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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000243516
Enrollment
120
Registered
2024-03-13
Start date
2025-02-01
Completion date
2025-06-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aims of this study is to determine if improving sleep quality could improve executive functions in medical students by comparing cognitive behavioral therapy for insomnia (CBT-I) with sleep hygiene education (SHE) in a randomised controlled trial (RCT). The primary hypotheses for the trial are that, compared to sleep hygiene education (SHE): 1. The ICBT intervention will be associated with improved sleep quality (SQ) after 1-month, 3-months and 6-months end of treatment. 2. The ICBT intervention will improve executive functioning (EF) after 1-month, 3-months and 6-months end of treatment. 3. The ICBT intervention will be associated with improve to total sleep time (TST), sleep onset latency (SOL), number of awakenings (NOA), wake time after sleep onset (WASO), and sleep efficiency (SE) after 1-month, 3-months and 6-months end of treatment. 4. The 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 (SQ) and sleep efficiency (SE).

Interventions

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 wi

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,

Sponsors

Vijandran A Mariappan
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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.).

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 5, 2026