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

Trials

Volumn 16, Issue 1, 2015, Pages

  Freeman, Daniel ^a   Sheaves, Bryony ^a   Goodwin, Guy M ^a   Yu, Ly Mee ^b   Harrison, Paul J ^a   Emsley, Richard ^c   Bostock, Sophie ^d   Foster, Russell G ^b   Wadekar, Vanashree ^b   Hinds, Christopher ^b   Espie, Colin A ^b,d  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c UNIVERSITY OF MANCHESTER   (United Kingdom)

^d Sleepio Limited   (United Kingdom)

Author keywords

CBT; Delusions; Hallucinations; Insomnia; Schizophrenia; Sleep

Indexed keywords

ADULT; ANXIETY; ARTICLE; COGNITIVE THERAPY; CONTROLLED STUDY; DEPRESSION; FOLLOW UP; HALLUCINATION; HUMAN; INSOMNIA; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MANIA; MENTAL DISEASE; MENTAL HEALTH; NIGHTMARE; PARANOIA; PSYCHOLOGICAL WELL BEING; PSYCHOSIS; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; SLEEP DISORDER; UNITED KINGDOM; UNIVERSITY STUDENT; ADOLESCENT; CLINICAL PROTOCOL; CLINICAL TRIAL; FEMALE; HALLUCINATIONS; MALE; METHODOLOGY; MULTICENTER STUDY; PARANOID DISORDERS; PSYCHOLOGICAL RATING SCALE; PSYCHOLOGY; SLEEP; SLEEP INITIATION AND MAINTENANCE DISORDERS; STUDENT; TIME FACTOR; TREATMENT OUTCOME; UNIVERSITY; YOUNG ADULT;

ADOLESCENT; ADULT; CLINICAL PROTOCOLS; COGNITIVE THERAPY; FEMALE; HALLUCINATIONS; HUMANS; INTENTION TO TREAT ANALYSIS; MALE; MENTAL HEALTH; PARANOID BEHAVIOR; PARANOID DISORDERS; PSYCHIATRIC STATUS RATING SCALES; RESEARCH DESIGN; SINGLE-BLIND METHOD; SLEEP; SLEEP INITIATION AND MAINTENANCE DISORDERS; STUDENTS; TIME FACTORS; TREATMENT OUTCOME; UNITED KINGDOM; UNIVERSITIES; YOUNG ADULT;

EID: 84930652443     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0756-4     Document Type: Article

References (59)

1. Harvey AG, Murray G, Chandler RA, Soehner A. Sleep disturbance as transdiagnostic: consideration of neurobiological mechanisms. Clin Psychol Rev. 2011;31:225-35.
2. Anderson KN, Bradley AJ. Sleep disturbance in mental health problems and neurodegenerative disease. Nat Sci Sleep. 2013;5:61-75.
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.
4. Kendler KS, Campbell J. Interventionist causal models in psychiatry: repositioning the mind-body problem. Psychol Med. 2009;39:881-7.
5. Ohayon M. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6:97-111.
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.
7. Walsh JK. Clinical and socioeconomic correlates of insomnia. J Clin Psychiatry. 2004;65 Suppl 8:13-9.
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.
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.
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.
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.
12. Morin CM, Benca R. Chronic insomnia. Lancet. 2012;379:1129-41.
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.
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.
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.
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.
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.
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.
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.
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.
21. Freeman D, Pugh K, Vorontsova N, Southgate L. Insomnia and paranoia. Schizophr Res. 2009;108:280-4.
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.
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.
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.
25. Taylor M, Gregory A, Freeman D, Ronald A. Do sleep disturbances and psychotic like experiences in adolescence share genetic and environmental influences? (i2015). J Abnorm Psychol. EPub ahead of publication May 5th 2015. http://dx.doi.org/10.1037/abn0000057
26. Wulff K, Dijk D-J, Middleton B, Foster RG, Joyce EM. Sleep and circadian rhythm disruption in schizophrenia. Br J Psychiatry. 2012;200:308-16.
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.
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.
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.
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.
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.
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.
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.
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.
35. Hewitt CE, Torgerson DJ. Is restricted randomisation necessary? Br Med J. 2006;332(June):1506-8.
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.
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.
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.
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.
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.
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.
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.
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.
44. Horne JA, Östberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4:97-100.
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.
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.
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.
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.
49. Altman EG, Hedeker D, Peterson JL, Davis JM. The Altman self-rating mania scale. Biol Psychiatry. 1997;42:948-55.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.