None listed
Conditions
Brief summary
Cognitive Behavioural Therapy for insomnia (CBTi) is the recommended 'first line' treatment for insomnia in Australia, but is accessed by only 1% of people with insomnia. To improve access and use of CBTi in Australia, we have developed a software-assisted insomnia screening, traiging, education, and management system named Sleep Drive. Sleep Drive includes an evidence-based self-guided digital CBTi program "Bedtime Window" that will be made freely available to suitable patients in this study via an embedded clinical trail. We aim to investigate the feasibility, and acceptability of Sleep Drive in Australian primary care, and the effectiveness of Bedtime Window in a sub-sample of participants eligible for the clinical trial. It is hypothesised that Sleep Drive will be a feasible and acceptable intervention in Australian primary care that will improve access to CBTi. It is hypothesised that patients recruited to the clinical trial of Bedtime Window will experience large post-treatment improvements in symptoms of insomnia and depression, and reduced use of sleeping pills that are sustained by 24-week follow-up. Feasibility; • It is hypothesised that GPs, psychologists, pharmacists, and nurses in all Australian states/territories, and from rural, remote, and metropolitan locations will engage with Sleep Drive and refer patients, and that there will be an increasing number of clinicians that register for the trial per month of the study. • It is hypothesised that there will be an increasing number of patient referrals to Sleep Drive per quarter of the study. • Qualitative feedback from patients and clinicians will indicate that Sleep Drive is feasible in the Australian primary care system (free-text qualitative feedback opportunities at key points in the Sleep Drive ecosystem). Acceptability; • At least 70% of patients that complete screening forms will be eligible for Bedtime Window. • At least 60% of patients provided access to Bedtime Window will complete the 5-session program. • At least 95% of patients completing Bedtime Window will indicate high-very high levels of satisfaction and acceptability. • Qualitative feedback from patients and clinicians will indicate high levels of acceptability of Sleep Drive in Australian primary care. Effectiveness will be defined as; • In participants provided access to Bedtime Window and recruited to the clinical trial: Change from baseline to 8-weeks, 16-weeks, and 24-weeks in measures of insomnia (Insomnia Severity Index), depression (PHQ9), current overall health, and reduced sleeping pill use (self-reported use of medicines for sleep at each follow-up).
Interventions
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 tha
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.
Sponsors
The University of Western Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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 or breastfeeding. 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.
Outcome results
None listed