None listed
Conditions
Brief summary
Insomnia is a prevalent and debilitating disorder in Australia. The recommended treatment for insomnia is Cognitive Behavioural Therapy for insomnia (CBTi). However, there are very few clinicians in Australia with training in CBTi. Consequently, most patients with insomnia never access CBTi. 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 randomised controlled trial aims to investigate the effectiveness of a digital brief cognitive behavioural therpay for insomnia program, versus waitlist education control, on reducing insomnia symptoms in people with insomnia. It is hyopthesised that the group who receive the brief CBTi program will report a greater reduction in insomnia symptoms, compared to the group that receive education (waitlist control).
Interventions
Name: Digital Cognitive Behavioural Therapy for insomnia (dCBTi).
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 context.
Type: Non-drug, online, interactive.
Setting/location: Online, any location in Australia.
Name: Digital Cognitive Behavioural Therapy for insomnia (dCBTi). 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 context. 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: This program is based on CBTi, the recommended treatment for insomnia (e.g. Qaseem et al., 2016, Ann Intern Med, DOI: 10.7326/M15-2175). It is a digitised version of a brief CBTi protocol described in an scientific article in the Australian Journal of General Practice (Sweetman et al., 2021, AJGP, doi: 10.31128/AJGP-04-20-5391). Content: Each session will be administered online (computer or mobile phone). Each session will contain videos, text, and images. Participants will be asked to enter text-based, numerical (e.g. minutes of sleep duration) and multiple-choice data throughout the program. Participants will receive tailored therapy recommendations during each weekly session (see Sweetman et al., 2021, Aus J General Practice for tailored therapy recommendations). 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 Adelaide Institute for Sleep Health, Flinders University
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
Patient Inclusion Criteria 1. Adults aged great than or equal to 18 years. 2. Reliable access to computer, tablet or smartphone, with internet access 3. Basic English language comprehension as required for dCBTi program 4. An ISI score of at least 15 (Moderate insomnia)
Exclusion criteria
1. Psychiatric condition (Bi-polar disorder, schizophrenia) 2. Risk of suicide (PHQ-9; item 9 score of greater than or equal to 1) 3. Epilepsy 4. Currently pregnant 5. Drug or alcohol problem 6. Terminal illness 7. Moderate daytime sleepiness (Epworth Sleepiness Scale score equal to or more than 16) 8. People who are commercial drivers or operate heavy machinery for work 9. People with a cognitive impairment 10. Shift workers 11. Previous diagnosis of a sleep disorder other than insomnia 12. Previous sleepiness-related motor-vehicle accident Based on presenting symptoms, potential participants who are not eligible for this trial will be directed to a specialist Insomnia Treatment Program to access CBTi delivered by experienced 'sleep' Psychologists, or their general practitioner.
Outcome results
None listed