title: Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial.
abstract: BACKGROUND
  Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)-the best evidence-based treatment for insomnia-has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit.
  
  
  METHODS
  We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18-65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128.
  
  
  RESULTS
  Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large effect size range at week 12 (adjusted mean difference 6.1, 95% CI 3.0-9.2, effect size d=1.9). By week 12, nine (41%) of 22 patients receiving CBT and one (4%) of 25 patients receiving standard care alone no longer had insomnia, with ISI scores lower than the cutoff for insomnia. The treatment effect estimation for CBT covered a range from reducing but also increasing delusions (adjusted mean difference 0.3, 95% CI -2.0 to 2.6) and hallucinations (-1.9, -6.5 to 2.7). Three patients, all in the CBT group, had five adverse events, although none were regarded as related to study treatment.
  
  
  CONCLUSIONS
  Our findings show that CBT for insomnia might be highly effective for improving sleep in patients with persistent delusions or hallucinations. A larger, suitably powered phase 3 study is now needed to provide a precise estimate of the effects of CBT for sleep problems, both on sleep and psychotic experiences.
  
  
  BACKGROUND
  Research for Patient Benefit Programme, National Institute for Health Research.
authors.affiliation: Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK. Electronic address: daniel.freeman@psych.ox.ac.uk.
authors.forename: Daniel
authors.initials: D
authors.lastname: Freeman
authors.affiliation: Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK.
authors.forename: Felicity
authors.initials: F
authors.lastname: Waite
authors.affiliation: Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK; Sussex Partnership NHS Trust, Worthing, West Sussex.
authors.forename: Helen
authors.initials: H
authors.lastname: Startup
authors.affiliation: Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK.
authors.forename: Elissa
authors.initials: E
authors.lastname: Myers
authors.affiliation: Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK.
authors.forename: Rachel
authors.initials: R
authors.lastname: Lister
authors.affiliation: Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK.
authors.forename: Josephine
authors.initials: J
authors.lastname: McInerney
authors.affiliation: Department of Psychology, University of California, Berkeley, CA, USA.
authors.forename: Allison G
authors.initials: AG
authors.lastname: Harvey
authors.affiliation: Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK.
authors.forename: John
authors.initials: J
authors.lastname: Geddes
authors.affiliation: Oxford Non-Respiratory Sleep Disorder Service, Oxford University Hospitals NHS Trust, John Radcliffe Hospital, Oxford, UK.
authors.forename: Zenobia
authors.initials: Z
authors.lastname: Zaiwalla
authors.affiliation: Health Economics Research Centre, Department of Public Health, University of Oxford, Oxford, UK.
authors.forename: Ramon
authors.initials: R
authors.lastname: Luengo-Fernandez
authors.affiliation: Sleep and Circadian Neurosciences Institute, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.
authors.forename: Russell
authors.initials: R
authors.lastname: Foster
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Lei
authors.initials: L
authors.lastname: Clifton
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
authors.forename: Ly-Mee
authors.initials: LM
authors.lastname: Yu
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy; D003702:Delusions / Q000523:psychology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006212:Hallucinations / Q000523:psychology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012893:Sleep Wake Disorders / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome