Evaluating the OBtAIN-PD feasibility randomised controlled trial
Research type
Research Study
Full title
Evaluating the Occupation-Based Complex Intervention for living well with anxiety and Parkinson’s Disease (OBtAIN-PD): a feasibility cluster randomised controlled trial
IRAS ID
318175
Contact name
Chris Lovegrove
Contact email
Sponsor organisation
University of Plymouth
ISRCTN Number
ISRCTN62762494
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
Anxiety is experienced by 56% of people with Parkinson’s and is a research priority for Parkinson’s UK, a national charity. 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. We have developed, 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 is based on Occupational Therapy principles that emphasise the importance that active engagement in meaningful activities has in determining people’s well-being and self-esteem.
The intervention, called OBtAIN-PD, 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 conduct a feasibility trial to determine whether conducting a clinical trial evaluating the intervention is realistic. The trial will involve people with Parkinson’s and anxiety receiving either OBtAIN-PD or usual care from their community rehabilitation teams. These teams will be randomised to give OBtAIN-PD or usual care only.
Essential care-related activities will occur in both groups. 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 the 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 usual care on a larger scale. This would help to show how effective the intervention is.
REC name
North East - York Research Ethics Committee
REC reference
23/NE/0027
Date of REC Opinion
2 Mar 2023
REC opinion
Further Information Favourable Opinion