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Recruiting NCT05710991

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

No phase Interventional Sleep Disturbance Perinatal Anxiety Perinatal Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep Hygiene Workshop, Cognitive Behavioural Therapy for Insomnia Workshop.
Who it may be relevant to
Registry conditions: Sleep Disturbance, Perinatal Anxiety, Perinatal Depression. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Controlled Trial Examining the Impact of a Brief, Proactive, Cognitive Behavioural Therapy Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Insomnia Severity Index (ISI) [Time frame: Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.]
Secondary outcome measures (11)
  • State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA). [Time frame: Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.]
  • Edinburgh Postnatal Depression Scale (EPDS) [Time frame: Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.]
  • Difficulties in Emotion Regulation Scale (DERS) [Time frame: Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.]
  • Generalized Anxiety Disorder 7-Item Scale (GAD-7) [Time frame: Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.]
  • Penn State Worry Questionnaire (PSWQ) [Time frame: Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.]
  • Pre-Sleep Arousal Scale (PSAS) [Time frame: Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.]
  • PROMIS Anxiety Short-Form (PROMIS-A-SF) [Time frame: Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.]
  • PROMIS Depression Short-Form (PROMIS-D-SF) [Time frame: Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.]
  • Consensus Sleep Diary (CSD). [Time frame: Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.]
  • Polysomnography (PSG). [Time frame: Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.]
  • Actigraphy watches. [Time frame: Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.]

Eligibility criteria

Inclusion criteria

  • ≥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 criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Canada · 1 center
  • St. Joseph's Healthcare Hamilton, West 5th Campus — Hamilton

Identifiers

NCT: NCT05710991 · CBTI-SleepHygiene-RCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗