互联网认知行为疗法治疗失眠及互联网睡眠卫生教育对马来西亚医学生睡眠质量和执行功能的影响：一项随机对照试验方案

Effects of Internet Cognitive Behavioral Therapy for Insomnia and Internet Sleep Hygiene Education on Sleep Quality and Executive Function Among Medical Students in Malaysia: Protocol for a Randomized Controlled Trial.

作者信息

Mariappan Vijandran, Mukhtar Firdaus

机构信息

Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.

出版信息

JMIR Res Protoc. 2024 Dec 11;13:e59288. doi: 10.2196/59288.

DOI:10.2196/59288

PMID:39661437

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11669887/

Abstract

BACKGROUND

Medical students are frequently affected by poor sleep quality. Since poor sleep quality has negative physiological and psychological consequences such as on executive function, there is an opportunity to improve sleep quality and executive functions using non-pharmacological intervention such as cognitive behavioural therapy.

OBJECTIVE

The aim of this study therefore is to determine if improving sleep quality could improve executive functions in medical students with poor sleep quality by comparing cognitive behavioural therapy for insomnia (CBT-I) with sleep hygiene education (SHE) in a randomized controlled trial (RCT).

METHODS

A parallel group, RCT with a target sample of 120 medical students recruited from government-based medical universities in Malaysia. Eligible participants will be randomized to internet group CBT-I or internet group SHE in a 1:1 ratio. Assessments will be performed at baseline, post-intervention, 1 month, 3-months, and 6-months. The primary outcome is between-group differences in sleep quality and executive function post-baseline. The secondary outcomes include pre-sleep worry, attitude about sleep, sleep hygiene and sleep parameters.

RESULTS

This study received approval from the Research Ethics Committee in Universiti Putra Malaysia (JKEUPM-2023-1446) and Universiti Kebangsaan Malaysia (JEP-2024-669). The clinical trial was also registered in Australian New Zealand Clinical Trial Registry (ACTRN1264000243516). As of June 2024, the recruitment process is ongoing and a total of 48 and 49 students have been enrolled from the universities into the CBT-I and ISHE groups, respectively. All the participants provided signed and informed consent to participate in the study. Data collection has been completed for the baseline (pre-treatment assessment), and follow-up assessments for T1 and T2 for all the participants in both groups, while T3 and T4 assessments will be completed by July 2025. Data analysis will be performed by August 2025 and the research will be completed by December 2025.

CONCLUSIONS

This study is the first attempt to design a CBT intervention to ameliorate poor sleep quality and its related negative effects among medical students. This research is also the first large-scale exploring the relationship between health status and CBT-mediated sleep improvement among medical students.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry ACTRN12624000243516; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=387030.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/59288.

摘要

背景

医学生经常受到睡眠质量差的影响。由于睡眠质量差会产生负面的生理和心理后果，如对执行功能的影响，因此有机会通过认知行为疗法等非药物干预来改善睡眠质量和执行功能。

目的

因此，本研究的目的是通过在一项随机对照试验（RCT）中比较失眠认知行为疗法（CBT-I）与睡眠卫生教育（SHE），来确定改善睡眠质量是否能改善睡眠质量差的医学生的执行功能。

方法

一项平行组RCT，目标样本为120名医学生，从马来西亚的政府医学院招募。符合条件的参与者将按1:1的比例随机分为网络CBT-I组或网络SHE组。将在基线、干预后、1个月、3个月和6个月进行评估。主要结局是基线后两组在睡眠质量和执行功能方面的组间差异。次要结局包括睡前担忧、对睡眠的态度、睡眠卫生和睡眠参数。

结果

本研究获得了马来西亚博特拉大学（JKEUPM-2023-1446）和马来西亚国民大学（JEP-2024-669）研究伦理委员会的批准。该临床试验也已在澳大利亚新西兰临床试验注册中心注册（ACTRN1264000243516）。截至2024年6月，招募过程正在进行中，分别有48名和49名学生从两所大学被纳入CBT-I组和ISHE组。所有参与者均签署了知情同意书以参与本研究。两组所有参与者的基线（治疗前评估）以及T1和T2的随访评估的数据收集均已完成，而T3和T4评估将于2025年7月完成。数据分析将于2025年8月进行，研究将于2025年12月完成。