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NCT06211075Recruiting

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

Lay-guided Remotely Delivered Motivational Interviewing and Cognitive-behavioural Therapy for Insomnia: Protocol for a Feasibility and Pilot Study
OvercomeClinicalTrials.govbehavioral
Study focus
Disease/Condition
Insomnia
Drug/Device/Intervention
Cognitive Behavioural Therapy for Insomnia with Motivational Interviewing
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Overcome
Location
Arnside, United Kingdom
Timeline & enrollment
Phase
N/A
Start date
Feb 24, 2024
End date
Apr 08, 2024
Enrollment
50 participants
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
Nonorganic insomniaDisorders of initiating and maintaining sleep [insomnias]Sleep disordersSleep disorder, unspecifiedOther sleep disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06211075
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06211075 through Pure Global AI's free database. This phase not specified trial is sponsored by Overcome and is currently Recruiting. The study focuses on Insomnia. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.