Recruiting

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

ClinicalTrials.gov IDNCT05710991

PhaseNA

Enrollment102

SponsorSt. Joseph's Healthcare Hamilton

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Sleep Disturbance, Perinatal Anxiety, Perinatal Depression

About this study

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 outcomes

Insomnia Severity Index (ISI) (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 information

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).

Study locations

St. Joseph's Healthcare Hamilton, West 5th Campus, Hamilton, Ontario L9C 0E3 Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.