Testing the combination of Feeling Safe and peer counselling against formulation-based cognitive behaviour therapy to promote psychological wellbeing in people with persecutory delusions: study protocol for a randomized controlled trial (the Feeling Safe-NL Trial).

BACKGROUND: Persecutory delusions are strong threat beliefs about others' negative intentions. They can have a major impact on patients' day-to-day life. The Feeling Safe Programme is a new translational cognitive-behaviour therapy that helps patients modify threat beliefs and relearn safety by targeting key psychological causal factors. A different intervention approach, with growing international interest, is peer counselling to facilitate personal recovery. Combining these two approaches is a potential avenue to maximize patient outcomes. This combination of two different treatments will be tested as the Feeling Safe-NL Programme, which aims to promote psychological wellbeing. We will test whether Feeling Safe-NL is more effective and more cost-effective in improving mental wellbeing and reducing persecutory delusions than the current guideline intervention of formulation-based CBT for psychosis (CBTp). METHODS: A single-blind parallel-group randomized controlled trial for 190 out-patients who experience persecutory delusions and low mental wellbeing. Patients will be randomized (1:1) to Feeling Safe-NL (Feeling Safe and peer counselling) or to formulation-based CBTp, both provided over a period of 6 months. Participants in both conditions are offered the possibility to self-monitor their recovery process. Blinded assessments will be conducted at 0, 6 (post-treatment), 12, and 18 months. The primary outcome is mental wellbeing. The overall effect over time (baseline to 18-month follow-up) and the effects at each timepoint will be determined. Secondary outcomes include the severity of the persecutory delusion, general paranoid ideation, patient-chosen therapy outcomes, and activity. Service use data and quality of life data will be collected for the health-economic evaluation. DISCUSSION: The Feeling Safe-NL Trial is the first to evaluate a treatment for people with persecutory delusions, while using mental wellbeing as the primary outcome. It will also provide the first evaluation of the combination of a peer counselling intervention and a CBT-based program for recovery from persecutory delusions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN25766661 (retrospectively registered 7 July 2022).

Supporting survivors of sexual violence: protocol for a mixed-methods, co-research study of the role, funding and commissioning of specialist services provided by the voluntary sector in England.

INTRODUCTION: The voluntary sector provides a range of specialist services to survivors of sexual violence, many of which have evolved from grass roots organisations responding to unmet local needs. However, the evidence base is poor in terms of what services are provided to which groups of survivors, how voluntary sector specialist (VSS) services are organised and delivered and how they are commissioned. This will be the first national study on the role of the voluntary sector in supporting survivors in England. METHODS AND ANALYSIS: This study uses an explanatory sequential naturalistic mixed-methods design with two stages. For stage 1, two national surveys of providers' and commissioners' views on designing and delivering VSS services will facilitate detailed mapping of service provision and commissioning in order to create a taxonomy of VSS services. Variations in the national picture will then be explored in stage 2 through four in-depth, qualitative case studies using the critical incident technique to explain the observed variations and understand the key contextual factors which influence service provision. Drawing on theory about the distinctive service contribution of the voluntary sector, survivors will be involved as co-researchers and will play a central role in data collection and interpretation. ETHICS AND DISSEMINATION: Ethical approval has been granted by the University of Birmingham research ethics committee for stage 1 of the project. In line with the sequential and co-produced study design, further applications for ethical review will be made in due course. Dissemination activities will include case study and end-of-project workshops; good practice guides; a policy briefing; project report; bitesize findings; webinars; academic articles and conference presentations. The project will generate evidence about what survivors want from and value about services and new understanding about how VSS services should be commissioned and provided to support survivors to thrive in the long term.