Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000709448p
Ethics application status
Submitted, not yet approved
Date submitted
17/06/2025
Date registered
4/07/2025
Date last updated
4/07/2025
Date data sharing statement initially provided
4/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Digital Insomnia Treatment in the Australian Health System
Scientific title
Evaluating Clinician and Patient Engagement with a Digital Insomnia Treatment System for Adults in the Australian Health System
Secondary ID [1] 314635 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 337785 0
Condition category
Condition code
Neurological 334127 334127 0 0
Other neurological disorders
Public Health 334301 334301 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rationale: Cognitive behavioural therapy for insomnia (CBTi) is the recommended 'first line' treatment for insomnia (Qaseem et al., 2016, Ann Intern Med). Very few Australian patients with insomnia ever access CBTi (Miller et al., 2017, JCSM). This project aims to test the effectiveness of an online insomnia identification and triaging system and a digital CBTi intervention in Australian primary care settings.

Sleep Drive is an online insomnia identification, triaging, and management system that can be accessed by primary care practitioners and patients with insomnia. It includes an interactive insomnia screening-and-triaging tool, educational content for practitioners and patients, tailored recommendations for patients that require in-person care, a self-guided digital CBTi program (see below), and follow-up assessment and ongoing management recommendations.

Participating primary care practitioners will refer patients with suspected insomnia to Sleep Drive. Patients will complete the insomnia screening and triaging tool (approx 20 minutes). Underlying algorithms will assess for suspected insomnia and other sleep disorders, and provide recommendations for suitable management approaches to practitioners and patients. The online interactive screening and triaging tool includes questions about factors associated with the anticipated appropriateness of digital CBTi, versus clinician delivered CBTi. These broadly include questions about co-morbid conditions/risk factors, safety (e.g., contraindications for self-guided digital CBTi), suitability (e.g., access to internet-compatible device, English language comprehension), and effectiveness (e.g., shift workers that may require tailored treatment from a clinician) that are used by underlying algorithms to guide recommendations for digital CBTi, versus clinician-guided/delivered CBTi. Upon completion of the screening and triaging tool, patients and clinicians receive tailored outcomes, information, and recommendation/links to appropriate management options. Patients that are suitable for self-guided CBTi will be directed to a digital CBTi program (see below) and provided the opportunity to enrol in the clinical trial portion of this study.

Digital CBTi program: Bedtime Window.
Type: Non-drug, online, interactive.
Setting/location: Online, any location in Australia.
Duration: 5 x 20-30 minute online sessions, delivered over 5 consecutive weeks.
Protocol: Bedtime Window is a self-guided interactive digital CBTi program administered over 5 weekly 20-30 minute sessions. It has been validated in community and primary care samples with insomnia-alone and co-morbid insomnia and sleep apnoea (https://doi.org/10.1111/imj.16521; https://doi.org/10.1183/23120541.sleepandbreathing-2025.8).

Content of the 5 sessions includes tailored delivery of the following components;
1. Onboarding, program overview, sleep education, sleep hygiene information,
2. Factors that control timing and quality of sleep, behavioural sleep recommendations,
3. Behavioural sleep recommendations, education about sleep and anxiety,
4, Behavioural sleep recommendations, cognitive threapy, relaxation therapy, and
5. Behavioural sleep recommendations, tailored relapse prevention.

Content: Each session is administered online (computer or mobile phone). Each session contains videos, text, and images. Patients are asked to enter text-based, numerical (e.g. minutes of sleep duration) and multiple-choice data throughout the program. Participants receive tailored therapy recommendations during each weekly session. Immediately after each session is completed, participants will receive an automated follow-up email with session-specific 'follow-up' information and tailored therapy recommendations including recommended bedtime window (approximate reading time: 15 minutes). Participants will receive another automated email one week later with a link to start each subsequent session. Videos are presented by researchers, psychologists, and sleep technicians, each with extensive experience (>8 years) in the management of insomnia.

Tailoring / personalisation: Therapy recommendations will be tailored to participant's insomnia symptoms at baseline and weekly changes in symptoms throughout the program. Bedtime Restriction Therapy (initial restriction of time in bed to consolidate sleep, and subsequent gradual extension of time in bed) is a core component of CBTi. Bedtime restriction recommendations will be tailored to the specific sleep/wake information that participants provide.
Primary therapeutic components: Information about sleep, Bedtime restriction therapy, Stimulus Control Therapy.
Adherence assessment: Adherence will be defined as the number of participants commencing each of the 5 online sessions. This information is automatically collected through the online system.
Intervention code [1] 331256 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341782 0
Clinician-level outcome: Number of patients referred to Sleep Drive by participating clinicians.
Timepoint [1] 341782 0
Number of patients referred to the study by participating general practitioners per month of the study.
Primary outcome [2] 341781 0
Primary care clinician-level outcome: Clinician engagement (recruitment) to the study.
Timepoint [2] 341781 0
Number of clinicians recruited to the study per month of the study.
Secondary outcome [1] 449162 0
Patient-level outcome: Proportion of referred patients that are eligible for self-guided digital CBTi, versus referral to a clinician based on responses in the online screening and triaging tool.
Timepoint [1] 449162 0
Baseline
Secondary outcome [2] 448655 0
Patient-level outcome: Change in self-reported insomnia severity among patients eligible for Bedtime Window
Timepoint [2] 448655 0
Change in Insomnia Severity Index from baseline to 8-week, 16-week, and 24-week follow-up
Secondary outcome [3] 448656 0
Patient-level outcome: Change in self-reported depression severity among patients eligible for Bedtime Window
Timepoint [3] 448656 0
Change in Patient Health Questionnaire-9 from baseline to 8-week, 16-week, and 24-week follow-up
Secondary outcome [4] 448815 0
Patient-level outcome: Change in rate of medicine use for sleep (sleeping pills)
Timepoint [4] 448815 0
Change in proportion of patient self-reporting use of medicines for sleep from baseline to 8-week, 16-week, and 24-week follow-up
Secondary outcome [5] 449163 0
Patient-level outcome: Proportion of patients that commence digital CBTi program, Bedtime Window, that complete each of the 5 weekly sessions.
Timepoint [5] 449163 0
Peri-treatment (data drawn from Audit of Bedtime Window program, provided to patients between baseline and 8-week follow-up).

Eligibility
Key inclusion criteria
Clinician eligibility criteria:
1. Currently practicing as a AHPRA registered primary care clinician in Australia.

Patient inclusion criteria for digital CBTi clinical trial:
1. Aged 18 years or older
2. Referred by participating clinician
3. Insomnia Severity Index score of 8 or more (indicating at least Mild insomnia)
3. Reliable access to computer, tablet or smartphone, with internet access.
4. Basic English language comprehension as required for dCBTi program participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for digital CBTi clinical trial (the following parameters will also be assessed during the interactive screening-and-triaging questionnaire, and patients will be directed to appropriate in-person care):
1. No excessive daytime sleepiness (Epworth Sleepiness Scale score =>16).
2. None of the following psychiatric conditions; Bi-polar disorder, schizophrenia.
3. No risk of suicide (PHQ-9; item 9 score of greater than or equal to 1).
4. No Epilepsy.
5. Not currently pregnant.
6. No commercial drivers or people who operate heavy machinery for work.
7. No people with a cognitive impairment.
8. No shift-workers.
9. Previous sleepiness-related motor vehicle accident.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This trial will recruit Australian AHPRA registered primary care clinicians (e.g., general practitioners, psychologists, nurses, pharmacists) and the patients with suspected insomnia that they refer to this online insomnia management system; Sleep Drive.

Clinician-level analyses:
Primary endpoints will include rates of clinician engagement with the pathway (clinician completion of consent form, and rates of patient referrals over time).

Patient-level analyses:
Referred patients will be screened via Sleep Drive, and patients eligible for self-guided digital CBTi will be recruited to a single-arm trial. Intention to treat, Rates of patient engagement with Sleep Drive, completion of screening forms, triaging to digital CBTi (versus in-person management), and follow-up assessment completions will be studied. In patients that are suitable for digital CBTi and recruited to the clinical trial, mixed models will be used to investigate changes in insomnia symptoms and depression symptoms from baseline to 8-week, 16-week, and 24-week follow-up, rates of 'completion' of each of the 5-weekly sessions of Bedtime Window, and satisfaction feedback.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
1/01/2029
Actual
Date of last data collection
Anticipated
22/06/2029
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319196 0
University
Name [1] 319196 0
University of Western Australia
Country [1] 319196 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 321664 0
None
Name [1] 321664 0
Address [1] 321664 0
Country [1] 321664 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317778 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 317778 0
Ethics committee country [1] 317778 0
Australia
Date submitted for ethics approval [1] 317778 0
17/06/2025
Approval date [1] 317778 0
Ethics approval number [1] 317778 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142118 0
Dr Alexander Sweetman
Address 142118 0
School of Psychological Science, University of Western Australia, 35 Stirling Highway Perth, Crawley, Western Australia, 6009
Country 142118 0
Australia
Phone 142118 0
+08 6488 3141
Fax 142118 0
Email 142118 0
[email protected]
Contact person for public queries
Name 142119 0
Alexander Sweetman
Address 142119 0
School of Psychological Science, University of Western Australia, 35 Stirling Highway Perth, Crawley, Western Australia, 6009
Country 142119 0
Australia
Phone 142119 0
+08 6488 3141
Fax 142119 0
Email 142119 0
[email protected]
Contact person for scientific queries
Name 142120 0
Alexander Sweetman
Address 142120 0
School of Psychological Science, University of Western Australia, 35 Stirling Highway Perth, Crawley, Western Australia, 6009
Country 142120 0
Australia
Phone 142120 0
+08 6488 3141
Fax 142120 0
Email 142120 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No IPD sharing reason/comment: Not requested in participant information and consent forms (ethics).



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.