Parkinson's disease Mental and Behavioural Disorders
Conditions
Interventions
This is a pragmatic feasibility cluster randomised controlled trial, with assessor-blinded outcome assessment, cluster randomising Community Rehabilitation Teams within two sites to implement either t
two of the four CRTs will be allocated to the intervention group (OBtAIN-PD plus standard care), and two will be allocated to the usual care group (standard care alone).
GROUP ALLOCATION
Community
Sponsors
University of Plymouth
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must satisfy all the following criteria to be enrolled in the study: 1. PWPs: diagnosis of idiopathic Parkinson’s (47), as diagnosed by a neurologist or movement disorder consultant 2. Experiences anxiety measured as ‘moderate’ (> = 10) by the Generalised Anxiety Disorder Assessment (GAD-7) as part of the screening process 3. Willing and able to undertake eight intervention sessions over 10 weeks 4. Able to give informed consent
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study participation: 1. Participants unable to give informed consent 2. People who are unable to physically complete self-report forms and do not have someone to assist them 3. PWPs experiencing anxiety measured as ‘mild’ (9 or less) by the generalised Anxiety Disorder Assessment (GAD-7) 4. PWPs with a severe cognitive deficit that affects their ability to follow instructions assessed using the Montreal Cognitive Assessment (< 23) (48) 5. ‘End-of-life stage’ Parkinson’s or other potentially life-limiting condition which is likely to be the main source for anxiety e.g., cancer, heart failure, advanced lung disease 6. PWPs currently participating in a research study testing an intervention for anxiety or receiving another clinician-delivered non-pharmacological intervention for anxiety that has started within the last six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-perception of performance in everyday living measured using the Canadian Occupational Performance Measure (COPM) at baseline, 12 weeks, and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Activity participation and activity changes are measured by the Activity Card Sort at baseline, 12 weeks, and 24 weeks 2. Patient-reported outcome measures are captured at baseline, 12 weeks, and 24 weeks and include: 2.1. Anxiety symptoms measured using the GAD-7 2.2. Parkinson's-related health status and quality of life measured using the PDQ-39 2.3. Health-related quality of life measured using the EuroQol EQ-5D-5L 2.4. Falls measured using self-reporting and the resource use log | — |
Countries
England, United Kingdom
Contacts
Public ContactWendy Ingram
Outcome results
None listed