Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Daniel Freeman, Bryony Sheaves, Guy M. Goodwin, Ly-Mee Yu, Paul J. Harrison, Richard Emsley, Sophie Bostock, Russell G. Foster, Vanashree Wadekar, Christopher Hinds, Colin A. Espie

Published in: Trials | Issue 1/2015

Login to get access

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.
Literature
1.
Harvey AG, Murray G, Chandler RA, Soehner A. Sleep disturbance as transdiagnostic: consideration of neurobiological mechanisms. Clin Psychol Rev. 2011;31:225–35.CrossRefPubMed
2.
3.
Foster RG, Peirson SN, Wulff K, Winnebeck E, Vetter C, Roenneberg T. Sleep and circadian rhythm disruption in social jetlag and mental illness. Prog Mol Biol Transl Sci. 2013;119:325–46.CrossRefPubMed
4.
Kendler KS, Campbell J. Interventionist causal models in psychiatry: repositioning the mind-body problem. Psychol Med. 2009;39:881–7.CrossRefPubMed
5.
Ohayon M. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6:97–111.CrossRefPubMed
6.
Morphy H, Dunn KM, Lewis M, Boardman HF, Croft PR. Epidemiology of insomnia: a longitudinal study in a UK population. Sleep. 2007;30:274–80.PubMed
7.
Walsh JK. Clinical and socioeconomic correlates of insomnia. J Clin Psychiatry. 2004;65 Suppl 8:13–9.PubMed
8.
Morin CM, Bélanger L, LeBlanc M, Ivers H, Savard J, Espie CA, et al. The natural history of insomnia: A Population-based 3-year longitudinal study. Arch Intern Med. 2009;169:447–53.CrossRefPubMed
9.
Okajima I, Komada Y, Inoue Y. A meta-analysis on the treatment effectiveness of cognitive behavioral therapy for primary insomnia. Sleep Biol Rhythms. 2011;9:24–34.CrossRef
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.CrossRefPubMed
11.
Smith MT, Perlis ML, Park A, Smith MS, Pennington J, Giles DE, et al. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002;159:5–11.CrossRefPubMed
12.
13.
Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008;4:487–504.PubMedPubMedCentral
14.
Vázquez-Barquero JL, Lastra I, Cuesta Nunez MJ, Herrera Castanedo S, Dunn G. Patterns of positive and negative symptoms in first episode schizophrenia. Br J Psychiatry. 1996;168:693–701.CrossRefPubMed
15.
Wigman JTW, Vollebergh WAM, Raaijmakers QAW, Iedema J, van Dorsselaer S, Ormel J, et al. The structure of the extended psychosis phenotype in early adolescence–a cross-sample replication. Schizophr Bull. 2011;37:850–60.CrossRefPubMed
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.CrossRefPubMed
17.
Freeman D, Garety P, Bebbington PE, Smith B, Rollinson R, Fowler D, et al. Psychological investigation of the structure of paranoia in a non-clinical population. Br J Psychiatry. 2005;186:427–35.CrossRefPubMed
18.
Bebbington PE, McBride O, Steel C, Kuipers E, Radovanovic M, Brugha T, et al. The structure of paranoia in the general population. Br J Psychiatry. 2013;202:419–27.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMedPubMedCentral
21.
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.CrossRefPubMedPubMedCentral
23.
Freeman D, Stahl D, McManus S, Meltzer H, Brugha T, Wiles N, et al. Insomnia, worry, anxiety and depression as predictors of the occurrence and persistence of paranoid thinking. Soc Psychiatry Psychiatr Epidemiol. 2012;47:1195–203.CrossRefPubMed
24.
Freeman D, Thompson C, Vorontsova N, Dunn G, Carter L-A, Garety P, et al. Paranoia and post-traumatic stress disorder in the months after a physical assault. Psychol Med. 2013;43:2673–84.CrossRefPubMedPubMedCentral
25.
26.
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.CrossRefPubMed
28.
Pritchett D, Wulff K, Oliver PL, Bannerman DM, Davies KE, Harrison PJ, et al. Evaluating the links between schizophrenia and sleep and circadian rhythm disruption. J Neural Transm. 2012;119:1061–75.CrossRefPubMed
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.CrossRefPubMedPubMedCentral
30.
Freeman D, Startup H, Myers E, Harvey A, Geddes J, Yu L-M, et al. 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.CrossRefPubMedPubMedCentral
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.CrossRefPubMed
32.
Espie C, Kyle S, Williams C, Ong J, Douglas N, Hames P, et al. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012;35:769–81.CrossRefPubMedPubMedCentral
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.CrossRef
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.CrossRefPubMedPubMedCentral
35.
Hewitt CE, Torgerson DJ. Is restricted randomisation necessary? Br Med J. 2006;332(June):1506–8.CrossRef
36.
Espie CA, MacMahon KM, Kelly H-L, Broomfield NM, Douglas NJ, Engleman HM, et al. Randomized clinical effectiveness trial of nurse-administered small-group cognitive behavior therapy for persistent insomnia in general practice. Sleep. 2007;30:574–84.PubMed
37.
Espie CA, Fleming L, Cassidy J, Samuel L, Taylor LM, White CA, et al. Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer. J Clin Oncol. 2008;26:4651–8.CrossRefPubMed
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.CrossRefPubMed
39.
Green CEL, Freeman D, Kuipers E, Bebbington P, Fowler D, Dunn G, et al. Measuring ideas of persecution and social reference: the Green et al. Paranoid Thought Scales (GPTS). Psychol Med. 2008;38:101–11.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.PubMedPubMedCentral
43.
Krakow BJ, Melendrez DC, Johnston LG, Clark JO, Santana EM, Warner TD, et al. Sleep dynamic therapy for Cerro Grande fire evacuees. J Clin Psychiatry. 2002;63:673–84.CrossRefPubMed
44.
Horne JA, Östberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4:97–100.PubMed
45.
Ising HK, Veling W, Loewy RL, Rietveld MW, Rietdijk J, Dragt S, et al. The validity of the 16-item version of the Prodromal Questionnaire (PQ-16) to screen for ultra high risk of developing psychosis in the general help-seeking population. Schizophr Bull. 2012;38:1288–96.CrossRefPubMedPubMedCentral
46.
Kroenke K, Spitzer RL, Williams JBW, Löwe B. The Patient Health Questionnaire somatic, anxiety, and depressive symptom scales: a systematic review. Gen Hosp Psychiatry. 2010;32:345–59.CrossRefPubMed
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.CrossRefPubMed
48.
Kroenke K, Spitzer RL, Williams JBW, Löwe B. An ultra-brief screening scale for anxiety and depression: the PHQ–4. Psychosomatics. 2009;50:613–21.PubMed
49.
Altman EG, Hedeker D, Peterson JL, Davis JM. The Altman self-rating mania scale. Biol Psychiatry. 1997;42:948–55.CrossRefPubMed
50.
Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, et al. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007;5:63.CrossRefPubMedPubMedCentral
51.
Mundt JC, Marks IM, Shear MK, Greist JM. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002;180:461–4.CrossRefPubMed
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.CrossRefPubMed
53.
Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726–32.CrossRefPubMed
54.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.CrossRefPubMedPubMedCentral
55.
Chan A, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Hro A, et al. Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;2013(158):200–7.CrossRef
56.
Chan A, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration : guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
57.
Emsley R, Dunn G, White IR. Mediation and moderation of treatment effects in randomised controlled trials of complex interventions. Stat Methods Med Res. 2010;19(3):237–70.CrossRefPubMed
58.
Freeman D, Dunn G, Startup H, Pugh K, Cordwell J, Mander H, et al. Effects of cognitive behaviour therapy for worry on persecutory delusions in patients with psychosis (WIT): a parallel, single-blind, randomised controlled trial with a mediation analysis. The Lancet Psychiatry. 2015;2:305–13.CrossRefPubMedPubMedCentral
59.
Gosling JA, Glozier N, Griffiths K, Ritterband L, Thorndike F, Mackinnon A, et al. The GoodNight study–online CBT for insomnia for the indicated prevention of depression: study protocol for a randomised controlled trial. Trials. 2014;15:56.CrossRefPubMedPubMedCentral
Metadata
Title
Effects of cognitive behavioural therapy for insomnia on the mental health of university students: study protocol for a randomized controlled trial
Authors
Daniel Freeman
Bryony Sheaves
Guy M. Goodwin
Ly-Mee Yu
Paul J. Harrison
Richard Emsley
Sophie Bostock
Russell G. Foster
Vanashree Wadekar
Christopher Hinds
Colin A. Espie
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0756-4

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Study protocol

Pit excision with phenolisation of the sinus tract versus radical excision in sacrococcygeal pilonidal sinus disease: study protocol for a single centre randomized controlled trial

Study protocol

Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial

Review

Quality of outcome reporting in phase II studies in pulmonary tuberculosis

Update

Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control: the CopenHeartVR trial

Study protocol

Wrist-ankle acupuncture (WAA) for precompetition nervous syndrome: study protocol for a randomized controlled trial

Review

Adding a treatment arm to an ongoing clinical trial: a review of methodology and practice