Effectiveness of a guided digital self-help intervention to improve sleep and the biological clock in university students – Study protocol for a randomized controlled trial

IF 3.6 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES Internet Interventions-The Application of Information Technology in Mental and Behavioural Health Pub Date : 2024-08-02 DOI:10.1016/j.invent.2024.100763

Laura M. Pape , Annemieke van Straten , Sascha Y. Struijs , Philip Spinhoven , Niki Antypa

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Abstract

Background

Sleep problems occur in many university students which affects their mental health and daily functioning. Cognitive behavioural therapy for insomnia (CBT-I) has been proven effective in adults but research in university students, who struggle to maintain a 24-hour rhythm, is still limited. We hypothesize that a guided digital CBT-I intervention, enriched with components on the biological clock (‘i-Sleep & BioClock’) will be effective in reducing insomnia severity and improving mental health outcomes for students with sleep problems.

Objectives

We aim to evaluate the effectiveness of a guided online sleep and biological clock self-help intervention in improving sleep, depression symptoms, anxiety symptoms, functioning, academic performance, and quality of life in university students at 6 weeks and 18 weeks.

Methods

This is a two-arm parallel-group superiority randomized controlled trial, comparing a 5-week guided online ‘i-Sleep & BioClock’ intervention to online psychoeducation (PE). We aim to include 192 university students (Bachelor, Master, and PhD) with at least subthreshold insomnia (Insomnia Severity Index ≥10), aged ≥16, who can speak Dutch or English. We are excluding students with current risk for suicide or night shifts. The primary outcome is insomnia severity. Secondary outcomes include sleep estimates (sleep and light exposure diary), depression, anxiety, functioning, quality of life, and academic performance. The effectiveness of the intervention compared to online PE will be evaluated using linear mixed models.

Discussion

The current study tests the effectiveness of an online self-help intervention for university students who suffer from sleep problems. This trial builds upon an open feasibility study and will provide evidence of an online guided self-help program for students. The findings of this study will determine the potential wider dissemination of the intervention to address the high need for available and accessible help for students experiencing insomnia.

Trial registration

ClinicalTrials.Gov (NCT06023693), registered on August 3rd, 2023.

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改善大学生睡眠和生物钟的指导性数字自助干预措施的有效性--随机对照试验研究方案

背景许多大学生都有睡眠问题，这影响了他们的心理健康和日常工作。失眠认知行为疗法（CBT-I）已被证明对成年人有效，但对大学生的研究仍然有限，因为他们很难保持 24 小时的睡眠节奏。我们假定，在有指导的数字化 CBT-I 干预疗法（"i-Sleep & BioClock"）中加入有关生物钟的内容，将能有效降低失眠的严重程度，并改善有睡眠问题的学生的心理健康状况。方法这是一项双臂平行组优越性随机对照试验，将为期 5 周的在线 "i-Sleep & BioClock "指导性干预与在线心理教育（PE）进行比较。我们的目标是纳入 192 名至少患有亚阈值失眠症（失眠严重程度指数≥10）、年龄≥16 岁、能说荷兰语或英语的大学生（学士、硕士和博士）。我们排除了目前有自杀风险或上夜班的学生。主要结果是失眠严重程度。次要结果包括睡眠估计值（睡眠和光照日记）、抑郁、焦虑、功能、生活质量和学习成绩。将使用线性混合模型评估干预措施与在线PE相比的有效性。讨论本研究测试了针对有睡眠问题的大学生的在线自助干预措施的有效性。本试验建立在开放式可行性研究的基础上，将为学生提供在线指导自助计划的证据。这项研究的结果将决定该干预措施是否有可能得到更广泛的推广，以满足失眠学生对可获得的帮助的大量需求。试验注册ClinicalTrials.Gov（NCT06023693），注册日期为2023年8月3日。

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来源期刊

Internet Interventions-The Application of Information Technology in Mental and Behavioural Health Medicine-Health Informatics

CiteScore

6.50

自引率

9.30%

发文量

审稿时长

6 weeks

期刊介绍： Official Journal of the European Society for Research on Internet Interventions (ESRII) and the International Society for Research on Internet Interventions (ISRII). The aim of Internet Interventions is to publish scientific, peer-reviewed, high-impact research on Internet interventions and related areas. Internet Interventions welcomes papers on the following subjects: • Intervention studies targeting the promotion of mental health and featuring the Internet and/or technologies using the Internet as an underlying technology, e.g. computers, smartphone devices, tablets, sensors • Implementation and dissemination of Internet interventions • Integration of Internet interventions into existing systems of care • Descriptions of development and deployment infrastructures • Internet intervention methodology and theory papers • Internet-based epidemiology • Descriptions of new Internet-based technologies and experiments with clinical applications • Economics of internet interventions (cost-effectiveness) • Health care policy and Internet interventions • The role of culture in Internet intervention • Internet psychometrics • Ethical issues pertaining to Internet interventions and measurements • Human-computer interaction and usability research with clinical implications • Systematic reviews and meta-analysis on Internet interventions