CoChat
Sign Up
Cited by 35Sleep and related disordersPsychological Treatments and AssessmentsDigital Mental Health Interventions

Effects of cognitive behavioural therapy for insomnia on the mental health of university students: study protocol for a randomized controlled trial

Open access
Freeman, Daniel, Sheaves, Bryony, Goodwin, Guy M., Yu, Ly-Mee, Harrison, Paul J., Emsley, Richard, Bostock, Sophie, Foster, Russell G. +3 more·2015·Trials
DOI 10.1186/s13063-015-0756-4PMC PMC4448545
Open this paper in CoChat — free accountOpen PDF

Abstract

BACKGROUND: Insomnia, defined as repeated difficulties getting or staying asleep, is common in the general population. Such sleep difficulties are a problem in their own right, but increasingly it is being recognised that they may also be a contributory factor in the development of a wide range of mental health problems. Our focus is upon the relationship between insomnia and psychotic experiences, such as paranoia and hallucinations. Psychotic experiences commonly occur in mild forms in the general population and have been linked to disrupted sleep. These psychotic-like experiences raise the risk of development of a clinical disorder. Our aim is to reduce insomnia in a large general population group, and examine the effect on paranoia and hallucinations at the age when mental health problems typically emerge. The primary hypotheses are that cognitive behaviour therapy (CBT) for insomnia will reduce insomnia and also levels of paranoia and hallucinations. The theoretical links will be substantiated by a planned mediation analysis. Improvements in a number of other mental health outcomes are also predicted. METHODS/DESIGN: We will carry out a parallel group, randomised controlled trial of 2,614 students with insomnia in universities across the UK. In the Oxford Access for Students Improving Sleep (OASIS) trial, participants will be randomised to digital CBT for insomnia (in addition to treatment as usual) or treatment as usual. Online assessments will take place at zero, three, 10 (post-treatment), and 22 (follow-up) weeks. Primary outcomes are insomnia and psychotic-like experiences (paranoia or hallucinatory experiences) at 10 weeks. Secondary outcomes are levels of mania, depression, anxiety, nightmares, psychological wellbeing, and the development of mental health disorders. All main analyses will be carried out at the end of the last follow-up assessment and will be based on the intention-to-treat principle. The trial is funded by the Wellcome Trust. DISCUSSION: This study will be the first large-scale causal test of the relationship between sleep disturbance and psychotic experiences. It will provide evidence concerning the clinical effects of treating insomnia in young adults. TRIAL REGISTRATION: This trial was registered with Current Controlled Trials (identifier: ISRCTN61272251 ) on 29 January 2015.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1186/s13063-015-0756-4

Cites

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Many sleep disorders have existing effective treatments, which are beginning to be validated in psychiatric groups.

    “Yet many sleep disorders have existing effective treatments, which are beginning to be validated in psychiatric groups (e.g. Freeman et al., 2015, Myers et al., 2011).”

    From The role of sleep dysfunction in the occurrence of delusions and hallucinations: A systematic review (2015) · cites this paper as Freeman et al., 2015

    The Background > Insomnia section (page unavailable) reports sustained improvements in insomnia with CBT. Background > Insomnia and psychotic experiences (page unavailable) describes a pilot case series in patients with persecutory delusions and an ongoing trial in patients with delusions and hallucinations. This supports insomnia treatment as an example being tested in psychiatric groups, but the paper does not establish the claim about many sleep disorders. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

The citation lists haven’t been fetched yet

References 61 · Cited by 35

Research works printed but not linked: 37

  1. [1]Harvey AG Murray G Chandler RA Soehner A Sleep disturbance as transdiagnostic: consideration of neurobiological mechanisms Clin Psychol Rev. 2011 31 225 35 10.1016/j.cpr.2010.04.003 20471738 PMC2954256 · DOI · Paper page
  2. [2]Anderson KN Bradley AJ Sleep disturbance in mental health problems and neurodegenerative disease Nat Sci Sleep. 2013 5 61 75 10.2147/NSS.S34842 23761983 PMC3674021 · DOI
  3. [4]Kendler KS Campbell J Interventionist causal models in psychiatry: repositioning the mind-body problem Psychol Med. 2009 39 881 7 10.1017/S0033291708004467 18845010 · DOI · Paper page
  4. [5]Ohayon M Epidemiology of insomnia: what we know and what we still need to learn Sleep Med Rev. 2002 6 97 111 10.1053/smrv.2002.0186 12531146 · DOI · Paper page
  5. [7]Walsh JK Clinical and socioeconomic correlates of insomnia J Clin Psychiatry. 2004 65 Suppl 8 13 9 15153063
  6. [10]Irwin MR Cole JC Nicassio PM Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age Health Psychol. 2006 25 3 14 10.1037/0278-6133.25.1.3 16448292 · DOI · Paper page
  7. [15]Wigman JTW Vollebergh WAM Raaijmakers QAW Iedema J van Dorsselaer S Ormel J The structure of the extended psychosis phenotype in early adolescence–a cross-sample replication Schizophr Bull. 2011 37 850 60 10.1093/schbul/sbp154 20044595 PMC3122288 · DOI
  8. [16]Ronald A Sieradzka D Cardno AG Haworth CM McGuire P Freeman D Characterization of psychotic experiences in adolescence using the Specific Psychotic Experiences Questionnaire: findings from a study of 5000 16-year-old twins Schizophr Bull. 2014 40 868 77 10.1093/schbul/sbt106 24062593 PMC4059437 · DOI · Paper page
  9. [17]Freeman D Garety P Bebbington PE Smith B Rollinson R Fowler D Psychological investigation of the structure of paranoia in a non-clinical population Br J Psychiatry. 2005 186 427 35 10.1192/bjp.186.5.427 15863749 · DOI · Paper page
  10. [18]Bebbington PE McBride O Steel C Kuipers E Radovanovic M Brugha T The structure of paranoia in the general population Br J Psychiatry. 2013 202 419 27 10.1192/bjp.bp.112.119032 23661767 · DOI · Paper page
  11. [19]Wong KK Freeman D Hughes C Suspicious young minds: paranoia and mistrust in 8- to 14-year-olds in the U.K. and Hong Kong Br J Psychiatry 2014 205 221 9 10.1192/bjp.bp.113.135467 25012682 · DOI
  12. [20]Dominguez MDG Wichers M Lieb R Wittchen H-U van Os J Evidence that onset of clinical psychosis is an outcome of progressively more persistent subclinical psychotic experiences: an 8-year cohort study Schizophr Bull. 2009 37 84 93 10.1093/schbul/sbp022 19460881 PMC3004179 · DOI
  13. [22]Freeman D Brugha T Meltzer H Jenkins R Stahl D Bebbington P Persecutory ideation and insomnia: findings from the second British National Survey of Psychiatric Morbidity J Psychiatr Res. 2010 44 1021 6 10.1016/j.jpsychires.2010.03.018 20434169 PMC2977847 · DOI · Paper page
  14. [24]Freeman D Thompson C Vorontsova N Dunn G Carter L-A Garety P Paranoia and post-traumatic stress disorder in the months after a physical assault Psychol Med. 2013 43 2673 84 10.1017/S003329171300038X 23531413 PMC3821375 · DOI · Paper page
  15. [27]Wulff K Gatti S Wettstein JG Foster RG Sleep and circadian rhythm disruption in psychiatric and neurodegenerative disease Nat Rev Neurosci. 2010 11 589 99 10.1038/nrn2868 20631712 · DOI · Paper page
  16. [28]Pritchett D Wulff K Oliver PL Bannerman DM Davies KE Harrison PJ Evaluating the links between schizophrenia and sleep and circadian rhythm disruption J Neural Transm. 2012 119 1061 75 10.1007/s00702-012-0817-8 22569850 · DOI
  17. [29]Myers E Startup H Freeman D Cognitive behavioural treatment of insomnia in individuals with persistent persecutory delusions: a pilot trial J Behav Ther Exp Psychiatry. 2011 42 330 6 10.1016/j.jbtep.2011.02.004 21367359 PMC3566479 · DOI · Paper page
  18. [30]Freeman D Startup H Myers E Harvey A Geddes J Yu L-M The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomized controlled trial Trials. 2013 14 214 10.1186/1745-6215-14-214 23845104 PMC3717119 · DOI
  19. [31]Laursen TM Munk-Olsen T Nordentoft M Bo MP A comparison of selected risk factors for unipolar depressive disorder, bipolar affective disorder, schizoaffective disorder, and schizophrenia from a danish population-based cohort J Clin Psychiatry. 2007 68 1673 81 10.4088/JCP.v68n1106 18052560 · DOI
  20. [33]Espie C Hames P McKinstry B Use of the internet and mobile media for delivery of cognitive behavioral insomnia therapy Sleep Med Clin. 2013 8 407 19 10.1016/j.jsmc.2013.06.001 · DOI
  21. [34]Espie CA Kyle SD Hames P Gardani M Fleming L Cape J The Sleep Condition Indicator: a clinical screening tool to evaluate insomnia disorder BMJ Open. 2014 4 e004183 10.1136/bmjopen-2013-004183 24643168 PMC3964344 · DOI · Paper page
  22. [35]Hewitt CE Torgerson DJ Is restricted randomisation necessary? Br Med J 2006 332 June 1506 8 10.1136/bmj.332.7556.1506 16793819 PMC1482349 · DOI
  23. [36]Espie CA MacMahon KM Kelly H-L Broomfield NM Douglas NJ Engleman HM Randomized clinical effectiveness trial of nurse-administered small-group cognitive behavior therapy for persistent insomnia in general practice Sleep. 2007 30 574 84 17552372
  24. [38]Espie CA Inglis SJ Harvey L Predicting clinically significant response to cognitive behaviour therapy for chronic insomnia in general medical practice: analysis of outcome data at 12 months posttreatment J Consult Clin Psychol. 2001 69 58 66 10.1037/0022-006X.69.1.58 11302278 · DOI
  25. [40]Bell V Halligan PW Ellis HD The Cardiff Anomalous Perceptions Scale (CAPS): a new validated measure of anomalous perceptual experience Schizophr Bull. 2006 32 366 77 10.1093/schbul/sbj014 16237200 PMC2632213 · DOI · Paper page
  26. [41]Bastien CH Vallières A Morin CM Validation of the Insomnia Severity Index as an outcome measure for insomnia research Sleep Med. 2001 2 297 307 10.1016/S1389-9457(00)00065-4 11438246 · DOI · Paper page
  27. [42]Morin CM Belleville G Bélanger L Ivers H The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response Sleep. 2011 34 601 8 21532953 PMC3079939
  28. [43]Krakow BJ Melendrez DC Johnston LG Clark JO Santana EM Warner TD Sleep dynamic therapy for Cerro Grande fire evacuees J Clin Psychiatry. 2002 63 673 84 10.4088/JCP.v63n0804 12197447 · DOI
  29. [44]Horne JA Östberg O A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms Int J Chronobiol. 1976 4 97 100 1027738
  30. [47]Spitzer RL Kroenke K Williams JBW Löwe B A brief measure for assessing generalized anxiety disorder: the GAD-7 Arch Intern Med. 2006 166 1092 7 10.1001/archinte.166.10.1092 16717171 · DOI · Paper page
  31. [49]Altman EG Hedeker D Peterson JL Davis JM The Altman self-rating mania scale Biol Psychiatry. 1997 42 948 55 10.1016/S0006-3223(96)00548-3 9359982 · DOI
  32. [50]Tennant R Hiller L Fishwick R Platt S Joseph S Weich S The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation Health Qual Life Outcomes. 2007 5 63 10.1186/1477-7525-5-63 18042300 PMC2222612 · DOI · Paper page
  33. [52]Freeman D Lister R Evans N The use of intuitive and analytic reasoning styles by patients with persecutory delusions J Behav Ther Exp Psychiatry. 2014 45 454 8 10.1016/j.jbtep.2014.06.005 25000504 · DOI · Paper page
  34. [54]Moher D Hopewell S Schulz KF Montori V Gøtzsche PC Devereaux PJ CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials BMJ. 2010 340 c869 10.1136/bmj.c869 20332511 PMC2844943 · DOI · Paper page
  35. [55]Chan A Tetzlaff JM Altman DG Laupacis A Gøtzsche PC Hro A Statement: defining standard protocol items for clinical trials Ann Intern Med 2013 2013 158 200 7 10.7326/0003-4819-158-3-201302050-00583 23295957 PMC5114123 · DOI · Paper page
  36. [56]Chan A Tetzlaff JM Gøtzsche PC Altman DG Mann H Berlin JA SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials BMJ. 2013 346 e7586 10.1136/bmj.e7586 23303884 PMC3541470 · DOI · Paper page
  37. [59]Gosling JA Glozier N Griffiths K Ritterband L Thorndike F Mackinnon A The GoodNight study–online CBT for insomnia for the indicated prevention of depression: study protocol for a randomised controlled trial Trials. 2014 15 56 10.1186/1745-6215-15-56 24524214 PMC3926259 · DOI

Authors
Freeman, D., Sheaves, B., Goodwin, G. M., Yu, L.-M., Harrison, P. J., Emsley, R., Bostock, S., Foster, R. G., Wadekar, V., Hinds, C., & Espie, C. A.
Affiliations
  • Warneford Hospital (GB)
  • University of Oxford (GB)
  • Manchester Academic Health Science Centre (GB)
  • John Radcliffe Hospital (GB)
Corresponding author
Freeman, Daniel
ORCID
Venue
Trials
Publisher
Springer Science and Business Media LLC
Published
2015-05-28
Volume
16
Issue
1
Pages
236-236
ISSN
1745-6215 (ISSN-L)
DOI
10.1186/s13063-015-0756-4
PMC
PMC4448545
OpenAlex
W2166378627
Cited by
35
References
61
Citations by year
2024: 2 · 2023: 1 · 2022: 5 · 2021: 3 · 2020: 4 · 2019: 1 · 2018: 2 · 2017: 6 · 2016: 9 · 2015: 2
FWCI
9.57
Type
journal article
Language
en
Open access
Licence
Locations
  • Trials (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Research Portal (King's College London) (publishedVersion, cc-by)
  • Research Explorer (The University of Manchester) (publishedVersion)
  • ePrints Soton (University of Southampton) (acceptedVersion)
Funders
  • Wellcome Trust (098461, 098461/Z/12/Z)
  • Medical Research Council (098461/Z/12/Z)
Topics
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
  • Social Sciences › Psychology › Clinical Psychology › Psychological Treatments and Assessments
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
Keywords
cognitive behavioral therapy for insomnia, insomnia, university students, young adults, paranoia, hallucinations, psychotic-like experiences, sleep disorders, mental health, depression, anxiety, mania, nightmares, psychological well-being, mediation analysis
MeSH terms
Adolescent, Adult, Clinical Protocols, Female, United Kingdom, Hallucinations, Humans, Sleep Initiation and Maintenance Disorders, Male, Mental Health, Paranoid Behavior, Paranoid Disorders, Psychiatric Status Rating Scales, Research Design, Sleep, Students, Time Factors, Universities, Multicenter Studies as Topic, Cognitive Behavioral Therapy, Randomized Controlled Trials as Topic, Single-Blind Method, Treatment Outcome, Young Adult, Intention to Treat Analysis

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review