None listed
Conditions
Brief summary
Insomnia is a prevalent and debilitating disorder in Australia. Cognitive behavioural therapy for insomnia (CBTi) is the recommended 'first line' treatment for insomnia (Qaseem et al., 2016, Ann Intern Med). However, there are very few clinicians in Australia with training in CBTi. Consequently, most patients with insomnia never access CBTi (Miller et al., 2017, JCSM). This project aims to test the effectiveness of a dCBTi intervention in the Australian general practice context. Self-guided and clinician-guided digital CBTi programs are an effective and potentially scalable intervention to manage insomnia. There are very few evidence-based digital CBTi programs available in Australia, and currently no publicly-available digital CBTi programs that provide personalised weekly behavioural therapy recommendations. This cluster randomised controlled implementation trial aims to investigate the effectiveness of three digital treatment options for insomnia in Australian general practice. Following recruitment of eligible patients with insomnia symptoms, general practice clinics will be cluster-randomised 1:1:1 to; 1. Digital sleep hygiene education (treatment as usual control) 2. Self-guided digital cognitive behavioural therapy for insomnia program 3. Clinician-guided digital cognitive behavioural therapy for insomnia program (digital program plus three sessions with general practitioner to provide guidance and motivational support). It is hyopthesised that the groups that receive the digital CBTi program will report a greater reduction in insomnia and depressive symptoms and lower rates of medicine use for insomnia, compared to the group that receive sleep education (control). Furthermore, it is hypothesised that the group that receive clinician-guided digital CBTi will experience greater reduction of insomnia and depressive symptoms, and lower rates of medicine use for insomnia compared to the group that receive self-guided digital CBTi.
Interventions
This three-arm cluster randomised controlled implementation trial will investigate the effectiveness of three digital treatment approaches for insomnia in Australian general practice.
42 general practice clinics (predominantly in rural and regional locations) will be recruited. General practitioners in participating clinics will be invited to identify and recruit a total of 294 patients with insomnia symptoms to the trial (7 patients per clinic). Patients will be invited to complete online cons
This three-arm cluster randomised controlled implementation trial will investigate the effectiveness of three digital treatment approaches for insomnia in Australian general practice. 42 general practice clinics (predominantly in rural and regional locations) will be recruited. General practitioners in participating clinics will be invited to identify and recruit a total of 294 patients with insomnia symptoms to the trial (7 patients per clinic). Patients will be invited to complete online consent and screening forms, and a baseline questionnaire battery. Eligibility will be confirmed by research personnel prior to patient recruitment to the trial. Following recruitment of 7 patients with insomnia per clinic, general practice clinics (and patients belonging to that clinic) will be randomly allocated to one of three groups. To reduce delays between patient recruitment and randomisation, clinics will be randomised in blocks of 6 as they complete practice recruitment; Study groups: 1. Digital sleep health education (augmented treatment as usual control) 2. Self-guided digital cognitive behavioural therapy for insomnia program 3. Clinician-guided digital cognitive behavioural therapy for insomnia program (digital program plus three consultations with the general practitioner). Patients will complete a self-report online outcome questionnaire battery at baseline (before clinic randomisation), 10-weeks, and 6-months post-randomisation. Information about the online CBTi program appears below. Type: Non-drug, online, interactive. Setting/location: Online, any location in Australia. Duration: 5 x 20 minute online sessions, delivered over 5 consecutive weeks. Protocol: CBTi is the recommended 'first line' treatment for insomnia (e.g. Qaseem et al., 2016, Ann Intern Med, DOI: 10.7326/M15-2175). However, the majority of people with insomnia in Australia do not access CBTi (DOI: 10.5664/jcsm.6616). Digital CBTi programs may offer an effective and feasible solution to improve access to CBTi. The digital CBTi program "Bedtime Window" will be used (DOI: 10.3389/frsle.2024.1355468). Bedtime Window is a 5-session interactive digital CBTi program. Each session will be administered online (computer or mobile phone). Each session will contain 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 (DOI: 10.3389/frsle.2024.1355468). 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 insomnia and sleep/wake symptoms throughout the program. Patients in the third study group will additionally receive three consultations with their general practitioner during the 5-week period that they are completing the program. Three consultations with a general practitioner are expected to last for approximately 10-15 minutes each. These consultations are expected to be delivered alongside completion of sessions 1, 2, and 4 of the digital program (or as close as possible to completion of these sessions). During consultations, general practitioners will provide onboarding and tailored sleep assessment support, reinforce concepts and provide motivational support to encourage adherence to recommendations of the digital program, identify and overcome barriers to completion of the digital program, and support any changes to sedative-hypnotic use. Adherence to these consultations will be monitored through clinical electronic medical records. Primary therapeutic components: Information about sleep, Bedtime restriction therapy, Stimulus control therapy, Relaxation therapy, Cognitive re-focusing, and Relapse prevention. 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
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General practitioner inclusion criteria; 1. Currently practicing as a general practitioner in Australia. Patient inclusion criteria; 1. Aged at least 18 years 2. Referred by a participating general practitioner, according to GP-identified insomnia symptoms, general practice electronic medical record notes identifying diagnosis or clinical problem of insomnia lasting at least 3 months, and prescription of sedatives or hypnotics for insomnia symptoms 3. Reliable access to a computer, tablet, or smartphone with internet access. 4. Basic English language comprehension as required for CBTi program participation. 5. Active patients of the participating general practice clinic (have attended at least 3 times in the last two years). 6. Insomnia symptoms according to an Insomnia Severity Index score of at least 15, that have persisted for at least 3 months (indicative of chronic insomnia)
Exclusion criteria
1. Doctor-diagnosed sleep disorders other than insomnia (e.g. sleep apnoea, narcolepsy). 2. Excessive daytime sleepiness (Epworth Sleepiness Scale Score >15). 3. Current psychological treatment for insomnia, 4. Shift work within the past 3 months, 5. Significant cognitive impairment, terminal illness, severe psychiatric condition (e.g., bipolar disorder or schizophrenia disorder), or epilepsy. 6. Currently pregnant. 7. Previous sleepiness-related motor-vehicle accident. 8. Driver, pilot, or operates heavy machinery for work. 9. No self-reported risk of self-harm (identified by a score of greater than or equal to 1 on the PHQ-9, item 9).
Outcome results
None listed