InsomniaNCT06211075
Cracking the Code to Better Sleep: A Pioneering Study on Remote Support for Insomnia Relief
A study testing Cognitive Behavioural Therapy for Insomnia with Motivational Interviewing in people with Insomnia, run by Overcome at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Behavioural Therapy for Insomnia with Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2024to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- Individuals suffering from chronic pain
- Pregnant and breastfeeding women.
- Not able to understand and respond in the study language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lay-guided Remotely Delivered Motivational Interviewing and Cognitive-behavioural Therapy for Insomnia: Protocol for a Feasibility and Pilot Study
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?
Read more
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.
Read the 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\' 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 \& 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.
- Conditions
- Insomnia
- Being tested
- Cognitive Behavioural Therapy for Insomnia with Motivational Interviewing
- 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
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy for Insomnia with Motivational InterviewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Number of people enrolled out of the number of people contacted. The higher percentage is the desirable outcome.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: From enrolment to post-intervention interview (5 weeks in total)
Secondary outcomes (6)
Change in waketime self-reported by participants in their sleep diaries.
Participants will record their waketime every day for four weeks in their sleep diaries. The researchers will analyse the progression of the waketime over 4 weeks.
Measured: From enrolment to post-intervention interview (5 weeks in total)
Change in Sleep Onset Latency (SOL) self-reported by participants in their sleep diaries.
Participants will record the duration of time from turning the light off to falling asleep in their sleep diaries over the course of intervention. The researchers will analyse the progression of SOL over 4 weeks. The lower the SOL, the better the outcomes are.
Measured: 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.
Participants will record their total number of minutes that a person is awake after having initially fallen asleep in their sleep diaries over the course of 4 weeks. The researchers will analyse the progression of SOL over 4 weeks. The lower the WASO, the better the outcomes are.
Measured: From enrolment to post-intervention interview (5 weeks in total)
Change in 'perceived sleep quality' self-reported by participants in their sleep diaries.
Participants will report their perceived sleep quality every day in their sleep diaries. The will rate their sleep on the scale from 1 to 10. The researchers will analyse the progression of the scores over the course of 4 weeks and compare the scares from baseline assessment and post-intervention. The positive difference is the desired outcome.
Measured: From enrolment to post-intervention interview (5 weeks in total)
Change in bedtime self-reported by participants in their sleep diaries
Participants will record their bedtime every day for four weeks in their sleep diaries. The researchers will analyse the progression of the bedtime over 4 weeks.
Measured: From enrolment to post-intervention interview (5 weeks in total)
Change in number of naps from baseline to post-intervention.
Participants will record their number of naps every day for four weeks in their sleep diaries. The intervention aims to reduce the number of naps taken during the day over the course of the intervention.
Measured: From enrolment to post-intervention interview (5 weeks in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start24 Feb 2024
- Primary completion27 Nov 2024
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Overcome
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Ermolenko, Overcome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211075
- Sponsor's protocol ID
- P-PF-12.23.0001
- Status last verified
- Jun 2025
- First submitted
- 29 Nov 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As it is a pilot and feasibility study, the researchers decided to not make the IPDs shareable to other researchers outside of Outcome. The access to trial IPD will be limited to the researchers within Overcome for future full-scale research. However, the researchers might reconsider at the end of the study, if the results from the thematic analysis and/or statistical analysis would be outside of our predictions.
Publications
Yasugaki S, Okamura H, Kaneko A, Hayashi Y. Bidirectional relationship between sleep and depression. Neurosci Res. 2025 Feb;211:57-64. doi: 10.1016/j.neures.2023.04.006. Epub 2023 Apr 26.
PubMed 37116584Wilson SJ, Nutt DJ, Alford C, Argyropoulos SV, Baldwin DS, Bateson AN, Britton TC, Crowe C, Dijk DJ, Espie CA, Gringras P, Hajak G, Idzikowski C, Krystal AD, Nash JR, Selsick H, Sharpley AL, Wade AG. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol. 2010 Nov;24(11):1577-601. doi: 10.1177/0269881110379307. Epub 2010 Sep 2.
PubMed 20813762Theppornpitak W, Hemrungrojn S, Thienwiwatnukul K, Muntham D, Chirakalwasan N, Srisawart P. Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. Front Neurol. 2023 Jun 2;14:1180339. doi: 10.3389/fneur.2023.1180339. eCollection 2023.
PubMed 37346166Siengsukon CF, Alshehri M, Williams C, Drerup M, Lynch S. Feasibility and treatment effect of cognitive behavioral therapy for insomnia in individuals with multiple sclerosis: A pilot randomized controlled trial. Mult Scler Relat Disord. 2020 May;40:101958. doi: 10.1016/j.msard.2020.101958. Epub 2020 Jan 23.
PubMed 32014809Salwen-Deremer JK, Smith MT, Aschbrenner KA, Haskell HG, Speed BC, Siegel CA. A pilot feasibility trial of cognitive-behavioural therapy for insomnia in people with inflammatory bowel disease. BMJ Open Gastroenterol. 2021 Dec;8(1):e000805. doi: 10.1136/bmjgast-2021-000805.
PubMed 34969664Retzer L, Feil M, Reindl R, Richter K, Lehmann R, Stemmler M, Graessel E. Anonymous online cognitive behavioral therapy for sleep disorders in shift workers-a study protocol for a randomized controlled trial. Trials. 2021 Aug 16;22(1):539. doi: 10.1186/s13063-021-05437-9.
PubMed 34399824Pollak KI, Childers JW, Arnold RM. Applying motivational interviewing techniques to palliative care communication. J Palliat Med. 2011 May;14(5):587-92. doi: 10.1089/jpm.2010.0495. Epub 2011 Feb 3.
PubMed 21291329Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016 Mar-Apr;39:24-31. doi: 10.1016/j.genhosppsych.2015.11.005. Epub 2015 Nov 18.
PubMed 26719105Matthews EE, Arnedt JT, McCarthy MS, Cuddihy LJ, Aloia MS. Adherence to cognitive behavioral therapy for insomnia: a systematic review. Sleep Med Rev. 2013 Dec;17(6):453-64. doi: 10.1016/j.smrv.2013.01.001. Epub 2013 Apr 17.
PubMed 23602124Karlin BE, Trockel M, Spira AP, Taylor CB, Manber R. National evaluation of the effectiveness of cognitive behavioral therapy for insomnia among older versus younger veterans. Int J Geriatr Psychiatry. 2015 Mar;30(3):308-15. doi: 10.1002/gps.4143. Epub 2014 May 29.
PubMed 24890708Johnson JA, Rash JA, Campbell TS, Savard J, Gehrman PR, Perlis M, Carlson LE, Garland SN. A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors. Sleep Med Rev. 2016 Jun;27:20-8. doi: 10.1016/j.smrv.2015.07.001. Epub 2015 Aug 1.
PubMed 26434673Grupp-Phelan J, Stevens J, Boyd S, Cohen DM, Ammerman RT, Liddy-Hicks S, Heck K, Marcus SC, Stone L, Campo JV, Bridge JA. Effect of a Motivational Interviewing-Based Intervention on Initiation of Mental Health Treatment and Mental Health After an Emergency Department Visit Among Suicidal Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1917941. doi: 10.1001/jamanetworkopen.2019.17941.
PubMed 31860104Glass J, Lanctot KL, Herrmann N, Sproule BA, Busto UE. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ. 2005 Nov 19;331(7526):1169. doi: 10.1136/bmj.38623.768588.47. Epub 2005 Nov 11.
PubMed 16284208Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872.
PubMed 22654196Edinger JD, Bonnet MH, Bootzin RR, Doghramji K, Dorsey CM, Espie CA, Jamieson AO, McCall WV, Morin CM, Stepanski EJ; American Academy of Sleep Medicine Work Group. Derivation of research diagnostic criteria for insomnia: report of an American Academy of Sleep Medicine Work Group. Sleep. 2004 Dec 15;27(8):1567-96. doi: 10.1093/sleep/27.8.1567.
PubMed 15683149
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lay-guided Remotely Delivered Motivational Interviewing and Cognitive-behavioural Therapy for Insomnia: Protocol for a Feasibility and Pilot Study
- ClinicalTrials.gov ID
- NCT06211075
- Acronym / sponsor ID
- P-PF-12.23.0001
- Conditions
- Insomnia
- Keywords
- CBT-I, Motivational Interviewing, Insomnia, CBT for Insomnia, Mild Insomnia, Moderate Insomnia, CBT for Mild Insomnia, CBT for Moderate Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- OvercomeUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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\' 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 \& 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Cognitive Behavioural Therapy for Insomnia with Motivational InterviewingThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy for Insomnia with Motivational InterviewingThis 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. | Behavioural | Intervention Group |
Primary outcome
Enrollment rate
Time frame: From the beginning of recruitment until the first week of intervention.
Number of people enrolled out of the number of people contacted. The higher percentage is the desirable outcome.
Eligibility rate
Time frame: From the beginning of recruitment until the first week of intervention.
Number of people eligible out of the number of people enrolled. The higher percentage is the desired outcome.
Attrition
Time frame: From enrolment to post-intervention interview (5 weeks in total)
Number of individuals who dropped out (dropouts only). The study aims to achieve lower attrition rates.
Change in Insomnia Severity Index (ISI)
Time frame: From enrolment to post-intervention interview (5 weeks in total)
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)
Change in Sleep Condition Indicator (SCI)
Time frame: From enrolment to post-intervention interview (5 weeks in total)
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)
Adherence
Time frame: From enrolment to post-intervention interview (5 weeks in total)
Number of sleep diary entries and CBT-I sessions attended. The higher number is the desired outcome.
6 secondary outcomes
Change in waketime self-reported by participants in their sleep diaries.
Time frame: From enrolment to post-intervention interview (5 weeks in total)
Change in Sleep Onset Latency (SOL) self-reported by participants in their sleep diaries.
Time frame: 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.
Time frame: From enrolment to post-intervention interview (5 weeks in total)
Change in 'perceived sleep quality' self-reported by participants in their sleep diaries.
Time frame: From enrolment to post-intervention interview (5 weeks in total)
Change in bedtime self-reported by participants in their sleep diaries
Time frame: From enrolment to post-intervention interview (5 weeks in total)
Change in number of naps from baseline to post-intervention.
Time frame: From enrolment to post-intervention interview (5 weeks in total)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Background: PubMed 37116584Yasugaki S, Okamura H, Kaneko A, Hayashi Y. Bidirectional relationship between sleep and depression. Neurosci Res. 2025 Feb;211:57-64. doi: 10.1016/j.neures.2023.04.006. Epub 2023 Apr 26.
- Background: PubMed 20813762Wilson SJ, Nutt DJ, Alford C, Argyropoulos SV, Baldwin DS, Bateson AN, Britton TC, Crowe C, Dijk DJ, Espie CA, Gringras P, Hajak G, Idzikowski C, Krystal AD, Nash JR, Selsick H, Sharpley AL, Wade AG. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol. 2010 Nov;24(11):1577-601. doi: 10.1177/0269881110379307. Epub 2010 Sep 2.
- Background: PubMed 37346166Theppornpitak W, Hemrungrojn S, Thienwiwatnukul K, Muntham D, Chirakalwasan N, Srisawart P. Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. Front Neurol. 2023 Jun 2;14:1180339. doi: 10.3389/fneur.2023.1180339. eCollection 2023.
- Background: PubMed 32014809Siengsukon CF, Alshehri M, Williams C, Drerup M, Lynch S. Feasibility and treatment effect of cognitive behavioral therapy for insomnia in individuals with multiple sclerosis: A pilot randomized controlled trial. Mult Scler Relat Disord. 2020 May;40:101958. doi: 10.1016/j.msard.2020.101958. Epub 2020 Jan 23.
- Background: PubMed 34969664Salwen-Deremer JK, Smith MT, Aschbrenner KA, Haskell HG, Speed BC, Siegel CA. A pilot feasibility trial of cognitive-behavioural therapy for insomnia in people with inflammatory bowel disease. BMJ Open Gastroenterol. 2021 Dec;8(1):e000805. doi: 10.1136/bmjgast-2021-000805.
- Background: PubMed 34399824Retzer L, Feil M, Reindl R, Richter K, Lehmann R, Stemmler M, Graessel E. Anonymous online cognitive behavioral therapy for sleep disorders in shift workers-a study protocol for a randomized controlled trial. Trials. 2021 Aug 16;22(1):539. doi: 10.1186/s13063-021-05437-9.
- Background: PubMed 21291329Pollak KI, Childers JW, Arnold RM. Applying motivational interviewing techniques to palliative care communication. J Palliat Med. 2011 May;14(5):587-92. doi: 10.1089/jpm.2010.0495. Epub 2011 Feb 3.
- Background: PubMed 26719105Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016 Mar-Apr;39:24-31. doi: 10.1016/j.genhosppsych.2015.11.005. Epub 2015 Nov 18.
- Background: PubMed 23602124Matthews EE, Arnedt JT, McCarthy MS, Cuddihy LJ, Aloia MS. Adherence to cognitive behavioral therapy for insomnia: a systematic review. Sleep Med Rev. 2013 Dec;17(6):453-64. doi: 10.1016/j.smrv.2013.01.001. Epub 2013 Apr 17.
- Background: PubMed 24890708Karlin BE, Trockel M, Spira AP, Taylor CB, Manber R. National evaluation of the effectiveness of cognitive behavioral therapy for insomnia among older versus younger veterans. Int J Geriatr Psychiatry. 2015 Mar;30(3):308-15. doi: 10.1002/gps.4143. Epub 2014 May 29.
- Background: PubMed 26434673Johnson JA, Rash JA, Campbell TS, Savard J, Gehrman PR, Perlis M, Carlson LE, Garland SN. A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors. Sleep Med Rev. 2016 Jun;27:20-8. doi: 10.1016/j.smrv.2015.07.001. Epub 2015 Aug 1.
- Background: PubMed 31860104Grupp-Phelan J, Stevens J, Boyd S, Cohen DM, Ammerman RT, Liddy-Hicks S, Heck K, Marcus SC, Stone L, Campo JV, Bridge JA. Effect of a Motivational Interviewing-Based Intervention on Initiation of Mental Health Treatment and Mental Health After an Emergency Department Visit Among Suicidal Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1917941. doi: 10.1001/jamanetworkopen.2019.17941.
- Individual participant dataSharing planned: No. As it is a pilot and feasibility study, the researchers decided to not make the IPDs shareable to other researchers outside of Outcome. The access to trial IPD will be limited to the researchers within Overcome for future full-scale research. However, the researchers might reconsider at the end of the study, if the results from the thematic analysis and/or statistical analysis would be outside of our predictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy for Insomnia with Motivational Interviewing in people with Insomnia, run by Overcome at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: From the beginning of recruitment until the first week of intervention.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06211075, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.