Condition category
Mental and Behavioural Disorders
Date applied
26/09/2012
Date assigned
26/09/2012
Last edited
14/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
-
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 measures

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

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

http://www.ox.ac.uk/

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23845104
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26363701

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes