Contact information
Type
Scientific
Primary contact
Prof Daniel Freeman
ORCID ID
Contact details
University Department of Psychiatry
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
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Daniel.Freeman@psych.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12766
Study information
Scientific title
Better Sleep Trial: a pilot randomised controlled trial for patients with delusions and/or hallucinations
Acronym
Study hypothesis
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 insomnia is treated then the psychotic symptoms will significantly lessen too. In a recent case series with fifteen patients with persecutory delusions resistant to previous treatment this is exactly what we found: Cognitive Behavioural Therapy for Insomnia (CBT-I) led to large clinically significant reductions in the insomnia and the delusions. It was also a highly popular intervention with patients. The clear next step is a pilot randomised controlled test. The clinical aim is to test whether CBT-I can reduce both insomnia and psychotic symptoms (establishing treatment effect sizes). It will inform decisions for a definitive large-scale evaluation. We will carry out a randomised controlled trial with 60 patients with distressing delusions and/or hallucinations in the context of a schizophrenia spectrum diagnosis. Half of the participants will be randomised to CBT-I, in addition to their standard treatment, which will be carried out over three months. Half of the participants will continue with treatment as usual. Blind assessments will take place at 0 months, 3 months (post-treatment) and 6 months (follow-up). 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 likely to prove very popular with patients experiencing the difficult to treat problems of delusions and hallucinations.
More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12766
Ethics approval
First MREC, 23/04/2012, ref: 12/SC/0138
Study design
Randomised interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Psychosis
Intervention
CBT-I, The insomnia intervention will be provided in up to eight sessions over 12 weeks. The twelve week window will allow some flexibility for appointment times (DNAs are quite common in this group) and the extension of intervals between the final two sessions.
The main techniques, standard for CBT sleep interventions, are taken from four main sources:
Espie (2006)
Freeman & Freeman (2010)
Harvey et al. (2007)
Meir & Kryger (2004).
The intervention is written in a manual, which we will develop further. Followed up at 6 months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Insomnia Severity Index measured at 0,12, and 24 weeks
Secondary outcome measures
Psychotic Symptoms Rating Scale measured at 0,12, 24 weeks
Overall trial start date
01/11/2012
Overall trial end date
01/07/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. A current delusion and/or hallucination; scoring at least 2 on the distress scale of the PSYRATS for either a delusion or hallucination
2. The delusion and/or hallucination has persisted for at least three months
3. Clinical diagnosis of schizophrenia, schizoaffective disorder or delusional disorder (i.e. diagnosis of nonaffective psychosis (F2) in the International Classification of Diseases and Diagnostic and Statistical Manual IV)
4. Sleep difficulties lasting one month or longer and an Insomnia Severity Index score of 15 or above
5. Aged between 18 and 65
6. Where changes in medication are being made, entry to the study would not occur until at least a month after stabilisation of dosage
7. Male or female participants
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 60
Participant exclusion criteria
1. Sleep apnoea
2. A primary diagnosis of alcohol or substance dependency
3. Organic syndrome or learning disability
4. A command of spoken English inadequate for engaging in therapy
5. Currently having individual CBT (though previous CBT experience is not an exclusion criterion)
Recruitment start date
01/11/2012
Recruitment end date
01/07/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford
Oxford
OX3 7JX
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Nuffield Department
Obstetrics and Gynaecology
Division of Medical Sciences
Oxford
OX3 9DU
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Research for Patient Benefit Programme ref: PB-PG-0211-10007 (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23845104
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26363701
Publication citations
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Protocol
Freeman D, Startup H, Myers E, Harvey A, Geddes J, Yu LM, Zaiwalla Z, Luengo-Fernandez R, Foster R, Lister R, 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, doi: 10.1186/1745-6215-14-214.
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Results
Freeman D, Waite F, Startup H, Myers E, Lister R, McInerney J, Harvey AG, Geddes J, Zaiwalla Z, Luengo-Fernandez R, Foster R, Clifton L, Yu LM, Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial, Lancet Psychiatry, 2015, doi: 10.1016/S2215-0366(15)00314-4.