Northumbria Sleep Research, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.
Trials. 2021 Dec 11;22(1):913. doi: 10.1186/s13063-021-05888-0.
Theoretical 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.
A 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.
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. 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.
ISRCTN43900695 (Prospectively registered 8th of April 2020).
失眠的理论模型表明，压力生活事件，如 COVID-19 大流行，可能导致急性失眠（短期睡眠中断）。早期干预可能防止短期睡眠问题发展为失眠症。尽管失眠认知行为疗法（CBT-I）在治疗失眠症方面有效，但这可能需要大量时间和资源。此外，在线干预可以用于向大量个体提供治疗。本研究的目的是调查一种在线行为干预形式，即已成功与 CBT-I 联合用于急性失眠的小册子，是否可以减轻睡眠质量差的人的急性失眠症状。
总共将有 124 名自我报告的睡眠良好和睡眠质量差的人参加一项在线分层随机对照试验。在基线评估（T1）后，参与者将完成为期 1 周的预干预睡眠监测期（T2），在此期间他们将完成每日睡眠日记。睡眠质量差的人（n=62）将被随机分配到发明或候补组，他们将在 T3 时接受干预，或者在 28 天后接受干预。睡眠质量好的人（n=62）将被随机分配到干预或不干预组。所有参与者将使用每日睡眠日记完成为期 1 周的干预后睡眠监测期（T4）。参与者将在干预后 1 周（T5）、1 个月（T6）和 3 个月（T7）进行随访。主要结局测量指标将是使用失眠严重程度指数测量的失眠严重程度。次要结局测量指标将包括使用睡眠日记测量的主观情绪和主观睡眠连续性。数据将采用意向治疗方法进行分析。
预计这种在线干预将减轻自我报告的短期睡眠质量差者的急性失眠症状，并防止睡眠质量好者转为睡眠质量差。我们预计这将证明在线干预治疗和预防急性失眠的可行性。在线方法的具体优势包括与面对面治疗相比，成本低、管理方便和治疗可及性增加。
ISRCTN43900695（于 2020 年 4 月 8 日前瞻性注册）。
