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

Not Applicable

• Conditions: Poor sleep quality; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12624000243516
• Lead Sponsor: Vijandran A Mariappan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-13
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep quality [The Pittsburgh Sleep Quality Index 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.<br><br><br>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. ];Executive function[Digital trail making test 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.<br><br>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. ]