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A scalable cognitive behavioural therapy intervention for perinatal insomnia: a protocol for a hybrid
Meagan E Crowther1, Orly Atzmon1, Christie J Bennett2
1Turner Institute for Brain and Mental Health, School of Psychological Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.
Trials
|December 30, 2025
Summary
This study evaluates a digital Cognitive Behavioural Therapy for Insomnia (CBT-I) program for perinatal populations. It assesses effectiveness, cost-effectiveness, and implementation in community care to improve sleep health.
Area of Science:
- Perinatal mental health
- Sleep science
- Implementation science
Background:
- Insomnia is common in the perinatal period, impacting maternal mental health and birth outcomes.
- Cognitive Behavioural Therapy for Insomnia (CBT-I) is an effective non-pharmacological insomnia treatment.
- Digital CBT-I shows promise, but its community perinatal care implementation needs investigation.
Purpose of the Study:
- To evaluate the effectiveness and cost-effectiveness of a digital CBT-I program (Healthy Sleep Program) in perinatal care.
- To assess the feasibility and sustainability of implementing this digital sleep health program within community settings.
- To provide evidence for scaling up interventions to improve perinatal sleep health.
Main Methods:
- A two-arm hybrid effectiveness-implementation randomized controlled trial (RCT).
- Pregnant individuals with insomnia (Insomnia Severity Index > 7) randomized to digital CBT-I or sleep hygiene education.
- Primary outcomes: maternal insomnia severity at pregnancy and postpartum endpoints; secondary: cost-effectiveness, implementation barriers/enablers using TDF and P-RISM.
Main Results:
- Primary outcome data on maternal insomnia symptom severity at pregnancy and postpartum endpoints will be collected.
- Cost-effectiveness analysis will determine the economic value of the intervention.
- Qualitative data on implementation barriers and enablers will be gathered.
Conclusions:
- The study will provide crucial data on the effectiveness, cost-effectiveness, and implementation potential of a digital sleep program for perinatal populations.
- Findings will inform the broader adoption of scalable sleep interventions to address perinatal insomnia.
- This research aims to improve maternal mental health and birth outcomes through enhanced sleep.
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