ISRCTN ISRCTN33695128
DOI https://doi.org/10.1186/ISRCTN33695128
Secondary identifying numbers 12766
Submission date
26/09/2012
Registration date
26/09/2012
Last edited
14/09/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Daniel Freeman
Scientific

University Department of Psychiatry
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom

Email Daniel.Freeman@psych.ox.ac.uk

Study information

Study designRandomised interventional trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleBetter Sleep Trial: a pilot randomised controlled trial for patients with delusions and/or hallucinations
Study objectivesPatients 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(s)First MREC, 23/04/2012, ref: 12/SC/0138
Health condition(s) or problem(s) studiedPsychosis
InterventionCBT-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 typeOther
Primary outcome measureInsomnia Severity Index measured at 0,12, and 24 weeks
Secondary outcome measuresPsychotic Symptoms Rating Scale measured at 0,12, 24 weeks
Overall study start date01/11/2012
Completion date01/07/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsUK Sample Size: 60
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment01/11/2012
Date of final enrolment01/07/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Oxford
Oxford
OX3 7JX
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

Nuffield Department
Obstetrics and Gynaecology
Division of Medical Sciences
Oxford
OX3 9DU
England
United Kingdom

Website http://www.ox.ac.uk/
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 11/07/2013 Yes No
Results article results 01/11/2015 Yes No