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

St. Joseph's Healthcare Hamilton

Status: Enrolling

Conditions: Perinatal Depression; Sleep Disturbance; Perinatal Anxiety

Treatments: Behavioral: Cognitive Behavioural Therapy for Insomnia Workshop; Behavioral: Sleep Hygiene Workshop

Study type: Interventional

Funder types: Other

Identifiers

NCT05710991

CBTI-SleepHygiene-RCT

Details and patient eligibility

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.

Enrollment: 102 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥18 years
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

1. Severe depression/active suicidal ideation or psychotic
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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Sleep Hygiene Workshop

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sleep Hygiene Workshop

Cognitive Behavioural Therapy for Insomnia Workshop

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioural Therapy for Insomnia Workshop