Title: Developing an occupation-based complex intervention for living well with anxiety in Parkinson's (OBtAIN-PD)
Funder: Health Education England

Abstract: Background: Parkinson's is the second most common neurodegenerative condition in the UK affecting approximately 127,000 people. The condition's cardinal symptoms are tremor, bradykinesia, and loss of automatic movement. Up to 56% of people with Parkinson's experience anxiety. Parkinson's-related anxiety is linked to the condition's pathology. Anxiety in Parkinson's is associated with reduced life quality, independence, and health outcomes. This results in an increased financial burden for the person, their families, and the care system. Current anxiolytic medications are ineffective at treating anxiety in Parkinson's. The most promising behavioural interventions (e.g. mindfulness) have inconclusive and mixed results. Occupational therapy is effective at promoting participation in activities of daily living and is recommended in national guidelines. An evidence-based occupational therapy intervention for living well with anxiety in Parkinson's does not exist. This study will build upon the applicant's previous research. Logic modelling will be used to design a new occupation-based complex intervention for anxiety co-produced with people with Parkinson's from seldom-heard group, carers, and occupational therapists. The intervention will undergo feasibility and fidelity testing. Logic modelling aim: To design a new occupation-based complex intervention for living with anxiety in Parkinson's in co-production with people with Parkinson's, their carers, and occupational therapists, and integrating evidence from a systematic review completed before the fellowship period. Feasibility study aim: To establish the new intervention's feasibility and fidelity. Methods: People with Parkinson's, carers, and occupational therapists will be recruited (n=40) to participate in logic modelling via purposeful and snowball sampling to reach a consensus on the intervention design. This consensus will be integrated with previous qualitative findings and current evidence to develop the intervention. This will be tested in a feasibility randomised controlled trial. Fifty people with Parkinson's will berecruited from Devon to undertake the intervention delivered by four community-based occupational therapists across two sites. Recruitment, attrition rates, and the feasibility of proposed outcome measures (COPM, GAD-7, PDQ-39, Activity Card Sort, Barthel Index, fall logs) will be tested. Resource data will be collected to aid in the feasibility assessment. Fidelity will be assessed using process evaluation. Subjective experiences of theintervention will be explored qualitatively (10 participants, two clinicians, and those declining to participate). Outcomes: This study will lead to a refined intervention and a multi-centre randomised controlled trial to evaluate the intervention's clinical and cost-effectiveness. This study will contribute to the development of future clinical guidelines and the implementation of new practice within the National Health Service.

Lay abstract: Anxiety is experienced by 56% of people with Parkinson's and is a research priority for Parkinson's UK, a national charity. Anxiety can be caused by the disease process in the brain in Parkinson's as well as by people's response to the stress from living with the disease. Our previous research has suggested that anxiety in Parkinson's is a complex experience that reduces people's feelings of self-control. Anxiety can mean that people with Parkinson's may go out less, engage less with activities, and feel like they are not in control of their lives. These things add to a lower quality of life for people with Parkinson's living with anxiety.For people who do not have Parkinson's, anxiety can be managed with talking therapies like cognitive behavioural therapy and medications. In Parkinson's currently available treatments for anxiety do not work very well. This may be because the thoughts, feelings, and impact associated with anxiety in Parkinson's have not been considered when developing and delivering the treatments. This fellowship will develop, in collaboration with people with Parkinson's, carers, and healthcare professionals, a new intervention to help people with Parkinson's live well with anxiety. The intervention will be based on Occupational Therapy principles that emphasise the importance that active engagement in meaningful activities have in determining people's well-being and self-esteem.To develop the new intervention we will work with a group of people with Parkinson's, their carers, and a group of clinicians. We will talk to a range of people so that we are not getting information from just one group of people. The intervention development will use a technique called logic modelling. It will involve structured discussions that will be based on information gathered from our previous research, the findings of a comprehensive review of previous research studies in this area, and our extensive discussions with people with Parkinson's and carers. We will ensure that people with Parkinson's, their carer's, and clinicians find the new intervention acceptable and practical. The developed intervention will be summarised in a training package for Occupational Therapists. It is expected to last 10-weeks and focus on activities that are meaningful to the person with Parkinson's facilitated by an Occupational Therapist.We will then determine whether it is feasible to conduct a clinical trial evaluating the intervention. The trial will involve people Parkinson's and anxiety being randomly allocated to the new intervention or to usual care. Essential care-related activities will occur in both groups. In this testing stage, we will check the rate people are recruited into the trial and factors such as the presence of any adverse events and the number of outcome measures obtained. We will also determine that Occupational Therapists are able to deliver the intervention accurately. This data will be supported by interviews with participants and therapists about their experience of the trial and intervention. If this project is successful, we want to run a bigger research study to test the new intervention against a current treatment on a larger scale. This would help to show how effective the intervention is.Our previous research and discussions with people with Parkinson's have shown that anxiety research is important to them. People have highlighted how anxiety was 'always there' and 'stops me doing things'. Others reported feeling 'helpless' despite being offered help from professionals. They told us that the aims of this research project were important and it would be helpful research for people with Parkinson to help them live well with anxiety. The views of people with Parkinson's have informed the project design and will continue to guide the project, its dissemination, and future development.

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