Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Daniel Freeman


Contact details

University Department of Psychiatry
Warneford Lane
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Better Sleep Trial: a pilot randomised controlled trial for patients with delusions and/or hallucinations


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

Ethics approval

First MREC, 23/04/2012, ref: 12/SC/0138

Study design

Randomised interventional trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet




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



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


Overall trial end date


Reason abandoned


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
United Kingdom

Sponsor information


University of Oxford (UK)

Sponsor details

Nuffield Department
Obstetrics and Gynaecology
Division of Medical Sciences
United Kingdom

Sponsor type




Funder type


Funder name

NIHR Research for Patient Benefit Programme ref: PB-PG-0211-10007 (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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:
2015 results in:

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