Clinical trial NCT06211075: Cracking the Code to Better Sleep: A Pioneering Study on Remote Support for Insomnia Relief
Official title: Lay-guided Remotely Delivered Motivational Interviewing and Cognitive-behavioural Therapy for Insomnia: Protocol for a Feasibility and Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Overcome
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: The study discusses the prevalence and impact of insomnia, a sleep disorder affecting a significant portion of the population. Insomnia is linked to various health issues, including hypertension, obesity, depression, and reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is recommended as an effective intervention, targeting maladaptive thoughts and behaviors related to sleep. Traditional CBT-I is delivered in a structured manner by licensed clinicians, but there are limitations to its accessibility and long-term efficacy. Internet-based CBT-I is proposed as a more accessible and convenient alternative, potentially overcoming the obstacles associated with traditional delivery methods. The intervention described in the text adopts a digital format, delivering CBT-I remotely with the inclusion of motivational interview techniques to enhance engagement and self-efficacy. Motivational Interviewing (MI) techniques aim to build motivation, rapport, and treatment adherence. MI has been successfully integrated into various treatment interventions, including addiction, psychotherapy, and suicide counselling. The text highlights the research gap in exploring the efficacy and feasibility of internet-based CBT-I, particularly for individuals with mild to moderate insomnia without comorbid disorders. Additionally, there is a lack of research on lay counselling in internet-based CBT-I. Investigating these areas can expand the accessibility and effectiveness of internet-based CBT-I for individuals suffering from insomnia.

This study aims to evaluate the effectiveness and feasibility of remotely delivered cognitive-behavioral therapy for insomnia (CBT-I) combined with motivational interviewing for individuals with mild-moderate insomnia. The efficacy of the treatment will be measured by changes in sleep efficiency, sleep onset latency (SOL), and wake after sleep onset (WASO) using sleep diaries, as well as improvements in sleep quality and insomnia symptoms measured by the Insomnia Severity Index (ISI) and Sleep Condition Indicator (SCI). The feasibility aspect of the study will explore participants\&#39; experiences and perceptions before and after the treatment, determine dropout rates and reasons for dropouts, and examine the frequency of incomplete sleep diary entries and the underlying reasons. The research questions to be answered include whether internet-based CBT-I can effectively improve sleep quality and reduce insomnia symptoms, improve sleep efficiency, SOL, and WASO, and whether remote CBT-I is feasible in terms of participant dropout rates and financial feasibility compared to traditional CBT-I interventions.

The British Association of Psychopharmacology (BAP) has updated guidelines for the treatment of insomnia in different settings, focusing on insomnia without comorbidity, or with mild depressive or anxiety symptoms. This paper aims to provide support for mild-moderate insomnia disorders. Comorbid insomnia and chronic insomnia disorders are better treated with a combination of cognitive behavioral therapy for insomnia (CBT-I) and pharmacological treatments. The inclusion criteria for the study include adults aged 18-64 with mild or no depression and mild anxiety symptoms, as measured by the PHQ-9 and GAD-7 questionnaires. Participants should also have self-reported difficulties initiating or maintaining sleep that align with the DSM-5 insomnia criteria. Exclusion criteria include severe or chronic insomnia, major psychiatric or neurological disorders, cognitive impairments, and current use of CBT-I or medication for insomnia. The initial screening process involves online self-report questionnaires (PHQ-9 \&amp; GAD-7) to identify potential participants. The PHQ-9 is used to assess depression symptoms, while the GAD-7 is used to screen for anxiety disorders. A score of 10 or higher on the PHQ-9 indicates probable depression, and a score of 8 or higher on the GAD-7 indicates probable anxiety disorder. The study will be conducted online, and participants will be recruited through the non-profit organization Overcome in the United Kingdom. Recruitment will involve advertisements on the Overcome website and social media, and interested individuals will complete the initial screening questionnaires via email. Eligible participants will be allocated either to the Intervention Group or Waitlist Control Group. The Intervention Group will receive information about their CBT-I coach and access to a sleep diary.

The study will focus on individuals with mild to moderate insomnia symptoms, as measured by the Insomnia Severity Index (ISI) score. Participants should not exhibit significant signs of clinical depression or anxiety. The CBT-I intervention will be delivered remotely via video conferencing, guided by trained coaches. The study will be conducted online, including participant recruitment, screening, informed consent, assessments, and group allocation. Outcome measures will be assessed online at baseline and one week after the intervention. A subset of participants will be invited to participate in qualitative process evaluation interviews. Participants will be recruited through an online registration process, and randomisation will be conducted to ensure a balanced distribution. The intervention will be delivered by a team of trained coaches, supervised by an experienced coach specialising in CBT-I. Data collection will occur at baseline and post-intervention.

The text discusses the analysis plan for a pilot study, focusing on descriptive analysis rather than hypothesis testing due to the absence of formal power calculations. The goal is to provide a detailed account of the collected data. The plan includes assessing data saturation, member checking, and triangulation to enhance the qualitative findings. The research team will maintain comprehensive records of screening, enrollment, completion of measures, and participation in sessions. Feasibility outcomes will be analysed using frequencies, proportions, means, and standard deviations. Feedback will be thematically analysed through audio-recorded interviews. For efficacy analysis, data will be exported to a software, where statistical analysis will be performed.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Enrollment rate
timeFrame: From the beginning of recruitment until the first week of intervention.
measure: Eligibility rate
timeFrame: From the beginning of recruitment until the first week of intervention.
measure: Attrition
timeFrame: From enrolment to post-intervention interview (5 weeks in total)
measure: Change in Insomnia Severity Index (ISI)
timeFrame: From enrolment to post-intervention interview (5 weeks in total)
measure: Change in Sleep Condition Indicator (SCI)
timeFrame: From enrolment to post-intervention interview (5 weeks in total)
measure: Adherence
timeFrame: From enrolment to post-intervention interview (5 weeks in total)
Secondary outcomes:
measure: Change in waketime self-reported by participants in their sleep diaries.
timeFrame: From enrolment to post-intervention interview (5 weeks in total)
measure: Change in Sleep Onset Latency (SOL) self-reported by participants in their sleep diaries.
timeFrame: From enrolment to post-intervention interview (5 weeks in total)
measure: Change in Wake After Sleep Onset (WASO) self-reported by participants in their sleep diaries.
timeFrame: From enrolment to post-intervention interview (5 weeks in total)
measure: Change in 'perceived sleep quality' self-reported by participants in their sleep diaries.
timeFrame: From enrolment to post-intervention interview (5 weeks in total)
measure: Change in bedtime self-reported by participants in their sleep diaries
timeFrame: From enrolment to post-intervention interview (5 weeks in total)
measure: Change in number of naps from baseline to post-intervention.
timeFrame: From enrolment to post-intervention interview (5 weeks in total)
Other outcomes:
measure: Satisfaction with the intervention
timeFrame: Post-intervention (Week 5)
measure: Perceived progress
timeFrame: Post-intervention (Week 5)
measure: Perceived adherence to the intervention
timeFrame: Post-intervention (Week 5)
Locations:
city: Arnside
country: United Kingdom
facility: Overcome
Study officials:
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