Clinical trial NCT03062891: Sleep Treatment Outcome Predictors: A Pilot Study (STOP-pilot)
Official title: Sleep Treatment Outcome Predictors: A Pilot Study (STOP-pilot)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Problem
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Goldsmiths, University of London
name: Queen Mary University of London
name: University of Oxford
First posted: 2017-02-24
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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:

1. Does the online CBT intervention improve sleep quality in a non-clinical, unselected sample?
2. 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:
3. 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.
4. 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.


Eligibility criteria: Inclusion

* Female
* Aged 18 plus
* Psychology student (undergraduate or postgraduate) at one of three London universities involved in the study.

Exclusion

* Male
* Under 18
* Not a psychology student (undergraduate or postgraduate) at one of three London universities involved in the study.

Primary outcomes:
measure: Improvement in Insomnia Symptoms Following Online CBT
timeFrame: Change from baseline to 3 weeks, 6 weeks, and 6 months
measure: Improvement in Sleep Quality Following Online CBT
timeFrame: Change from baseline to 3 weeks, 6 weeks, and 6 months
measure: Treatment Acceptability Mid-intervention
timeFrame: 3 weeks
measure: Treatment Acceptability at the End of the Intervention
timeFrame: 6 weeks
measure: Change in Treatment Acceptability During the Intervention
timeFrame: Change from baseline to 3 weeks and 6 weeks
measure: Attrition Rate
timeFrame: 6 months
Secondary outcomes:
measure: Predictors of Treatment Outcome - Anxiety
timeFrame: Baseline
measure: Predictors of Treatment Outcome - Depression
timeFrame: Baseline
measure: Predictors of Treatment Outcome - Attentional Problems
timeFrame: Baseline
measure: Predictors of Treatment Outcome - Psychotic Experiences
timeFrame: Baseline
measure: Predictors of Treatment Outcome - Positive Mental Health
timeFrame: Baseline
measure: Predictors of Treatment Outcome - Stress
timeFrame: Baseline
measure: Predictors of Treatment Outcome - Threatening Life Events
timeFrame: Baseline
measure: Changes in Scores on Associated Phenotypes - Anxiety
timeFrame: 3 weeks, 6 weeks
measure: Changes in Scores on Associated Phenotypes - Depression
timeFrame: 3 weeks, 6 weeks
measure: Changes in Scores on Associated Phenotypes - Attentional Problems
timeFrame: 3 weeks, 6 weeks
measure: Changes in Scores on Associated Phenotypes - Psychotic Experiences
timeFrame: 6 weeks
measure: Changes in Scores on Associated Phenotypes - Positive Mental Health
timeFrame: 3 weeks, 6 weeks
measure: Changes in Scores on Associated Phenotypes - Stress
timeFrame: 3 weeks, 6 weeks
Other outcomes:
measure: Online CBT for Insomnia in Sleep Paralysis
timeFrame: Change from baseline to 6 weeks
measure: Phenotypic Associations With Exploding Head Syndrome
timeFrame: Baseline
Locations:
city: London
country: United Kingdom
facility: Queen Mary, University of London
city: London
country: United Kingdom
facility: Goldsmiths, University of London
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: Goldsmiths, University of London
name: Alice M Gregory, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Harvey AG. Insomnia: symptom or diagnosis? Clin Psychol Rev. 2001 Oct;21(7):1037-59. doi: 10.1016/s0272-7358(00)00083-0.
citation: Morin 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.
citation: Espie 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.
citation: Hudson 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.
citation: Hudson 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.
citation: Eley 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.
citation: Roberts 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.
citation: Vgontzas 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.
citation: Denis 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.
citation: Denis 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.