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

BackgroundMedical 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-pharm...

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Main Authors: Vijandran Mariappan, Firdaus Mukhtar
Format: Article
Language:English
Published: JMIR Publications 2024-12-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2024/1/e59288
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author Vijandran Mariappan
Firdaus Mukhtar
author_facet Vijandran Mariappan
Firdaus Mukhtar
author_sort Vijandran Mariappan
collection DOAJ
description BackgroundMedical 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. ObjectiveThe 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). MethodsA 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. ResultsThis 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. ConclusionsThis 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 RegistrationAustralian 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
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spelling doaj-art-f90527e2e1214298a33b120c31ed020e2024-12-11T16:00:47ZengJMIR PublicationsJMIR Research Protocols1929-07482024-12-0113e5928810.2196/59288Effects 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 TrialVijandran Mariappanhttps://orcid.org/0009-0007-0017-6697Firdaus Mukhtarhttps://orcid.org/0000-0001-8766-6929 BackgroundMedical 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. ObjectiveThe 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). MethodsA 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. ResultsThis 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. ConclusionsThis 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 RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12624000243516; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=387030 International Registered Report Identifier (IRRID)PRR1-10.2196/59288https://www.researchprotocols.org/2024/1/e59288
spellingShingle Vijandran Mariappan
Firdaus Mukhtar
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
JMIR Research Protocols
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://www.researchprotocols.org/2024/1/e59288
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