamilton, West 5th Campus
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Sheryl Green, Ph.D., C.Psych
Role: backup
Other Identifiers
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CBTI-SleepHygiene-RCT
Identifier Type: -
Identifier Source: org_study_id
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