Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000243516
Ethics application status
Approved
Date submitted
11/12/2023
Date registered
13/03/2024
Date last updated
13/03/2024
Date data sharing statement initially provided
13/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet cognitive behavioural therapy for insomnia versus internet sleep hygiene education: The impact of improving sleep quality on executive function among public medical students in Malaysia: Randomised controlled trial
Scientific title
A randomised controlled trial comparing the effect of internet cognitive behavioural therapy versus internet sleep hygiene education on sleep quality and executive function amongst public medical students in Malaysia
Secondary ID [1] 311150 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor sleep quality 332315 0
Condition category
Condition code
Mental Health 329024 329024 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Cognitive Behavioural Therapy for Insomnia (CBT-I) involves 6 weekly online group interaction sessions with a CBT-I trained clinical psychologist. Each session will consist of 28 participants.

Each session will last 45 to 60 minutes.

Session 1 will involve psychoeducation about sleep regulation.
Session 2 will involve sleep restriction.
Session 3 will involve sleep hygiene and stimulus control.
Session 4 will involve Progressive Muscle Relaxation (PMR) based on Jacobson.
Session 5 will involve cognitive restructuring.
Session 6 will involve relapse prevention.


All treatments adherence in the CBT-I will be monitor by online attendance on the paid zoom platform and all participants will be required to switch on their web camera. Short online quizzes will also be periodically provided on each session to ensure all participants are active and understanding the content of the session objective,
Intervention code [1] 327592 0
Behaviour
Comparator / control treatment
The Sleep Hygiene Education (SHE) involves 6 weekly online group interaction sessions with a clinical psychologist (who is separate from the Cognitive Behavioural Therapy for Insomnia sessions). Each session will consist of 28 participants. Each session will last 45 to 60 minutes.

Session 1 will involve psychoeducation about sleep regulation.
Session 2 will involve sleep hygiene I (light, sound, temperature).
Session 3 will involve sleep hygiene II (exercise, food, alcohol/nicotine/caffeine)
Session 4 will involve Progressive Muscle Relaxation (PMR) based on Jacobson.
Session 5 will involve stress management and sleep.
Session 6 will involve treatment evaluation and maintenance.

All treatments adherence in the SHE will be monitor by online attendance on the paid zoom platform and all participants will be required to switch on their web camera. Short online quizzes will also be periodically provided on each session to ensure all participants are active and understanding the content of the session objective,
Control group
Active

Outcomes
Primary outcome [1] 336832 0
Sleep quality
Timepoint [1] 336832 0
Baseline measurements will be administered 1 week before the intervention. Post intervention will be administered on week 6 (after session 6) and follow up measurements will be administered 1-month post intervention, 3-months post intervention, and 6-months post intervention.


There will be no weekly assessments except for sleep daily submission which begins 2 weeks prior the intervention in both the CBT-I and SHE groups.
Primary outcome [2] 336833 0
Executive function
Timepoint [2] 336833 0
Baseline measurements will be administered 1 week before the intervention. Post intervention will be administered on week 6 (after session 6) and follow up measurements will be administered 1-month post intervention, 3-months post intervention, and 6-months post intervention.

There will be no weekly assessments except for sleep daily submission which begins 2 weeks prior the intervention in both the CBT-I and SHE groups.
Secondary outcome [1] 429769 0
Sleep parameters as a composite outcome are total sleep time (TST), sleep onset latency (SOL), number of awakenings (NOA), wake time after sleep onset (WASO), sleep quality (SQ), and sleep efficiency (SE; calculated by TST/time in bed × 100)

Sleep parameters will be measured when sleep diaries are provided by participants during each sessions from 2 weeks prior intervention until session 6. Then sleep diary will be requested at 1-month post intervention, 3-months post intervention, and 6-months post intervention.
Timepoint [1] 429769 0
Baseline measurements will be administered 1 week before the intervention. Post intervention will be administered on week 6 (after session 6) and follow up measurements will be administered 1-month post intervention, 3-months post intervention, and 6-months post intervention.
Secondary outcome [2] 429770 0
Sleep-disruptive cognitions
Timepoint [2] 429770 0
Baseline measurements will be administered 1 week before the intervention. Post intervention will be administered on week 6 (after session 6) and follow up measurements will be administered 1-month post intervention, 3-months post intervention, and 6-months post intervention.
Secondary outcome [3] 429771 0
Pre-sleep Arousal
Timepoint [3] 429771 0
Baseline measurements will be administered 1 week before the intervention. Post intervention will be administered on week 6 (after session 6) and follow up measurements will be administered 1-month post intervention, 3-months post intervention, and 6-months post intervention.
Secondary outcome [4] 429772 0
Sleep Hygiene
Timepoint [4] 429772 0
Baseline measurements will be administered 1 week before the intervention. Post intervention will be administered on week 6 (after session 6) and follow up measurements will be administered 1-month post intervention, 3-months post intervention, and 6-months post intervention.
Secondary outcome [5] 432662 0
Sleep parameters composite are total sleep time (TST), sleep onset latency (SOL), number of awakenings (NOA), wake time after sleep onset (WASO), sleep quality (SQ), and sleep efficiency (SE; calculated by TST/time in bed × 100)
Timepoint [5] 432662 0
Sleep parameters will be measured when sleep diaries are provided by participants during each sessions from 2 weeks prior intervention until session 6. Then sleep diary will be requested at 1-month post intervention, 3-months post intervention, and 6-months post intervention.

Eligibility
Key inclusion criteria
Met all of the following criteria:

1. Individuals are 18 years or older;
2. Currently a medical students in Klang Valley, Selangor and living in Malaysia;
3. Willing and able to provide written informed consent;
4. Being able to read and understand English;
5. Have reliable Internet access at home or at university;
6. Proficiency (self-reported) in basic computer/internet skills (as required to participate in the RCT and complete online assessments, etc.).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Met one or more of the following criteria:

1. Evidence of a sleep disorder (e.g., possible obstructive sleep apnoea, restless legs syndrome;
2. Currently consumes alcohol;
3. Medical history contraindicating use of CBT-I, for example, (a) epilepsy (self-report) within the preceding 12 months, or (b) recent cardiac surgery, or (c) currently in an attack phase of multiple sclerosis;
4. Individuals whose work schedule includes night shifts;
5. Pregnancy;
6. Inadequate opportunity to sleep or living circumstances that prevent modification of sleep pattern (e.g., having an infant residing at home);
7. Currently receiving psychological treatment for insomnia;
8. Registered at or under the care of any of the trial centres;
9. Serious physical health concerns necessitating surgery or with a prognosis of under 6 months;
10. Those taking prescribed sleeping pills more than 2 nights in the past 2 weeks prior to study entry; and
11. Those with suicidal ideation with intent. This study will not omit participants for any other physical or mental health problems.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants in the inclusion in the trial will be unaware of the group being allocated to.
Allocation will be concealed by simple randomisation by computer by independent administrator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data will be analysed using the IBM SPSS version 22. Descriptive statistics of recruitment, dropout and completeness of interventions will be provided. The main efficacy analysis will be via intention-to- treat including all participants, with no planned interim analysis for efficacy or futility. Baseline characteristics will be presented by randomised group without formal statistical tests.


All participants’ data will be summarised using descriptive statistics and presented either as means and standard deviation or median and interquartile range depending on the normality tests. Data distribution will be checked using the Shapiro-Wilk test. Meanwhile, categorical variables will be presented as frequencies and percentages.

To test treatment effects, repeated measures ANOVAs with 2 (ICBT-I, ISHE) X 2 (baseline, post-treatment) will examine Treatment x Time interactions for changes in sleep quality (EQ), executive functioning (EF), total sleep time (TST), time in bed (TIB), sleep efficiency (SE) calculated by TST/time in bed × 100), sleep onset latency (SOL), number of awakenings (NOA), wake time after sleep onset (WASO), dysfunctional belief about sleep, presleep arousal and sleep hygiene index, at four points: (1) baseline to post-treatment; (2) baseline to 1-month post-treatment, (3) baseline to 3-months post-treatment; and (4) baseline to 6-months post-treatment.

After testing for Treatment x Time interaction effects, paired samples t-tests will be conducted within each condition to test for potential simple effects; significant results and statistical trends were then followed-up with Cohen’s d estimation of effect size specifically designed for paired samples t-tests, which accounts for the correlation between the pre-and posttreatment values (Morris & DeShon, 2002).


In addition to the one-way ANOVAs, a posthoc comparisons will also be used to compare mean levels for each treatment outcome to determine differences in sleep quality (EQ), executive functioning (EF), total sleep time (TST), time in bed (TIB), sleep efficiency (SE) calculated by TST/time in bed × 100), sleep onset latency (SOL), number of awakenings (NOA), wake time after sleep onset (WASO), dysfunctional belief about sleep, presleep arousal and sleep hygiene index symptoms levels across groups. Finally, to examine Hypothesis 4, mediator analyses will be conducted to explore whether dysfunctional beliefs and attitudes about sleep, pre-sleep worry, and sleep hygiene will be significantly mediators the treatment effects of CBT-I on sleep quality and sleep efficiency. In a single mediation analyse will be conducted with the pre-post change scores of the PSQI scores with sleep efficiency (SE) as dependent variables. The pre-to-post change scores of the dysfunctional beliefs (DBAS), and pre- sleep arousal (PSAS) will be included as mediator variables similar to the similar study (Lancee et al., 2019).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment outside Australia
Country [1] 26026 0
Malaysia
State/province [1] 26026 0
Selangor

Funding & Sponsors
Funding source category [1] 315806 0
Self funded/Unfunded
Name [1] 315806 0
Vijandran A Mariappan
Country [1] 315806 0
Malaysia
Primary sponsor type
Individual
Name
Vijandran A Mariappan
Address
Faculty of Medicine & Health Science Department of Psychiatry Universiti Putra Malaysia 43400 Serdang Selangor
Country
Malaysia
Secondary sponsor category [1] 317932 0
None
Name [1] 317932 0
Address [1] 317932 0
Country [1] 317932 0
Other collaborator category [1] 282890 0
University
Name [1] 282890 0
University Putra Malaysia (UPM)
Address [1] 282890 0
Faculty of Medicine & Health Science Department of Psychiatry Universiti Putra Malaysia 43400 Serdang Selangor
Country [1] 282890 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314321 0
University Putra Malaysia
Ethics committee address [1] 314321 0
Ethics committee country [1] 314321 0
Malaysia
Date submitted for ethics approval [1] 314321 0
06/12/2023
Approval date [1] 314321 0
26/02/2024
Ethics approval number [1] 314321 0
UPM/TNCPI/RMC/JKEUPM/1.4.18.2 (JKEUPM)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131178 0
Mr Vijandran A Mariappan
Address 131178 0
Faculty of Medicine & Health Science Department of Psychiatry Universiti Putra Malaysia 43400 Serdang Selangor
Country 131178 0
Malaysia
Phone 131178 0
+60162210132
Fax 131178 0
Email 131178 0
[email protected]
Contact person for public queries
Name 131179 0
Vijandran A Mariappan
Address 131179 0
Faculty of Medicine & Health Science Department of Psychiatry Universiti Putra Malaysia 43400 Serdang Selangor
Country 131179 0
Malaysia
Phone 131179 0
+60162210132
Fax 131179 0
Email 131179 0
[email protected]
Contact person for scientific queries
Name 131180 0
Dr. Firdaus Mukhtar
Address 131180 0
Faculty of Medicine & Health Science Department of Psychiatry Universiti Putra Malaysia 43400 Serdang Selangor
Country 131180 0
Malaysia
Phone 131180 0
+60123026353
Fax 131180 0
Email 131180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21169Informed consent form    387030-(Uploaded-11-12-2023-04-11-59)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.