Digital insomnia treatment in Australian primary care

INTERVENTION: This randomised waitlist‐controlled implementation trial will investigate the feasibility and effectiveness of providing Australian general practitioners access to an online referral pathway, to refer their patients to an online Cognitive Behavioural Therapy for Insomnia (CBTi) program. General practitioners, and a selection of eligible patients they refer to the study will be recruited. Patients referred to the trial by general practitioners will undergo online screening and consent. Eligible patients will complete a baseline questionnaire battery before being randomised 1:1 to a 5‐session online CBTi program, or waitlist education‐control. Patients will complete outcome questionnaires at 8, 16, and 24 weeks. The waitlist control group will be provided access to the online CBTi program after the 8‐week follow‐up. With consent from patients, general practitioners will be provided a follow‐up report of patient progress at 8, 16, and 24 week follow‐up. GP follow‐up reports will be generated by the study team and will include participant‐level information on; the number of sessions completed, change in insomnia symptoms before and after treatment, sleeping pill use, and date of next follow‐up report. Information about the online CBTi program appears below. 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 a dCBTi intervention in the Australian general practice context. Type: Non‐drug, online, interactive. Setting/location: Online, any location in Australia. Duration: 5 X20 min CONDITION: Insomnia disorder; ; Insomnia disorder Mental Health ‐ Other mental health disorders Neurological ‐ Other neurological disorders PRIMARY OUTCOME: General practitioner‐level outcome:; General practitioner engagement (recruitment). These data will be collected by audit of study records (rates of online GP information and consent completion).[Number of general practitioners recruited to the trial per month of the study.] General practitioner‐level outcome:; Number of patients referred to trial by participating general practitioners. These data will be collected by audit of study referral records (rate of patient referrals over time through online referral website).[Number of patients referred to the study by participating general practitioners per month of the study.] Patient‐level outcome:; ; Between‐group change in self‐reported insomnia severity on the Insomnia Severity Index (ISI) questionnaire.[Between‐group change in ISI scores from baseline to 8‐week follow‐up (primary timepoint).; ; Change in ISI scores from baseline to 16‐week and 24‐week follow‐up in the CBTi group.] SECONDARY OUTCOME: Patient‐level outcome: ; Between‐group change in self‐reported depression symptoms on the Patient Health Questionnaire (PHQ‐9).[Between‐group change in PHQ‐9 scores from baseline to 8‐week follow‐up (primary timepoint). ; ; Change in PHQ‐9 scores from baseline to 16‐week and 24‐week follow‐up in the CBTi group.] INCLUSION CRITERIA: General practitioner INCLUSION CRITERIA: 1. Currently practicing as a general practitioner in Australia. Patient INCLUSION CRITERIA: 1. Aged at least 18 2. Referred by participating GP. 3. Reliable access to computer, tablet or smartphone, with internet access. 4. Basic English language comprehension as required for dCBTi program participation.