Parkinson Disease(PD)
Conditions
Keywords
Empathy, (self-)compassion, Parkinson disease (PD)
Brief summary
The goal of this clinical trial is to improve quality of life in Parkinson's Disease (PD) patients by increasing their empathy and their (self-)compassion. The main question it aims to answer is: Does the level of quality of life in PD patients and caregivers improve after empathy/(self-)compassion training? Participants will be delivered a 6-week empathy and compassion training (mindfulness, writing and poetry exercises addressing the cognitive, emotional, motivational and behavioural components of (self-)compassion) and will also be asked to answer questionnaires before and after the training
Interventions
BEHAVIORALempathy and compassion training
A 6-week empathy and compassion training will be designed and delivered involving PD patients and caregivers. During the compassion training participants will do mindfulness, writing and poetry exercises
Sponsors
CTU-EOC Clinical Trial Unit Ente Ospedaliero Cantonale
Alain Kaelin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of PD * Hoehn and Yahr scale, stage ≤ 3 * Mini Mental State Examination with a score ≥ 26 * Able to give informed consent as documented by signature * At least, secondary school education * To have a regular caregiver at home
Exclusion criteria
* Any medical condition that is not PD, such as drug induced parkinsonism * Major depression, dysthymia, or according to DSM-V * Other neurological or psychiatric diseases * Neuropsychological scores compatible with the diagnosis of early dementia * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc For CAREGIVERS: Inclusion criteria * Taking care of the patient on a regular basis, i.e., at least 3 days per week * Being caregiver of the patients for at least 3 months * At least, secondary school education * Written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PD patients quality of life improvement | from baseline to the end of intervention (6weeks) | the change (no min / max values foreseen) in the level of quality of life in PD patients as measured by the Parkinson's Disease Questionnaire (PDQ-8), which assesses 8 domains of quality of life: mobility, activities of daily of living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort; higher scores indicate a worse quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in the level of empathy in PD patients and caregivers | from baseline to the end of intervention (6weeks) | change in the level of empathy in PD patients and caregivers as measured by Interpersonal Reactivity Index (IRI): this questionnaire captures both the cognitive and emotional facets of empathy. It includes four seven-item subscales: 1) Fantasy (F) and 2) Perspective Taking (PT) for the cognitive dimension and 3) Empathic Concern (EC) and 4) Personal Distress (PersDis) for an emotional one. The F scale assesses the tendency to identify oneself imaginatively in characters and situations (for example, movie characters and novels); the PT scale contains elements that map to the ability to apply the perspectives of other people from their point of view; the EC scale evaluates feelings of compassion and concern regarding other people; the PersDis measures the personal feelings of anxiety and discomfort that are experienced by observing the negative emotion |
| self-compassion level change in PD patients and caregivers | from baseline to the end of intervention (6weeks) | change in the level of self-compassion in PD patients and caregivers as measured by Self-Compassion Scale (SCS): this is a 26-item validated questionnaire which measures self-compassion with six subscales: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Past studies used this test with people with Parkinson's . The total self-compassion score is the mean of the six subscale means and ranges from 1 to 5, with a higher score indicating greater self-compassion |
| compassion level change in PD patients and caregivers | from baseline to the end of intervention (6weeks) | change in the level of compassion in PD patients and caregivers as a derived measure of the SCS: a 26-item validated questionnaire, measures self-compassion with six subscales: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Past studies used this test with people with Parkinson's. The total self-compassion score is the mean of the six subscale means and ranges from 1 to 5, with a higher score indicating greater self-compassion |
| quality of life level change in caregivers | from baseline to the end of intervention (6weeks) | change in the level of quality of life in caregivers as measured by the Family Caregiver Quality of Life Scale (FAMQOL): it evaluates caregivers' quality of life across multiple dimensions (physical, psychological, and social well-being). The FAMQOL consists of 16 self-reported questions with 5-option Likert responses, ranging from Strongly Disagree to Strongly Agree |
Countries
Switzerland
Contacts
Primary ContactAlain Kaelin, Prof. MD PhD
Outcome results
None listed