# A scalable cognitive behavioural therapy intervention for perinatal insomnia: a protocol for a hybrid effectiveness-implementation type 1 randomised controlled trial

## TL;DR

This study tests a digital therapy for insomnia during pregnancy and after childbirth to see if it works and can be widely used.

## Contribution

The study introduces a scalable digital CBT-I intervention for perinatal insomnia with a focus on implementation in community care.

## Key findings

- The trial will assess the effectiveness of a digital CBT-I program in reducing insomnia symptoms during pregnancy and postpartum.
- Barriers and enablers to implementing the program in community care will be explored using established frameworks.
- An economic evaluation will determine the cost-effectiveness of the intervention.

## Abstract

Insomnia symptoms during the perinatal period are prevalent and may contribute to negative mental health and birthing outcomes. Cognitive Behavioural Therapy for Insomnia (CBT-I) is a non-pharmacological therapy efficacious in the treatment of insomnia. Previous studies have shown the effectiveness of digital CBT-I during the perinatal period. However, to date, our understanding of whether this treatment can be effectively implemented in community perinatal care is limited.

In this two-arm hybrid effectiveness-implementation type 1 randomised controlled trial (RCT), eligible pregnant individuals with self-reported insomnia symptoms (Insomnia Severity Index > 7) will be randomised to either the CBT-I intervention (Healthy Sleep Program) or active control (sleep hygiene education). The primary outcome is maternal insomnia symptom severity at (i) one pregnancy endpoint and (ii) averaged across three times post birth for the postpartum endpoint. An economic evaluation will assess cost-effectiveness. Barriers and enablers to sustained implementation will be explored using the Theoretical Domains Framework and the Practical Robust Implementation and Sustainability Model.

This study will offer an understanding of the effectiveness, cost-effectiveness, and sustained implementation potential of a digital sleep health program in perinatal care. These outcomes will provide empirical evidence to inform broader implementation of a scalable sleep program to improve insomnia symptoms in perinatal populations.

Australian New Zealand Clinical Trials Registry ACTRN12622000940774. Registered on 1 July 2022.

The online version contains supplementary material available at 10.1186/s13063-025-09308-5.