Abstract
BackgroundTheoretical models of insomnia suggest that stressful life events, such as the COVID-19 pandemic, can cause acute insomnia (short-term disruptions to sleep). Early interventions may prevent short-term sleep problems from progressing to insomnia disorder. Although cognitive behavioural therapy for insomnia (CBT-I) is effective in treating insomnia disorder, this can be time and resource-intensive. Further, online interventions can be used to deliver treatment to a large number of individuals. 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.MethodsA total of 124 self-reported good and poor sleepers will be enrolled in an online stratified randomised controlled trial. After baseline assessments (T1), participants will complete a 1-week pre-intervention sleep monitoring period (T2) where they will complete daily sleep-diaries. 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. Good sleepers (n = 62) will be randomly assigned to an intervention or no intervention group. All participants will complete a 1-week post intervention sleep monitoring period using daily sleep diaries (T4). Participants will be followed up at 1 week (T5), 1 month (T6) and 3 months (T7) post intervention. The primary outcome measure will be insomnia severity, measured using the Insomnia Severity Index. Secondary outcome measures will include subjective mood and subjective sleep continuity, measured using sleep diaries. Data will be analysed using an intention-to-treat approach.DiscussionIt 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. We expect that this will demonstrate the feasibility of online interventions for the treatment and prevention of acute insomnia. Specific advantages of online approaches include the low cost, ease of administration and increased availability of treatment, relative to face-to-face therapy.Trial registrationISRCTN43900695 (Prospectively registered 8th of April 2020).
Highlights
Background and rationale {6a} 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 [1]
The main objective of this online randomised controlled trial is to investigate the effectiveness of a web-based behavioural intervention for poor sleep in the context of the ongoing COVID-19 pandemic
Secondary objectives of this trial will include assessing if the intervention can improve subjective anxiety, depression and sleep continuity in poor sleepers, and if the intervention can prevent good sleepers from developing acute insomnia
Summary
Background and rationale {6a} 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 [1]. Theoretical models of insomnia (e.g. Spielman’s “3P” model) suggest that psychophysiological arousal caused by a stressful life event can cause a short-term disruption to sleep (i.e. acute insomnia) [8, 9]. Over time, this can result in maladaptive compensatory behaviours, such as spending excessive time in bed or becoming preoccupied with sleep, which creates a long-term problem of poor sleep through behavioural conditioning [10]. Theoretical models of insomnia suggest that stressful life events, such as the COVID-19 pandemic, can cause acute insomnia (short-term disruptions to sleep). Interventions may prevent short-term sleep problems from progressing to insomnia disorder. 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
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