Spielman’s “3P” model) suggest that psychophysiological arousal caused by a stressful life event can cause a short-term disruption to sleep (i.e. Insomnia disorder (beyond 3 months) is associated with a significant economic burden and is a risk factor for a range of physical health conditions including hypertension, cardiovascular diseases and psychological conditions including depression. Therefore, insomnia is a highly prevalent problem. Within industrialised societies, approximately 6–10% of the population have insomnia, where prevalence rates have increased in recent years additionally, up to 48% of the population report the presence of insomnia symptoms. Insomnia is very common and is defined as dissatisfaction with sleep quantity, sleep quality, or both, due to difficulties initiating and/or maintaining sleep, for at least 3 nights per week, for a period of at least 3 months. Furthermore, the sponsor will have no role in the analysis and interpretation of the study results, in the writing of the report, or in the decision to submit the final report for publication. The funding source and study sponsor (Northumbria University) has had no role in the design of this study and will not have any role in the execution of the study. Name and contact information for the trial sponsor Ĭontact Address: Sutherland Building, Newcastle upon Tyne, NE1 8ST, United Kingdom Ellis (Northumbria Sleep Research, Northumbria University, Newcastle upon Tyne, UK) Elder, Nayantara Santhi, Pamela Alfonso-Miller, Jason G. The present study is funded by Northumbria University. Protocol version 1.1 (October 22 nd, 2021). ISRCTN43900695 prospectively registered on 8 th April 2020 Testing an early online intervention for the treatment of disturbed sleep during the COVID-19 pandemic in self-reported good and poor sleepers (Sleep COVID-19): study protocol for a randomised controlled trial ISRCTN43900695 (Prospectively registered 8th of April 2020). Specific advantages of online approaches include the low cost, ease of administration and increased availability of treatment, relative to face-to-face therapy. We expect that this will demonstrate the feasibility of online interventions for the treatment and prevention of acute insomnia. It is expected that this online intervention will reduce symptoms of acute insomnia in self-reported short-term poor sleepers, and will also prevent the transition to poor sleep in good sleepers. Data will be analysed using an intention-to-treat approach. Secondary outcome measures will include subjective mood and subjective sleep continuity, measured using sleep diaries. The primary outcome measure will be insomnia severity, measured using the Insomnia Severity Index. Participants will be followed up at 1 week (T5), 1 month (T6) and 3 months (T7) post intervention. All participants will complete a 1-week post intervention sleep monitoring period using daily sleep diaries (T4). Good sleepers ( n = 62) will be randomly assigned to an intervention or no intervention group. Poor sleepers ( n = 62) will be randomly allocated to an invention or wait-list group, where they will receive the intervention (T3), or will do so after a 28-day delay. After baseline assessments (T1), participants will complete a 1-week pre-intervention sleep monitoring period (T2) where they will complete daily sleep-diaries. MethodsĪ total of 124 self-reported good and poor sleepers will be enrolled in an online stratified randomised controlled trial. The objective of this study is to investigate if an online behavioural intervention, in the form of a leaflet, which has been successfully used alongside CBT-I for acute insomnia, can reduce symptoms of acute insomnia in poor sleepers. Further, online interventions can be used to deliver treatment to a large number of individuals. Although cognitive behavioural therapy for insomnia (CBT-I) is effective in treating insomnia disorder, this can be time and resource-intensive. Early interventions may prevent short-term sleep problems from progressing to insomnia disorder. Theoretical models of insomnia suggest that stressful life events, such as the COVID-19 pandemic, can cause acute insomnia (short-term disruptions to sleep).
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