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

NCT06211075 | Completed

• 1 other identifier: P-PF-12.23.0001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Insomnia

Keywords

CBT-I; Motivational Interviewing; Insomnia; CBT for Insomnia; Mild Insomnia; Moderate Insomnia; CBT for Mild Insomnia; CBT for Moderate Insomnia; CBT for Mild/Moderate Insomnia; CBT-I for Mild Insomnia; CBT-I for Insomnia; CBT-I for Moderate Insomnia; Motivational Interviewing for Moderate Insomnia; Motivational Interviewing for Mild Insomnia; Motivational Interviewing for Insomnia; Feasibility of CBT-I; CBT-I pilot

Outcome Measures

Primary Outcomes (6)

• Enrollment rate

  Number of people enrolled out of the number of people contacted. The higher percentage is the desirable outcome.

  From the beginning of recruitment until the first week of intervention.

• Eligibility rate

  Number of people eligible out of the number of people enrolled. The higher percentage is the desired outcome.

  From the beginning of recruitment until the first week of intervention.

• Attrition

  Number of individuals who dropped out (dropouts only). The study aims to achieve lower attrition rates.

  From enrolment to post-intervention interview (5 weeks in total)

• Change in Insomnia Severity Index (ISI)

  The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score. Total score categories are: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe). The questionnaire demonstrates positive test-retest reliability, internal consistency, and validity. Additionally, it is offered in three versions tailored for different perspectives: patient, clinician, and significant others (spouse). (Bastien et al., 2001; Morin et al., 2011)The lower scores signify milder insomnia. The study aims to achieve lowering in scores (baseline to post-intervention)

  From enrolment to post-intervention interview (5 weeks in total)

• Change in Sleep Condition Indicator (SCI)

  The questionnaire employs an eight-item rating scale, generating a severity score ranging from 0 to 32, where a higher score corresponds to better sleep. A score of 16 or lower suggests probable insomnia. Notably, the questionnaire demonstrates commendable internal consistency and concurrent validity, as evidenced by correlations with the PSQI and ISI. Its effectiveness extends to the measurement of daytime functioning. Furthermore, the questionnaire is accessible in various languages, attesting to its robust linguistic validation (Espie, et al., 2014; Wong et al, 2017). The lower scores signify milder insomnia. The study aims to achieve lowering in scores (baseline to post-intervention)

  From enrolment to post-intervention interview (5 weeks in total)

• Adherence

  Number of sleep diary entries and CBT-I sessions attended. The higher number is the desired outcome.

  From enrolment to post-intervention interview (5 weeks in total)

Secondary Outcomes (6)

• Change in waketime self-reported by participants in their sleep diaries.

  From enrolment to post-intervention interview (5 weeks in total)

• Change in Sleep Onset Latency (SOL) self-reported by participants in their sleep diaries.

  From enrolment to post-intervention interview (5 weeks in total)

• Change in Wake After Sleep Onset (WASO) self-reported by participants in their sleep diaries.

  From enrolment to post-intervention interview (5 weeks in total)

• Change in 'perceived sleep quality' self-reported by participants in their sleep diaries.

  From enrolment to post-intervention interview (5 weeks in total)

• Change in bedtime self-reported by participants in their sleep diaries

  From enrolment to post-intervention interview (5 weeks in total)

Other Outcomes (3)

• Satisfaction with the intervention

  Post-intervention (Week 5)

• Perceived progress

  Post-intervention (Week 5)

• Perceived adherence to the intervention

  Post-intervention (Week 5)

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention will be delivered remotely via zoom or google meets, guided by Overcome coaches. Coaches are trained over two days via training slides, role plays and feedback. The intervention includes CBT-I and Motivational Interviewing.

Behavioral: Cognitive Behavioural Therapy for Insomnia with Motivational Interviewing

Waitlist Control Group (WLC/WLCG)

NO INTERVENTION

Participants will receive the same benefits from the intervention after the end of the main study or after the last participant in the experimental group is interviewed at the post-intervention interview.

Interventions

Cognitive Behavioural Therapy for Insomnia with Motivational Interviewing BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-64
• PHQ-9 score 0-12 indicates no depression, mild or moderate depression
• GAD-7 score 0-12 indicates no anxiety, mild or moderate anxiety symptoms
• Individuals with self-reported difficulties initiating or maintaining sleep which are aligned with the DSM-5 insomnia criteria.
• Access to a computer or mobile with internet connectivity
• Ability to understand and speak English.
• Willingness and ability to participate in the internet-based CBT-I programme for five weeks (including the study-related assessments and post-follow-up interview)
• Willing to provide informed consent.

You may not qualify if:

• Individuals with a history of severe or chronic insomnia
• Those with a history of major psychiatric or neurological disorders (dementia, Alzheimer's disease)
• Those with cognitive impairments
• Those currently receiving or received CBT-I within the past year
• Those currently receiving medication for insomnia
• Individuals with known sleep disorders other than mild-moderate insomnia (sleep apnoea).
• Individuals suffering from chronic pain
• Pregnant and breastfeeding women.
• Not able to understand and respond in the study language.

Sponsors & Collaborators

• Overcome: lead

Study Sites (1)

Overcome

Arnside, LA5 0DP, United Kingdom

Location

Related Publications (23)

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  BACKGROUND

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy; Motivational Interviewing

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Clinical Researcher

Model Details: Group A (Experimental group, Intervention Group): will receive the intervention straight away Group B: (Control, Wait List Control Group): participants are allocated to the waitlist and will receive the intervention after the end of the study.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: January 18, 2024
• Study Start: February 24, 2024
• Primary Completion: November 27, 2024
• Study Completion: March 20, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)