Better Sleep Trial
| ISRCTN | ISRCTN33695128 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33695128 |
| Protocol serial number | 12766 |
| Sponsor | University of Oxford (UK) |
| Funder | NIHR Research for Patient Benefit Programme ref: PB-PG-0211-10007 (UK) |
- 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
Scientific
University Department of Psychiatry
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
| Daniel.Freeman@psych.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Better Sleep Trial: a pilot randomised controlled trial for patients with delusions and/or hallucinations |
| Study objectives | 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(s) | First MREC, 23/04/2012, ref: 12/SC/0138 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Insomnia Severity Index measured at 0,12, and 24 weeks |
| Key secondary outcome measure(s) |
Psychotic Symptoms Rating Scale measured at 0,12, 24 weeks |
| Completion date | 01/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/11/2012 |
| Date of final enrolment | 01/07/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Oxford
Oxford
OX3 7JX
United Kingdom
OX3 7JX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2015 | Yes | No | |
| Protocol article | protocol | 11/07/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
