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

Rachel Lister⁴  Russell Foster²  Ramon Luengo-Fernandez³  Zenobia Zaiwalla⁵  Ly-Mee Yu¹  John Geddes⁴  Allison Harvey⁶  Elissa Myers⁴  Helen Startup⁴  Daniel Freeman⁴ 

[1] Centre for Statistics in Medicine, University of Oxford, Wolfson College Annexe, Linton Road, Oxford OX2 6UD, UK;Nuffield Laboratory of Ophthalmology, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU, UK;Health Economics Research Centre, Department of Public Health, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, UK;Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK;Oxford Non-respiratory Sleep Disorder Service, Oxford University Hospitals NHS Trust, John Radcliffe Hospital, Oxford OX3 9DU, UK;Department of Psychology, University of California, Berkeley, 3210 Tolman Hall, Berkeley CA 94720-1650, USA

关键词: Sleep;    Schizophrenia;    Insomnia;    Hallucinations;    Delusions;    CBT;   

Others  :  1093430
DOI  :  10.1186/1745-6215-14-214

 received in 2013-01-21, accepted in 2013-07-01,  发布年份 2013

【 摘 要 】

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/design

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.

Discussion

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.

Trial registration

Current Controlled Trials ISRCTN 33695128

【 授权许可】

   
2013 Freeman et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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