Title: Treating insomnia in patients with delusions and hallucinations: a pilot randomised controlled trial.
Funder: Department of Health (England)

Abstract: This research is about the treatment of significant mental health problems Insomnia is defined as having chronic difficulties getting or staying asleep. These problems are common in patients who have delusions (e.g. falsely believing everyone is trying to harm them) and hallucinations (e.g. ‘hearing voices’), which are difficult to treat severe mental health problems Importantly, insomnia is one factor that triggers delusions and hallucinations, and makes the experiences much more distressing when they do occur. As we all know, things are simply worse when we haven’t been sleeping. The clinical implication is that if the insomnia is treated then the delusions and hallucinations will also reduce. There are highly effective psychological treatments for insomnia but they have not been evaluated in patients with psychosis. The only evaluation has been our initial case series treating 15 patients with Cognitive Behavioural Therapy for Insomnia (CBT-I), which was so successful that we have submitted this application. It was very popular with the patients, with comments such as: “It has helped me feel clear in my mind. I am now less concerned about other people, feel more content, feel good, more active, getting on with things and less worried about the past.” “It has helped me sleep more so I don’t get so low, have fewer worries about others and less anxiety.” “I am now more relaxed, I am able to get back to sleep when I wake up and know there are ways to defeat insomnia.” We aim to show not only that insomnia can be treated in patients with psychosis, but that it leads to significant benefits in reducing the distressing delusions and hallucinations. We will use the best method of testing a treatment, comparing people who have the CBT-I treatment with people who do not have the treatment, using an assessor who does not know who has had the treatment. This is a pilot trial, before a definitive RCT with a greater number of participants, and will provide an excellent test of our trial procedures. It will provide an estimate of treatment effect sizes for the Phase III trial. 60 patients with a schizophrenia or related diagnosis will take part, and be randomised to CBT-I in addition to standard care or to standard care (the control condition). All patients will have distressing delusions and/or hallucinations, and report problems sleeping. Assessments will be carried out before randomisation (0 weeks), after treatment (12 weeks), and at follow-up (24 weeks). They will comprise state of the art assessments of sleep, delusions and hallucinations. We will be able to test for the first time the use of actigraphy and sleep diaries in this specific population. We will also monitor the potential cost-effectiveness of the intervention. The main trial analysis will be based on the intention-to-treat principle, with due consideration being given to potential biases arising from loss to follow-up. The research group comprises clinical psychologists, a psychiatrist, a consultant neurophysiologist, a health economist, and a statistician, with extensive experience of psychosis, sleep disorders, sleep interventions, and clinical trials. We are the only research group in the world carrying out this work. We will link with a mental health clinical trials unit and follow best practice in running and reporting the trial. The sleep techniques that we use have the potential to be easily taught to other mental health professionals and therefore used widely in the NHS if demonstrated to be clinically beneficial for this group.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH