Title: Developing the evidence base to improve implementation and uptake of CBTp: A feasibility study adopting service user and clinician perspectives to shape a brief pre-CBTp interactive ‘informed choice’ intervention in the South East and London for patient benefit
Funder: Department of Health and Social Care

Abstract: Background: Psychosis is a distressing and debilitating condition which affects 1-2% of the population in the UK. It has a high recurrence rate despite optimal medication treatment. Symptoms persist in 40% (approximately 240,000 service-users). Apart from the significant distress to patients, they make use of considerable NHS inpatient and community resources and the cost has been estimated at 6.7 Billion. CBTp is the only recommended individual therapy that reduces distressing symptoms, improves quality of life and is cost-effective but fewer than 20% of patients receive it and 94% of NHS trusts struggle to deliver it. CBTp implementation is a national and a local priority, but barriers are complex and multi-faceted. Personal barriers exist, such as lack of knowledge about CBTp, pessimism regarding outcomes and effectiveness, unhelpful health and treatment beliefs, but, little is known about these personal barriers or their impact on uptake/implementation. Aim: This study will develop and test the feasibility of two new pre-CBT informed choice interventions that aim to help inform decisions to offer (clinicians) and accept (service-users) CBTp, by impacting on hope, self-efficacy and empowerment and by addressing personal barriers (knowledge and beliefs). Research question: Can the informed choice interventions be feasibly implemented in the NHS to improve knowledge, beliefs and behaviours of clinicians and service-users to CBTp implementation and uptake? Plan of Investigation: Phase 1 - Four focus groups in each site (London and Sussex): (i) clinicians who are supportive of/have offered CBTp; (ii) clinicians who are not supportive of/have not offered CBTp; (iii) psychosis service-users who would like/have accepted CBTp; and (iv) psychosis service-users who do not want/have not accepted CBTp, will explore personal barriers and facilitators (e.g. knowledge, beliefs and behaviours) towards CBTp. Analysis will identify important themes which will be used to form an online questionnaire. The questionnaire will be completed by 200 clinicians and 200 service-users from psychosis services in Sussex and London. The results of the questionnaires will be used to draft the informed-choice interventions. Phase 2 - Two pre-CBTp informed-choice interventions, one for service-users and one for clinicians, will be developed using a consultation (Delphi) process with clinicians, service-users and other stakeholders, based on knowledge of health perceptions, motivational theory, implementation science and information obtained from Phase 1. The final interventions will be confirmed through consensus but are likely to explore (i) knowledge (ii) experiences (iii) motivation (iv) health perceptions, and (v) decision making delivered through interactive website materials or booklets. Phase 3 &ndash; Feasibility will be assessed in two small-scale RCT s with clinicians (n=20 vs. 20) and service users (n=20 vs. 20) who are ambivalent or negative regarding CBTp, in Sussex and London. Participants will complete outcome measures before and after the intervention and at 3 month follow-up. A mixed quantitative and qualitative methodology will be used to investigate recruitment success, engagement with and use of the intervention, follow up rates and preliminary estimates of effect sizes. Potential Benefits: The study will provide novel information on the personal barriers and facilitators (knowledge and beliefs) that affect uptake and implementation of psychologial interventions in general and CBTp in particular. Two novel outcome measures and two novel informed choice interventions will be produced with the potential to impact directly on informed and empowered decisions about uptake and implementation of CBTp by staff and service-users, and to impact more broadly on service-user mental health and well being (hope, self-efficacy, empowerment). The questionnaires will be available before the end of this project, enabling clinicians and service-users to explore their stance towards CBTp. A proposal will be prepared alongside the final phase of the project to enable swift transition to a multi-centre RCT.

Lay abstract: Psychosis affects over 600,000 people in the UK many of whom have recurring persistent symptoms, despite medication. Symptoms include beliefs that people are conspiring against you and want to harm you (persecutory delusions) or hearing voices that are critical, abusive or command you to do unpleasant, harmful things (auditory hallucinations). The distress caused and the impact on day-to-day function leads to hospitalisation and poor quality of life. Currently, CBTp is the only recommended individual talking therapy. It can help people manage these distressing experiences by changing the way they think and behave, leading to improved recovery and quality of life. However 94% of trusts struggle to deliver it and fewer than 20% of patients receive it because of barriers like lack of knowledge about what CBTp is and does, strong medical beliefs and associated pessimism about whether CBTp works, and lack of hope and confidence in the ability to cope and change. This study aims (i) To understand more about the knowledge, beliefs and behaviours of clinicians and service-users towards CBTp (ii) To develop questionnaires to assess these personal barriers and facilitators (iii) To develop brief, pre-CBT interactive, decision aids, ('informed choice' interventions which explore and address these barriers, providing information, video experience, exploration of motivation and health beliefs to facilitate hope, empowerment and informed decision-making. (iv) To assess in detail the feasibility of using these interventions in the NHS and their likely benefit. It is anticipated that Clinicians and service-users will be more informed and empowered and that (i) the questionnaires will raise awareness regarding personal barriers towards CBTp, which may in itself lead to behaviour change (ii) the interventions can be feasibly implemented and (iii) that preliminary data will demonstrate direct effects on well-being, quality of life, personal stance towards CBTp, uptake and implementation o CBTp. .

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH