Testing the feasibility of a new intervention to help people with Parkinson's live well with anxiety

Not Applicable

Completed

Conditions: Parkinson's disease
Mental and Behavioural Disorders

Registration Number: ISRCTN62762494

Lead Sponsor: niversity of Plymouth

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 11

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-perception of performance in everyday living measured using the Canadian Occupational Performance Measure (COPM) at baseline, 12 weeks, and 24 weeks

Secondary Outcome Measures

Name	Time	Method
1. Activity participation and activity changes are measured by the Activity Card Sort at baseline, 12 weeks, and 24 weeks<br>2. Patient-reported outcome measures are captured at baseline, 12 weeks, and 24 weeks and include:<br>2.1. Anxiety symptoms measured using the GAD-7<br>2.2. Parkinson's-related health status and quality of life measured using the PDQ-39<br>2.3. Health-related quality of life measured using the EuroQol EQ-5D-5L<br>2.4. Falls measured using self-reporting and the resource use log