NCT05067569

App-delivered Sleep ThERapy for Older Individuals With Insomnia

App-delivered Sleep ThERapy for Older Individuals With Insomnia (ASTEROID Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Woolcock Institute of Medical Research · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This randomised, open, parallel controlled trial aims to compare the efficacy of a digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education on insomnia symptom severity in older adults aged 60 years and over. The trial will be totally online with participants recruited from the community across Australia.

Detailed description

Insomnia is a highly prevalent sleep disorder affecting up to 10% of the adult population and reports of over 40% in the older population. Current insomnia treatments focus heavily on symptom management with cognitive behavioural therapy for insomnia (CBTi), in both digital and face-to-face form as the recommended first-line treatment. Despite the strong evidence for digital CBTi, there are a lack of data related to older people and whether digital brief behavioural therapy is efficacious in this population. The investigators will conduct a fully online study comparing 6-weeks of digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education. Participants will be recruited, screened and determined eligibility and consent will be conducted online. Thereafter, participants will be randomly allocated to either dBBTi delivered via a mobile application called SleepFix or wait-listed control. The SleepFix app delivers sleep restriction therapy using a 4 stage approach to improve sleep efficiency. The control will consist of 3 online sleep health education modules provided bi-weekly with information about sleep and sleep hygiene without any specific insomnia therapy. Participants will be recruited using social media and directed to a website to determine eligibility and then provided access to either the dBBTi (SleepFix) or the control with a link to the first online module. At baseline, all participants will complete self-reported measures of insomnia, sleep, fatigue, sleepiness , anxiety, depression, quality of life, cognition and digital health literacy. These will be repeated at follow-up at weeks 8, 16 and 26.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	SleepFix mobile application	The SleepFix app is a novel, innovative way to deliver digital brief behavioural therapy for insomnia for adults.
BEHAVIORAL	Sleep Health Education	These internet-based modules provide an active control intervention consisting of 3 modules provided bi-weekly. The participant will receive a link to this information as each module is made available. Control participants will have full access to these modules for the duration of the study. They reflect basic educational information regarding sleep health for poor sleepers that is otherwise easily accessible on the internet.

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-01-31
• Completion: 2025-04-30
• First posted: 2021-10-05
• Last updated: 2025-12-22

Locations

1 site across 1 country: Australia