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

NCT06211075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-02

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Cognitive Behavioural Therapy for Insomnia with Motivational Interviewing

This intervention implements elements of Cognitive Behavioural Therapy for Insomnia with motivational interview techniques incorporated into the intervention, aiming to build long-lasting motivation, better rapport with the patients and self-efficacy to increase engagement rate despite its remotely delivered format. The whole intervention is delivered online.

Sponsors & Collaborators

  • Overcome

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-24
Primary Completion
2024-11-27
Completion
2025-03-20

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06211075 on ClinicalTrials.gov