title: 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.
abstract: BACKGROUND
  Patients with psychosis frequently report difficulties getting or staying asleep (insomnia). Dissatisfaction with sleep is high. Insomnia should be treated in this group, but typically it is not even assessed. Importantly, recent evidence indicates that insomnia triggers and exacerbates delusions and hallucinations. The clinical implication is that if the insomnia is treated then the psychotic symptoms will significantly lessen. In a case series with 15 patients with persecutory delusions resistant to previous treatment this is exactly what we found: cognitive behavioural therapy for insomnia (CBT-I) led to large reductions in both the insomnia and delusions. The clear next step is a pilot randomized controlled test. The clinical aim is to test whether CBT-I can reduce both insomnia and psychotic symptoms. The trial will inform decisions for a definitive large-scale evaluation.
  
  
  METHODS
  We will carry out a randomized controlled trial (the Better Sleep Trial, or the BEST study) with 60 patients with distressing delusions or hallucinations in the context of a schizophrenia spectrum diagnosis. Half of the participants will be randomized to receive CBT-I, in addition to their standard treatment, for up to eight sessions over 12 weeks. The other half will continue with treatment as usual. Blind assessments will take place at 0 weeks, 12 weeks (post-treatment) and 24 weeks (follow-up). The primary outcome hypotheses are that CBT-I added to treatment as usual will improve sleep, delusions and hallucinations compared with only treatment as usual. All main analyses will be carried out at the end of the last follow-up assessments and will be based on the intention-to-treat principle. The trial is funded by the NHS National Institute for Health Research (NIHR) Research for Patient Benefit Programme. Data collection will be complete by the end of 2014.
  
  
  CONCLUSIONS
  This will be the first controlled test of CBT-I for patients with delusions and hallucinations. It will provide significant evidence for an easily administered intervention that is likely to prove very popular with patients experiencing the difficult-to-treat problems of delusions and hallucinations.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN 33695128.
authors.affiliation: Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK. Daniel.Freeman@psych.ox.ac.uk
authors.forename: Daniel
authors.initials: D
authors.lastname: Freeman
authors.forename: Helen
authors.initials: H
authors.lastname: Startup
authors.forename: Elissa
authors.initials: E
authors.lastname: Myers
authors.forename: Allison
authors.initials: A
authors.lastname: Harvey
authors.forename: John
authors.initials: J
authors.lastname: Geddes
authors.forename: Ly-Mee
authors.initials: LM
authors.lastname: Yu
authors.forename: Zenobia
authors.initials: Z
authors.lastname: Zaiwalla
authors.forename: Ramon
authors.initials: R
authors.lastname: Luengo-Fernandez
authors.forename: Russell
authors.initials: R
authors.lastname: Foster
authors.forename: Rachel
authors.initials: R
authors.lastname: Lister
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D015928:Cognitive Behavioral Therapy; D003702:Delusions / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy; D004739:England; D006212:Hallucinations / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy; D010865:Pilot Projects; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D012559:Schizophrenia / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D012565:Schizophrenic Psychology; D012890:Sleep; D007319:Sleep Initiation and Maintenance Disorders / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D016032:Randomized Controlled Trials as Topic