Title: A development and feasibility study for an RCT of nature-based social prescribing for mental health
Funder: Department of Health and Social Care

Abstract: Research Question To gather information needed to develop research for clinically relevant, robust evidence on the effectiveness of therapeutic nature interventions on mental health outcomes. Background Common mental health conditions, such as depression, anxiety, and stress, affect up to 15% of the UK population at any time, and one in four people experience a mental health problem at some point in their lives. There is increasing interest in providing personalised care for people with mental ill health, including facilitating access to community-based sources of support. Social prescribing (SP) links people to social or community-based resources &ndash; including nature-based activities - which have the potential to improve health and wellbeing. While there are numerous organisations providing nature-based activities, there are few studies using the most reliable methods to assess their effectiveness for people with mental ill-health. Aims and objectives We propose an approach to further develop and refine a feasible and acceptable nature-based social prescribing (NBSP) intervention, and assess the feasibility of undertaking the first fully powered randomised controlled clinical trial into its effectiveness and cost-effectiveness for the treatment of common mental health conditions. We will work closely with two NBSP partners &ndash; the Wildfowl and Wetlands Trust (WWT) and Newquay Orchard and build on previous and current work in NBSP which included the development of an evidence based Handbook for NBSP, proposing mechanisms of action, which can be adapted to local contexts, and which are likely to support mental health. Our aims are: To identify feasible and acceptable NBSP intervention components and appropriate delivery system characteristics from the perspectives of NBSP stakeholders. To finalise the target population, comparator group(s), and outcomes to be assessed for the future randomised controlled clinical trial (Stage 2). To understand the costs of delivering NBSP. To identify the key study design elements, including health economics, for the Stage 2 RCT. To develop a research plan and funding proposal for the Stage 2 clinical trial. To agree the feasibility and acceptability of the proposed research plan for NBSP stakeholders, including publics/patients/carers. Methods Intervention and research uncertainties will be explored using a combination of methods in order to finalise a feasible and appropriate trial design: consultations, interviews and workshops with partner NBSP providers (WWT and Newquay Orchard), GPs, Link Workers and potential NBSP provers for the future trials; embedded researcher visits at the partner NBSP activities; targeted evidence reviews of key trial features; refinement of a Theory of Change. A bespoke PPI group will be convened and online and in person workshops held to understand the public perspective on specific trial proposals. We will also conduct a feasibility study of 70 people to assess key methodological aspect of the proposed future trial such as participation and adherence to the NBSP intervention and ability to collect appropriate data. Timeline 7 months Anticipated Impact and Dissemination The key study output will be a fully designed research proposal for a trial to investigate the effectiveness of nature-based social prescribing to address mental health need for which we will seek funding.

Lay abstract: This project aims to develop and test a research plan for a future full randomised controlled trial (RCT) of nature-based social prescribing to support people with mental ill-health. Social prescribing, which is increasingly used in the UK, involves GPs referring people living with mental ill-health to community activities as part of their treatment. Frequently Link Workers help patients identify activities that may suit them. They might choose: community choirs; volunteering opportunities; physical activity; or nature-based activities. There are a large number of nature-based social prescribing projects, yet few have been evaluated using robust methods. Healthcare commissioners and staff are increasingly seeking high quality evidence of the clinical effectiveness of nature-based social interventions to guide them in the best allocation of resources. RCTs are widely accepted as the most reliable way to demonstrate effectiveness. This type of evaluation will support more confident decision making and help ensure that people with mental health needs are referred to the most appropriate interventions for them. Nature-based social prescribing is what is known as a complex intervention. It uses several stages of consultation and referral to allocate people to interventions, each of which may involve different types of activities, taking place in different localities, organised and led in different ways. Before undertaking a full trial, it is important to ensure the plans for that research are feasible, appropriate and acceptable, so that the outcomes of the RCT will be meaningful. The research team are experienced in evaluating nature based social prescribing. The team also has expertise in: complex interventions; RCTs; connections between the environment and health; Patient and Public Involvement; health economics; and statistics. We will work together to design a research plan which will include: defining the target population, determining the most appropriate measurable outcomes and identifying a comparison group. In doing this we will consult with people already involved in social prescribing including: GPs, Link Workers, and nature-based activity providers. By advertising the study through these partners, we will recruit some of their service users to assess whether our plans will be acceptable to participants in the future RCT. We will test the plan with a small number of GPs, nature-based activity providers and their participants to make sure it is appropriate and feasible. This will ensure that the processes are sound and achievable, that we are able to recruit enough people to the study, and that questionnaires used to measure impact are appropriate. The outcome of the study will be a fully designed protocol, a detailed plan, for a future RCT which will assess the effectiveness of nature-based social prescribing for people with mental ill-health.

Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH