Title: Development and feasibility testing of a brief behavioural intervention to improve sleep in people with schizophrenia spectrum disorders.
Funder: Health Education England

Abstract: Background: Sleep problems are very common in people with schizophrenia spectrum disorders, and have been linked to worse symptoms and poorer functioning, however there is a lack of evidence based guidance for the management of sleep problems in this population.Cognitive Behavioural Therapy for Insomnia (CBT-i) is an effective treatment in other populations, and early indications suggest that a tailored form of CBT-i can improve sleep in people with current delusions and hallucinations. Availability of CBT-i remains poor however, including in populations for whom it has well established efficacy, and experts call for development of briefer interventions. Compared to other groups, people with schizophrenia spectrum disorders often experience more problems with circadian rhythm, increased night-time activity, reduced daytime activity, and poor sleep maintenance. Research shows that circadian rhythms are entrained by exposure to environmental and behavioural cues, particularly light exposure. To enhance circadian entrainment attention should be paid to the nature and timing of environmental and behavioural cues within a person's routine. Furthermore patients themselves emphasise the importance of a whole lifestyle' approach, for improving night-time sleep. Input regarding daytime activity is not a core component of CBT-i or its variants. It is proposed that input regarding daytime activity should be incorporated, within a brief behavioural treatment for poor sleep in people with schizophrenia spectrum disorders. Because occupational therapists specialise in addressing daytime activity they would be well placed to deliver this intervention, although they often currently have limited involvement in addressing poor sleep. Aims: 1) To develop an acceptable, safe and user-centred behavioural treatment for poor sleep in schizophrenia spectrum diagnoses, incorporating input regarding daytime activity, delivered by an occupational therapist.2) To assess acceptability, and feasibility of implementation and testing in secondary care mental health settings. Methods: Phase 1: Literature review Through systematic searching and screening all studies evaluating CBT-i or other behavioural treatments for poor sleep in people with serious mental illness will be identified. Treatment protocols will be sourced, and any guidance of mention of daytime activity will be analysed using Thematic Synthesis. An iterative stage will follow where further relevant literature will be purposively sampled and integrated. Phase 2: Delphi study to develop an adapted brief behavioural intervention for sleep problems. Eighty-five relevant experts and stakeholders will be recruited (including mental health occupational therapists, sleep experts, managers, patients and carers). Expert perspectives will be sought in a series of rounds, culminating in rating of ideas to reach a consensus on the intervention to be delivered. Phase 3: Mixed methods feasibility study evaluating acceptability of the intervention, and feasibility of larger scale testing. A single group study recruiting twenty participants will be conducted. Data regarding expectations, priorities, acceptability and barriers to adherence will be gathered through semi-structured interviews by trained service user researchers before and after intervention, and analysed using Framework Analysis. Recruitment rates, attrition, adherence to the intervention, and appropriateness of study specific measures will be evaluated. Deliverables: Results will inform further development or further testing of the intervention. Qualitative data and experiential learning will also support the development of a short training package to enable mental health occupational therapists to deliver this intervention. In the mid-term it is the aim for this line of research to lead to the widespread availability of an effective, non-pharmacological, first line treatment for sleep problems in this population.

Lay abstract: Background and aims: Sleep problems are very common in people with schizophrenia and related disorders (including schizoaffective disorder and delusional disorder). We know from research that when people with schizophrenia have sleep problems this impacts negatively on their quality of life, affects their recovery, can affect their social life or work, and worsens isolation.There is limited evidence about sleep treatment in schizophrenia. In other groups drug based treatment of sleep problems can work short-term, but drugs are less effective long-term, and can have unwanted side effects. Cognitive behavioural therapy for insomnia (CBT-i) has been found to be effective in the longer term, but CBT-i is not widely available in practice. Experts have called for briefer alternatives to CBT-i to be created, to improve availability. Research suggests people with schizophrenia have different types of sleep problems than people with other conditions, including more irregular, broken and un-refreshing sleep, often combined with being less active in the daytime. Theories of sleep processes suggest addressing daytime activity may improve sleep quality, by increasing tiredness at bedtime, and by improving sleep rhythms (circadian rhythms). We plan to develop a brief alternative to CBT-i, adding input about daytime activity, delivered by an occupational therapist. Methods and design: First I will systematically search for and read the treatment instructions from all previous CBT-i studies in people with serious mental illness (including brief CBT-i alternatives). Input on daytime activity is not a core component of CBT-i, but I will summarise any instructions that were given for addressing daytime activity, and then bring in other relevant literature. Next we will develop and refine the treatment, drawing on the knowledge of eighty-five experts of various types (clinicians, researchers, patients and carers). Experts will be consulted in four rounds', beginning with focus group discussions, and ending with voting on ideas. By the end we will have refined the design of the treatment (this method is called a Delphi study). Finally, we will try the treatment we have developed, with twenty participants, in a feasibility study. This study will tell us whether it is possible to deliver the treatment, whether the treatment is acceptable to service users and whether service users are able to follow the treatment recommendations. We will take measurements which would be useful in a larger trial, checking for any problems with gathering the data, and checking what participants think about completing the measures. We will gather information about how well we manage to recruit participants, and whether people drop out of the study. This would help us to plan a larger trial in future, to test whether the treatment is effective.Patient and public involvement: To involve patients in the study we will appoint a patient advisory group, who we will consult on various questions, at various stages. For instance we will ask the patient advisory group to help design the recruitment materials for the feasibility study. We will ask the patient advisory group what outcomes of treatment would be important for them, to help decide what questionnaires and measures we need to use. Whilst we are designing the intervention, we will ask the patient advisory group to help analyse what the expert focus groups have said. The patient advisory group will also help design the questions asked of the experts. This will mean that patients have input at each stage as the intervention is developed. We want to gather interview data from people who have the treatment, and we plan to employ service user researchers to gather and analyse this feedback. Publishing the findings: We plan to publish the findings through peer-reviewed academic journals, making full use of the options many journals now offer for open access' (free to read) publishing, and options to attach videos, or audio-visual material to support the articles. We plan to present the findings at professional and academic conferences, to service user groups, and to NHS organisations. We will also write shorter pieces, in an accessible format for mainstream online and printed outlets, aimed at service users, professionals and the public. If the study is successful, that is - if the feasibility study suggests that a larger study would be worth running, then a larger study will be planned, and more therapists would be trained to deliver this intervention. The aim is that this research would eventually lead to the widespread availability of a brief non-drug treatment, which could be delivered with limited additional staff time or training, by existing community mental health services.

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