Sleep Treatment Outcome Predictors: A Pilot Study (STOP-pilot)

NCT03062891 | Completed Results

• 1 other identifier: STOP-0001-PILOT
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

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. 1.Does the online CBT intervention improve sleep quality in a non-clinical, unselected sample?
2. 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.
3. 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. 4.Which demographic, clinical, genetic, and epigenetic factors predict treatment outcome for sleep problems?

Conditions

Sleep Problem

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  6 months

Secondary Outcomes (13)

• Predictors of Treatment Outcome - Anxiety

  Baseline

• Predictors of Treatment Outcome - Depression

  Baseline

• Predictors of Treatment Outcome - Attentional Problems

  Baseline

• Predictors of Treatment Outcome - Psychotic Experiences

  Baseline

• Predictors of Treatment Outcome - Positive Mental Health

  Baseline

Other Outcomes (2)

• Online CBT for Insomnia in Sleep Paralysis

  Change from baseline to 6 weeks

• Phenotypic Associations With Exploding Head Syndrome

  Baseline

Study Arms (2)

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).

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).

Interventions

Online CBT for insomnia PROCEDURE

See CBT arm description for information about the CBT intervention. More details can be found in source 4 in the reference list.

Online CBT for insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King's College London: lead
• Goldsmiths, University of London: collaborator
• Queen Mary University of London: collaborator
• University of Oxford: collaborator

Study Sites (3)

Queen Mary, University of London

London, E1 4NS, United Kingdom

Location

Goldsmiths, University of London

London, SE14 6NW, United Kingdom

Location

King's College London

London, WC2R 2LS, United Kingdom

Location

Related Publications (11)

• 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.

  PMID: 21886353 BACKGROUND

• Harvey AG. Insomnia: symptom or diagnosis? Clin Psychol Rev. 2001 Oct;21(7):1037-59. doi: 10.1016/s0272-7358(00)00083-0.

  PMID: 11584515 BACKGROUND

• 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.

  PMID: 17162986 BACKGROUND

• 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.

  PMID: 22654196 BACKGROUND

• 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.

  PMID: 23772677 BACKGROUND

• 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.

  PMID: 26004660 BACKGROUND

• 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.

  PMID: 22024766 BACKGROUND

• 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.

  PMID: 25226553 BACKGROUND

• 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.

  PMID: 23419741 BACKGROUND

• 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.

  PMID: 30544141 DERIVED

• 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.

  PMID: 29196479 DERIVED

Related Links

• Sleepio website - the online CBT platform used in the study

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Dan Denis
• Organization: University of Notre Dame

ddenis@nd.edu

6178066484

Study Officials

• Alice M Gregory, PhD

  Goldsmiths, University of London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: February 24, 2017
• Study Start: November 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 16, 2020
• Results First Posted: July 16, 2020

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)