Category
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Primary study
Registry of Trials»ANZCTR
Year
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2024
INTERVENTION: 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, CONDITION: Mental Health ‐ Studies of normal psychology, cognitive function and behaviour Poor sleep quality; ; Poor sleep quality PRIMARY OUTCOME: 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.; ; 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. ] 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.; ; ; 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. ] 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.). SECONDARY OUTCOME: Pre‐sleep Arousal[Presleep Arousal Scale 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.] Sleep Hygiene [Sleep Hygiene Inde XBaseline 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.] 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.[Pittsburgh Sleep Quality Inde Xwill be used to prospectively derive sleep quality. ; ; 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.] 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)[Sleep diary 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.] Sleep‐disruptive cognitions[The Dysfunctional Beliefs and Attitudes about Sleep‐16 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.]
Epistemonikos ID: cd12258897aba786289c585a6bbcab82f80acaa9
First added on: Aug 28, 2024