Evaluating the occupation-based complex intervention for living well with anxiety and Parkinson's disease (OBtAIN-PD) in community rehabilitation teams in the UK: a feasibility cluster randomised controlled trial protocol

Abstract

Introduction: Anxiety is a common non-motor symptom of Parkinson's that is associated with reduced life quality, independence and health outcomes. Current anxiolytic medications and the most promising behavioural interventions have inconclusive and mixed results. Occupational therapy is effective at promoting participation in activities of daily living and is recommended in national guidelines. This cluster randomised controlled trial aims to test the feasibility and fidelity of a new occupation-based complex intervention for living well with anxiety in Parkinson's disease (OBtAIN-PD). No such evidence-based intervention currently exists.

Methods and analysis: 50 people with Parkinson's will be recruited from Devon, UK, to undertake the OBtAIN-PD or usual care delivered by community-based occupational therapists across two National Health Service sites. Recruitment, attrition rates and feasibility of proposed outcome measures (Canadian Occupational Performance Measure, Generalised Anxiety Disorder-7, The Parkinson's Disease Questionnaire-39, Activity Card Sort, Barthel Index and fall logs) will be tested. Resource data will be collected to aid in the feasibility assessment. Fidelity to content will be assessed using process evaluation. Subjective experiences will be explored qualitatively (10 participants, occupational therapists and decliners).

Ethics and dissemination: This trial has been registered with the ISRCTN registry. Ethical approval has been obtained from the North East - York Research Ethics Committee (reference 23/NE/0027) before data collection. Participants will receive a summary of the results at the end of the data analysis. We will publish the results in a peer-reviewed journal and on institution websites.

Trial registration number: ISRCTN62762494.

Keywords: Feasibility Studies; MENTAL HEALTH; Parkinson-s disease; Randomized Controlled Trial.

Figure 1. The OBtAIN-PD feasibility study questions. OBtAIN-PD, occupation-based complex intervention for living well with anxiety in Parkinson’s disease.

Figure 2. The OBtAIN-PD feasibility cluster randomised controlled trial in relation to the Medical Research Council framework. Adapted from Skivington et al. OBtAIN-PD, occupation-based complex intervention for living well with anxiety in Parkinson’s disease.