Sleep ProblemSTOP-PilotNCT03062891
Sleep Treatment Outcome Predictors: A Pilot Study (STOP-pilot)
A study testing Online CBT for insomnia in people with Sleep Problem, run by King's College London at 3 sites in United Kingdom.
Trial summary
Insomnia occurs frequently causing a substantial burden to society (1). Historically, insomnia has been considered as secondary to a handful of other psychiatric disorders, such as depression and anxiety - but it is now clear that this disorder is associated with a wide range of psychiatric conditions and may actually… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Problem
- What is being tested?
- Online CBT for insomnia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Nov 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Aged 18 plus
- Psychology student (undergraduate or postgraduate) at one of three London universities involved in the study.
Who cannot join
- Male
- Under 18
- Not a psychology student (undergraduate or postgraduate) at one of three London universities involved in the study.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Queen Mary, University of London
London, E1 4NS
Goldsmiths, University of London
London, SE14 6NW
King's College London
London, WC2R 2LS
About this study
Insomnia occurs frequently causing a substantial burden to society (1). Historically, insomnia has been considered as secondary to a handful of other psychiatric disorders, such as depression and anxiety - but it is now clear that this disorder is associated with a wide range of psychiatric conditions and may actually precede and predict their development and severity (e.g. 2). Treating insomnia has been posited to hold the promise of reducing or preventing the development of co-morbid problems - although this possibility needs to be rigorously tested.
Cognitive behavioural therapy (CBT) is an effective treatment for disturbed sleep, specifically insomnia, in adults (3) and is recommended by NICE for the management of long-term sleep problems. This treatment is more accessible than ever before given recent ground-breaking internet initiatives - such as the Sleepio programme (see: https://www.sleepio.com/home/), which was developed by one of the collaborators (Colin Espie) and has yielded encouraging results (4).
Read more
Despite the importance of CBT for treating disturbed sleep and the finding that it leads to a good outcome for the majority of sufferers, some people fail to respond to this treatment. For example, research cited on the Sleepio website notes that around 70% of those with even very long term sleep difficulties experience long-term improvements from the treatment, meaning that 30% do not (see 4). Understanding more about who does and does not respond holds the promise of improving or tailoring treatments for insomnia.
The study proposed here builds on recent work by one of the researchers who has been exploring demographic (5), clinical (e.g. 6) and most uniquely genetic (e.g. 7); and epigenetic (e.g. 8) predictors of psychological treatment response (coining the term Therapygenetics, see, 7). While these predictors are individually only likely to explain a small proportion of the variance of treatment outcome, understanding these multiple risks and their interaction is the best way to consider this issue. The study addressed here is a pilot study, necessary to demonstrate feasibility of utilising a sleep intervention application in an unselected sample of young adults, prior to applying for grant funding to undertake a larger but similar behavioural genetics study in the future.
The main aim of this pilot study is to test the feasibility of the study design, by investigating whether unselected participants show an improvement in sleep quality after taking the intervention. Participation and drop out rates as well acceptability of the intervention in a non-clinical population will also be investigated.
Research Questions:
- Does the online CBT intervention improve sleep quality in a non-clinical, unselected sample?
- How feasible is it to run this study on a non-clinical sample? This will include investigating response rate, participant drop-out, and treatment accessibility. The investigators will also offer perform preliminary investigations into:
- Does improving sleep quality have implications for associated phenotypes? Specifically the investigators will examine symptoms of anxiety, depression, attention-deficit hyperactivity disorder (ADHD), psychosis, and well-being.
- Which demographic, clinical, genetic, and epigenetic factors predict treatment outcome for sleep problems?
Research questions 3) and 4) will be primary aims in the main study, but will constitute secondary aims in the pilot study as there won't be the statistical power to fully address these questions.
- Conditions
- Sleep Problem
- Being tested
- Online CBT for insomnia
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online CBT for insomniaProcedure or surgery
See CBT arm description for information about the CBT intervention. More details can be found in source 4 in the reference list.
| Study group | Role | What they receive |
|---|---|---|
| Online CBT for insomnia | Experimental | CBT participants will receive six weekly sessions delivered by an animated 'virtual therapist' (The Prof) via the online platform 'Sleepio'. The programme comprises a fully automated media-rich web application, driven dynamically by baseline, adherence, performance and progress data, and provides additional access to elements such as an online library with background information, a community of fellow users, and support, prompts and reminders sent by e-mail.
CBT content was consistent with the literature (4) and covered behavioral (e.g., sleep restriction, stimulus control) and cognitive (e.g., putting the day to rest, thought restructuring, imagery, articulatory suppression, paradoxical intention, mindfulness) strategies, as well as additional relaxation strategies (progressive muscle relaxation and autogenic training) and advice on lifestyle and bedroom factors (sleep hygiene). The intervention was based upon a previously validated manual (4). Receives: Procedure: Online CBT for insomnia |
| Puzzles | No intervention | Each week participants will be sent a puzzle to complete online (e.g. logic puzzles, crosswords etc). The puzzles have been designed to be cognitively engaging and take a similar amount of time to one session of Sleepio (20-25 minutes). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Insomnia Symptoms Following Online CBT
Changes in insomnia symptoms as assessed by scores on the Sleep Condition Indicator (SCI). This pilot aims to establish the distributional properties of individual differences in change score on this measure. The scale has a theoretical range of 0-32. A higher score indicates fewer insomnia symptoms. Therefore a positive change score (>0) indicates fewer insomnia symptoms at the end of the intervention compared to baseline. A negative score (<0) indicates more symptoms at the end of the itnervention compared to baseline.
Measured: Change from baseline to 3 weeks, 6 weeks, and 6 months
Improvement in Sleep Quality Following Online CBT
Changes in sleep quality as assessed by scores on the Pittsburgh Sleep Quality Index (PSQI). This pilot aims to establish the distributional properties of individual differences in change score on this measure. The scale has a theoretical range of 0-21. The change score reflects the change in symptoms at each assessment compared with baseline. Higher scores on the indicate worse sleep quality. Therefore for the change score, a positive value indicates worse sleep quality at the assessment time period compared to baseline. A negative value indicates better sleep quality at the assessment time period compared to baseline.
Measured: Change from baseline to 3 weeks, 6 weeks, and 6 months
Treatment Acceptability Mid-intervention
Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability.
Measured: 3 weeks
Treatment Acceptability at the End of the Intervention
Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability.
Measured: 6 weeks
Change in Treatment Acceptability During the Intervention
Change in treatment acceptability across the CBT-I treatment will be assessed, through changes in the score on the Treatment Acceptability Scale. Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability. Therefore a positive change score means an improvement in treatment acceptability, whereas a negative change score indicates a reduction in treatment acceptability.
Measured: Change from baseline to 3 weeks and 6 weeks
Attrition Rate
Drop-out rate will be assessed as the percentage of those who consented to take part in the study who did not complete the study.
Measured: 6 months
Secondary outcomes (13)
Predictors of Treatment Outcome - Anxiety
Anxiety as a predictor of response to treatment outcome, as measured using the Trait State Anxiety Index. The theoretical range is 20-80, and a higher score indicates more anxiety symptoms at baseline
Measured: Baseline
Predictors of Treatment Outcome - Depression
Anxiety as a predictor of response to treatment outcome, as measured using the Mood and Feelings Questionnaire. The theoretical range is 0-26, and a higher score indicates more anxiety symptoms at baseline
Measured: Baseline
Predictors of Treatment Outcome - Attentional Problems
Attentional problems as a predictor of response to treatment outcome, as measured using the ADHD symptoms questionnaire. The theoretical range is 1-54, and a higher score indicates more attentional problems at baseline
Measured: Baseline
Predictors of Treatment Outcome - Psychotic Experiences
Psychotic experiences as a predictor of response to treatment outcome, as measured using the Specific Psychotic Experiences Questionnaire. Subsacles measuring paranoia (theoretical range 0-25), hallucinations (theoretical range 0-25), and cognitive disorganization (0-5) were used. On all subscales, a higher score indicates more psychotic experiences at baseline
Measured: Baseline
Predictors of Treatment Outcome - Positive Mental Health
Positive mental health as a predictor of response to treatment outcome, as measured using the Positive Mental Health Scale. The theoretical range is 1-36, and a higher score indicates higher levels of positive mental health at baseline
Measured: Baseline
Predictors of Treatment Outcome - Stress
Stress as a predictor of response to treatment outcome, as measured using the Perceived Stress Scale. The theoretical range is 5-50, and a higher score indicates more perceived stress at baseline
Measured: Baseline
Predictors of Treatment Outcome - Threatening Life Events
Threatening life events as a predictor of response to treatment outcome, as measured using the List of Threatening Events. The theoretical range is 0-24, and a higher score indicates more exposure to threatening events in the 12 months preceeding baseline
Measured: Baseline
Changes in Scores on Associated Phenotypes - Anxiety
Anxiety symptoms, measured using the State Trait Anxiety Index. The theoretical range is 20-80, and a higher score indicates more anxiety symptoms at baseline.
Measured: 3 weeks, 6 weeks
Changes in Scores on Associated Phenotypes - Depression
Depression symptoms, as measured using the Trait State Anxiety Index. The theoretical range is 0-26, and a higher score indicates more depression symptoms.
Measured: 3 weeks, 6 weeks
Changes in Scores on Associated Phenotypes - Attentional Problems
Attentional problems, as measured using the ADHD symptoms questionnaire. The theoretical range is 1-54, and a higher score indicates more attentional problems.
Measured: 3 weeks, 6 weeks
Changes in Scores on Associated Phenotypes - Psychotic Experiences
Psychotic experiences, as measured using the Specific Psychotic Experiences Questionnaire. Three subscales measuring paranoia (theoretical ragne 0-25), hallucinations (0-25), and cognitive disorganization (0-5) were used. On all subscales, a higher score equals more frequent experiences
Measured: 6 weeks
Changes in Scores on Associated Phenotypes - Positive Mental Health
Positive mental health, as measured using the Positive Mental Health Scale. The theoretical range is 1-36, and a higher score indicates higher levels of positive mental health.
Measured: 3 weeks, 6 weeks
Changes in Scores on Associated Phenotypes - Stress
Perceived stress, as measured using the Perceived Stress Scale. The theoretical range is 5-50, and a higher score indicates higher levels of perceived stress.
Measured: 3 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study startNov 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Sleep ProblemStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Goldsmiths, University of London, Queen Mary University of London, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Alice M Gregory, PhD, Principal investigator, Goldsmiths, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062891
- Sponsor's protocol ID
- STOP-0001-PILOT
- Acronym
- STOP-Pilot
- Status last verified
- Jan 2017
- First submitted
- 5 Dec 2016
- Last updated
- 16 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kessler RC, Berglund PA, Coulouvrat C, Hajak G, Roth T, Shahly V, Shillington AC, Stephenson JJ, Walsh JK. Insomnia and the performance of US workers: results from the America insomnia survey. Sleep. 2011 Sep 1;34(9):1161-71. doi: 10.5665/SLEEP.1230.
PubMed 21886353Harvey AG. Insomnia: symptom or diagnosis? Clin Psychol Rev. 2001 Oct;21(7):1037-59. doi: 10.1016/s0272-7358(00)00083-0.
PubMed 11584515Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, Lichstein KL. Psychological and behavioral treatment of insomnia:update of the recent evidence (1998-2004). Sleep. 2006 Nov;29(11):1398-414. doi: 10.1093/sleep/29.11.1398.
PubMed 17162986Espie 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 22654196Hudson JL, Lester KJ, Lewis CM, Tropeano M, Creswell C, Collier DA, Cooper P, Lyneham HJ, Morris T, Rapee RM, Roberts S, Donald JA, Eley TC. Predicting outcomes following cognitive behaviour therapy in child anxiety disorders: the influence of genetic, demographic and clinical information. J Child Psychol Psychiatry. 2013 Oct;54(10):1086-94. doi: 10.1111/jcpp.12092. Epub 2013 Jun 18.
PubMed 23772677Hudson JL, Keers R, Roberts S, Coleman JR, Breen G, Arendt K, Bogels S, Cooper P, Creswell C, Hartman C, Heiervang ER, Hotzel K, In-Albon T, Lavallee K, Lyneham HJ, Marin CE, McKinnon A, Meiser-Stedman R, Morris T, Nauta M, Rapee RM, Schneider S, Schneider SC, Silverman WK, Thastum M, Thirlwall K, Waite P, Wergeland GJ, Lester KJ, Eley TC. Clinical Predictors of Response to Cognitive-Behavioral Therapy in Pediatric Anxiety Disorders: The Genes for Treatment (GxT) Study. J Am Acad Child Adolesc Psychiatry. 2015 Jun;54(6):454-63. doi: 10.1016/j.jaac.2015.03.018. Epub 2015 Apr 1.
PubMed 26004660Eley TC, Hudson JL, Creswell C, Tropeano M, Lester KJ, Cooper P, Farmer A, Lewis CM, Lyneham HJ, Rapee RM, Uher R, Zavos HM, Collier DA. Therapygenetics: the 5HTTLPR and response to psychological therapy. Mol Psychiatry. 2012 Mar;17(3):236-7. doi: 10.1038/mp.2011.132. Epub 2011 Oct 25. No abstract available.
PubMed 22024766Roberts S, Lester KJ, Hudson JL, Rapee RM, Creswell C, Cooper PJ, Thirlwall KJ, Coleman JR, Breen G, Wong CC, Eley TC. Serotonin transporter [corrected] methylation and response to cognitive behaviour therapy in children with anxiety disorders. Transl Psychiatry. 2014 Sep 16;4(9):e444. doi: 10.1038/tp.2014.83.
PubMed 25226553Vgontzas AN, Fernandez-Mendoza J, Liao D, Bixler EO. Insomnia with objective short sleep duration: the most biologically severe phenotype of the disorder. Sleep Med Rev. 2013 Aug;17(4):241-54. doi: 10.1016/j.smrv.2012.09.005. Epub 2013 Feb 16.
PubMed 23419741Denis D, Poerio GL, Derveeuw S, Badini I, Gregory AM. Associations between exploding head syndrome and measures of sleep quality and experiences, dissociation, and well-being. Sleep. 2019 Feb 1;42(2). doi: 10.1093/sleep/zsy216.
PubMed 30544141Denis D, Eley TC, Rijsdijk F, Zavos HMS, Keers R, Espie CA, Luik AI, Badini I, Derveeuw S, Romero A, Hodsoll J, Gregory AM. Sleep Treatment Outcome Predictors (STOP) Pilot Study: a protocol for a randomised controlled trial examining predictors of change of insomnia symptoms and associated traits following cognitive-behavioural therapy for insomnia in an unselected sample. BMJ Open. 2017 Dec 1;7(11):e017177. doi: 10.1136/bmjopen-2017-017177.
PubMed 29196479
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Treatment Outcome Predictors: A Pilot Study (STOP-pilot)
- ClinicalTrials.gov ID
- NCT03062891
- Acronym / sponsor ID
- STOP-Pilot / STOP-0001-PILOT
- Conditions
- Sleep Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Goldsmiths, University of London, Queen Mary University of London, University of Oxford
- Study start
- Nov 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Posted 16 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insomnia occurs frequently causing a substantial burden to society (1). Historically, insomnia has been considered as secondary to a handful of other psychiatric disorders, such as depression and anxiety - but it is now clear that this disorder is associated with a wide range of psychiatric conditions and may actually precede and predict their development and severity (e.g. 2). Treating insomnia has been posited to hold the promise of reducing or preventing the development of co-morbid problems - although this possibility needs to be rigorously tested.
Cognitive behavioural therapy (CBT) is an effective treatment for disturbed sleep, specifically insomnia, in adults (3) and is recommended by NICE for the management of long-term sleep problems. This treatment is more accessible than ever before given recent ground-breaking internet initiatives - such as the Sleepio programme (see: https://www.sleepio.com/home/), which was developed by one of the collaborators (Colin Espie) and has yielded encouraging results (4).
Despite the importance of CBT for treating disturbed sleep and the finding that it leads to a good outcome for the majority of sufferers, some people fail to respond to this treatment. For example, research cited on the Sleepio website notes that around 70% of those with even very long term sleep difficulties experience long-term improvements from the treatment, meaning that 30% do not (see 4). Understanding more about who does and does not respond holds the promise of improving or tailoring treatments for insomnia.
The study proposed here builds on recent work by one of the researchers who has been exploring demographic (5), clinical (e.g. 6) and most uniquely genetic (e.g. 7); and epigenetic (e.g. 8) predictors of psychological treatment response (coining the term Therapygenetics, see, 7). While these predictors are individually only likely to explain a small proportion of the variance of treatment outcome, understanding these multiple risks and their interaction is the best way to consider this issue. The study addressed here is a pilot study, necessary to demonstrate feasibility of utilising a sleep intervention application in an unselected sample of young adults, prior to applying for grant funding to undertake a larger but similar behavioural genetics study in the future.
The main aim of this pilot study is to test the feasibility of the study design, by investigating whether unselected participants show an improvement in sleep quality after taking the intervention. Participation and drop out rates as well acceptability of the intervention in a non-clinical population will also be investigated.
Research Questions:
- Does the online CBT intervention improve sleep quality in a non-clinical, unselected sample?
- How feasible is it to run this study on a non-clinical sample? This will include investigating response rate, participant drop-out, and treatment accessibility. The investigators will also offer perform preliminary investigations into:
- Does improving sleep quality have implications for associated phenotypes? Specifically the investigators will examine symptoms of anxiety, depression, attention-deficit hyperactivity disorder (ADHD), psychosis, and well-being.
- Which demographic, clinical, genetic, and epigenetic factors predict treatment outcome for sleep problems?
Research questions 3) and 4) will be primary aims in the main study, but will constitute secondary aims in the pilot study as there won't be the statistical power to fully address these questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online CBT for insomnia | Experimental | Procedure: Online CBT for insomniaCBT participants will receive six weekly sessions delivered by an animated 'virtual therapist' (The Prof) via the online platform 'Sleepio'. The programme comprises a fully automated media-rich web application, driven dynamically by baseline, adherence, performance and progress data, and provides additional access to elements such as an online library with background information, a community of fellow users, and support, prompts and reminders sent by e-mail. CBT content was consistent with the literature (4) and covered behavioral (e.g., sleep restriction, stimulus control) and cognitive (e.g., putting the day to rest, thought restructuring, imagery, articulatory suppression, paradoxical intention, mindfulness) strategies, as well as additional relaxation strategies (progressive muscle relaxation and autogenic training) and advice on lifestyle and bedroom factors (sleep hygiene). The intervention was based upon a previously validated manual (4). |
| Puzzles | No intervention | –Each week participants will be sent a puzzle to complete online (e.g. logic puzzles, crosswords etc). The puzzles have been designed to be cognitively engaging and take a similar amount of time to one session of Sleepio (20-25 minutes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Aged 18 plus
- Psychology student (undergraduate or postgraduate) at one of three London universities involved in the study.
Key exclusion criteria (3 listed)
- Male
- Under 18
- Not a psychology student (undergraduate or postgraduate) at one of three London universities involved in the study.
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 |
|---|---|---|
| Online CBT for insomniaSee CBT arm description for information about the CBT intervention. More details can be found in source 4 in the reference list. | Procedure or surgery | Online CBT for insomnia |
Primary outcome
Improvement in Insomnia Symptoms Following Online CBT
Time frame: Change from baseline to 3 weeks, 6 weeks, and 6 months
Changes in insomnia symptoms as assessed by scores on the Sleep Condition Indicator (SCI). This pilot aims to establish the distributional properties of individual differences in change score on this measure. The scale has a theoretical range of 0-32. A higher score indicates fewer insomnia symptoms. Therefore a positive change score (>0) indicates fewer insomnia symptoms at the end of the intervention compared to baseline. A negative score (<0) indicates more symptoms at the end of the itnervention compared to baseline.
Improvement in Sleep Quality Following Online CBT
Time frame: Change from baseline to 3 weeks, 6 weeks, and 6 months
Changes in sleep quality as assessed by scores on the Pittsburgh Sleep Quality Index (PSQI). This pilot aims to establish the distributional properties of individual differences in change score on this measure. The scale has a theoretical range of 0-21. The change score reflects the change in symptoms at each assessment compared with baseline. Higher scores on the indicate worse sleep quality. Therefore for the change score, a positive value indicates worse sleep quality at the assessment time period compared to baseline. A negative value indicates better sleep quality at the assessment time period compared to baseline.
Treatment Acceptability Mid-intervention
Time frame: 3 weeks
Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability.
Treatment Acceptability at the End of the Intervention
Time frame: 6 weeks
Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability.
Change in Treatment Acceptability During the Intervention
Time frame: Change from baseline to 3 weeks and 6 weeks
Change in treatment acceptability across the CBT-I treatment will be assessed, through changes in the score on the Treatment Acceptability Scale. Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability. Therefore a positive change score means an improvement in treatment acceptability, whereas a negative change score indicates a reduction in treatment acceptability.
Attrition Rate
Time frame: 6 months
Drop-out rate will be assessed as the percentage of those who consented to take part in the study who did not complete the study.
13 secondary outcomes
Predictors of Treatment Outcome - Anxiety
Time frame: Baseline
Predictors of Treatment Outcome - Depression
Time frame: Baseline
Predictors of Treatment Outcome - Attentional Problems
Time frame: Baseline
Predictors of Treatment Outcome - Psychotic Experiences
Time frame: Baseline
Predictors of Treatment Outcome - Positive Mental Health
Time frame: Baseline
Predictors of Treatment Outcome - Stress
Time frame: Baseline
Predictors of Treatment Outcome - Threatening Life Events
Time frame: Baseline
Changes in Scores on Associated Phenotypes - Anxiety
Time frame: 3 weeks, 6 weeks
Changes in Scores on Associated Phenotypes - Depression
Time frame: 3 weeks, 6 weeks
Changes in Scores on Associated Phenotypes - Attentional Problems
Time frame: 3 weeks, 6 weeks
Changes in Scores on Associated Phenotypes - Psychotic Experiences
Time frame: 6 weeks
Changes in Scores on Associated Phenotypes - Positive Mental Health
Time frame: 3 weeks, 6 weeks
Changes in Scores on Associated Phenotypes - Stress
Time frame: 3 weeks, 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21886353Kessler RC, Berglund PA, Coulouvrat C, Hajak G, Roth T, Shahly V, Shillington AC, Stephenson JJ, Walsh JK. Insomnia and the performance of US workers: results from the America insomnia survey. Sleep. 2011 Sep 1;34(9):1161-71. doi: 10.5665/SLEEP.1230.
- Background: PubMed 11584515Harvey AG. Insomnia: symptom or diagnosis? Clin Psychol Rev. 2001 Oct;21(7):1037-59. doi: 10.1016/s0272-7358(00)00083-0.
- Background: PubMed 17162986Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, Lichstein KL. Psychological and behavioral treatment of insomnia:update of the recent evidence (1998-2004). Sleep. 2006 Nov;29(11):1398-414. doi: 10.1093/sleep/29.11.1398.
- Background: PubMed 22654196Espie 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.
- Background: PubMed 23772677Hudson JL, Lester KJ, Lewis CM, Tropeano M, Creswell C, Collier DA, Cooper P, Lyneham HJ, Morris T, Rapee RM, Roberts S, Donald JA, Eley TC. Predicting outcomes following cognitive behaviour therapy in child anxiety disorders: the influence of genetic, demographic and clinical information. J Child Psychol Psychiatry. 2013 Oct;54(10):1086-94. doi: 10.1111/jcpp.12092. Epub 2013 Jun 18.
- Background: PubMed 26004660Hudson JL, Keers R, Roberts S, Coleman JR, Breen G, Arendt K, Bogels S, Cooper P, Creswell C, Hartman C, Heiervang ER, Hotzel K, In-Albon T, Lavallee K, Lyneham HJ, Marin CE, McKinnon A, Meiser-Stedman R, Morris T, Nauta M, Rapee RM, Schneider S, Schneider SC, Silverman WK, Thastum M, Thirlwall K, Waite P, Wergeland GJ, Lester KJ, Eley TC. Clinical Predictors of Response to Cognitive-Behavioral Therapy in Pediatric Anxiety Disorders: The Genes for Treatment (GxT) Study. J Am Acad Child Adolesc Psychiatry. 2015 Jun;54(6):454-63. doi: 10.1016/j.jaac.2015.03.018. Epub 2015 Apr 1.
- Background: PubMed 22024766Eley TC, Hudson JL, Creswell C, Tropeano M, Lester KJ, Cooper P, Farmer A, Lewis CM, Lyneham HJ, Rapee RM, Uher R, Zavos HM, Collier DA. Therapygenetics: the 5HTTLPR and response to psychological therapy. Mol Psychiatry. 2012 Mar;17(3):236-7. doi: 10.1038/mp.2011.132. Epub 2011 Oct 25. No abstract available.
- Background: PubMed 25226553Roberts S, Lester KJ, Hudson JL, Rapee RM, Creswell C, Cooper PJ, Thirlwall KJ, Coleman JR, Breen G, Wong CC, Eley TC. Serotonin transporter [corrected] methylation and response to cognitive behaviour therapy in children with anxiety disorders. Transl Psychiatry. 2014 Sep 16;4(9):e444. doi: 10.1038/tp.2014.83.
- Background: PubMed 23419741Vgontzas AN, Fernandez-Mendoza J, Liao D, Bixler EO. Insomnia with objective short sleep duration: the most biologically severe phenotype of the disorder. Sleep Med Rev. 2013 Aug;17(4):241-54. doi: 10.1016/j.smrv.2012.09.005. Epub 2013 Feb 16.
- Derived from this study: PubMed 30544141Denis D, Poerio GL, Derveeuw S, Badini I, Gregory AM. Associations between exploding head syndrome and measures of sleep quality and experiences, dissociation, and well-being. Sleep. 2019 Feb 1;42(2). doi: 10.1093/sleep/zsy216.
- Derived from this study: PubMed 29196479Denis D, Eley TC, Rijsdijk F, Zavos HMS, Keers R, Espie CA, Luik AI, Badini I, Derveeuw S, Romero A, Hodsoll J, Gregory AM. Sleep Treatment Outcome Predictors (STOP) Pilot Study: a protocol for a randomised controlled trial examining predictors of change of insomnia symptoms and associated traits following cognitive-behavioural therapy for insomnia in an unselected sample. BMJ Open. 2017 Dec 1;7(11):e017177. doi: 10.1136/bmjopen-2017-017177.
- Sleepio website - the online CBT platform used in the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Alice M Gregory, PhD principal investigator
Goldsmiths, University of London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online CBT for insomnia in people with Sleep Problem, run by King's College London at 3 sites 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 3 inclusion and 3 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 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 16 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Improvement in Insomnia Symptoms Following Online CBT (time frame: Change from baseline to 3 weeks, 6 weeks, and 6 months). 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 NCT03062891, which also lists 11 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 16 Jul 2020.