None listed
Conditions
Brief summary
The purpose of this research is to further examine the efficacy of the Sleep Course, a brief, cognitive behavioural therapy intervention for insomnia (CBT-I). In previous research, the Sleep Course and similar interventions have shown they are safe and effective for diverse groups of people with insomnia. However, we do not know which components are associated with the most benefit, or how people's symptoms improve during the course of treatment. The aim of this study is to examine participants' symptoms more closely as they take part in treatment, to understand when they experience benefit. We expect that participants will demonstrate significant improvement in their insomnia and associated symptoms, and that much of this improvement will be experienced in early weeks of the treatment. Participants (adults with insomnia symptoms) will be randomised to receive either the Sleep Course (digital CBT-I intervention) or a brief sleep hygiene waitlist control. While in the intervention, participants will have access to the Sleep Course along with clinical support from a psychologist. Both groups will complete measures of their symptoms during the treatment phase.
Interventions
The intervention, the Sleep Course, is a digital psychological self-management program. It is based on the principles of cognitive behavioural therapy for insomnia (CBT-I). It runs for 8 weeks and consists of:
(a) 4 online lessons with exercises for learning the information and skills. The duration of each lesson is approximately 20 to 30 minutes. Lessons are completed in weeks 2, 3, 5, and 7. Lessons can be viewed in the online platform or downloaded as PDF files. Lessons are delivered via an o
The intervention, the Sleep Course, is a digital psychological self-management program. It is based on the principles of cognitive behavioural therapy for insomnia (CBT-I). It runs for 8 weeks and consists of: (a) 4 online lessons with exercises for learning the information and skills. The duration of each lesson is approximately 20 to 30 minutes. Lessons are completed in weeks 2, 3, 5, and 7. Lessons can be viewed in the online platform or downloaded as PDF files. Lessons are delivered via an online learning management system in the form of powerpoint-style lessons (i.e., written materials and supporting images). Lessons can also be downloaded as PDFs. Lessons are accompanied by DIY lesson worksheets which can be downloaded and/or printed as PDF files. Participants are encouraged to engage with the home-based exercises at a frequency and duration that is helpful for them, though a suggested time commitment of at least 30 minutes each week is encouraged. In the first week of the course, participants will receive a welcome email that provides log-in details and requests that participants complete a sleep diary each night for 7 nights. No therapeutic material is released while participants complete their sleep diaries. The first lesson (in week 2) is an introduction to the course and overview of the key processes that govern sleep-wake cycles. This includes the circadian rhythm (or body clock) and the sleep pressure system. Participants are encouraged to consider the relevance of these two systems for their unique situation as a home-based exercise. Lesson 2 (week 3) introduces two key behavioural methods to improve sleep – stimulus control and sleep restriction therapy. Participants are also provided with a decision-making tool to determine which strategy they may use. As home-based exercise, participants are encourage to start practicing one of these skills for the next two weeks. Lesson 3 (week 5) introduces the cognitive behavioural model, and explores how thinking processes and appraisals can influence sleep. For their home-based exercises, participants are encouraged to practice cognitive challenging skills. Finally, Lesson 4 (week 7) introduces strategies to manage sleep difficulties during the day. It covers the importance of helpful daytime habits to promote sleep at night, including overcoming sleep inertia, remaining active during the day, and implementing a wind-down routine. Participants are encouraged to experiment with symptoms of fatigue as home-based work, as well as to introduce wake-up and wind-down routines. Participants are able to access the course materials during the post-treatment phase, as well as for 3 months after completing the course. (b) Automatic emails that help guide people through the course. Examples of these e-mails include; reminders when new lessons are available, congratulatory messages once a lesson has been completed, brief messages that reinforce the core concepts of the lessons, and e-mails inviting contact and encouraging engagement if a participant has not logged in for a while. E-mails are sent approximately once per week. (c) Additional Resources developed specifically for this study, which are available for download as PDF files. These resources provide information about different problems relevant to people with sleep difficulties. These include understanding more about prescription sleeping medications, managing shift-work, information about nightmares, and managing worry and rumination. The additional resources are made available on the course homepage for download. In each lesson, the introductory slides (e.g., 'overview of this lesson' contains a brief text box that provides detail about what is in the additional resources). Participants will also have the option of support from a psychologist as they work through the course, either via telephone or secure personal messaging. Course psychologists will contact participants via secure message in the first week of the course, to obtain participant preferences regarding the frequency and nature of contact. After this point, psychologists will tailor their communication to the participants' preferences. All psychologists will be nationally registered and employed by Macquarie University or one of its entities (e.g., MQ Health). All psychologists will be provided with training and supervision from a senior clinical psychologist to ensure competence and safety in their practice. Adherence with the intervention is monitored via the study's secure web platform, which records information such as; the number of participant log-ins, lesson completions; time spent completing each lesson; and number of downloads of additional resources.
Sponsors
Macquarie 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
1. Currently living in Australia 2. Aged 18 or older 3. Report clinically significant insomnia: symptoms on the ISI > 10, duration > 1 month and report that the difficulties are causing distress or causing the individual problems at work, socially, or in another important way.
Exclusion criteria
1. Current severe medical or psychiatric disorder that requires medical treatment (e.g., current active substance use disorder, mania or psychosis, actively suicidal or unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment) 2. Evidence of an undiagnosed and untreated sleep disorder (e.g., restless legs syndrome, sleep apnoea) that is the primary cause of insomnia symptoms. 3. Actively suicidal or unable to keep themselves safe. 4. Unable to read and understand English.
Outcome results
None listed