Cracking the Code to Better Sleep: A Pioneering Study on Remote Support for Insomnia Relief - Trial NCT06211075

Timeline & Enrollment

Primary Outcome

Enrollment rate,Eligibility rate,Attrition,Change in Insomnia Severity Index (ISI),Change in Sleep Condition Indicator (SCI),Adherence

Summary

The goals of this clinical trial are to assess the feasibility of an internet-based Cognitive
 Behavioral Therapy for Insomnia (CBT-I) and Motivation Interviewing (MI) intervention for
 individuals aged 18 to 64 with mild to moderate insomnia, and/or mild anxiety/depression. The
 main questions it aims to answer are:
 
 - Can internet-based CBT-I effectively improve sleep quality and reduce insomnia symptoms?
 
 - Can internet-based CBT-I effectively improve sleep efficiency, sleep onset latency
 (SOL), and wake after sleep onset (WASO)?
 
 - Is CBT-I treatment feasible to carry out remotely? What are the percentages of
 participants who dropped out of the study?
 
 - Is internet-based CBT-I financially feasible compared to the traditional CBT-I
 intervention?
 
 Eligible participants would be invited to participate in the research and randomised into two
 groups: Intervention and Waitlist Control. Both groups will have their baseline Insomnia
 Severity Index and Sleep Condition Indicator assessed prior to the main part of the research.
 
 Participants in the Intervention group will go through 4 CBT-I sessions over the course of 4
 weeks. These sessions will be delivered online by trained lay-person coaches, supervised
 directly by an experienced coach specialising in CBT-I. The Intervention group will also keep
 a sleep diary. At the end of the intervention, the investigators will interview 10
 individuals to learn more about their experiences during the study.
 
 Participants in the Waitlist Control Group will receive the same intervention after the end
 of the study. This group acts as a control for the Intervention group.

ICD-10 Classifications