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| Name | Class |
|---|---|
| CTU-EOC Clinical Trial Unit Ente Ospedaliero Cantonale | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empathy and (self-)compassion training | Experimental | 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 addressing the cognitive, emotional, motivational and behavioural components of (self-)compassion. The training will be designed in order to address both self-compassion and compassion. We expect to conduct 1 session at the beginning and 1 session at the end of the program with exercises to do at home for 6 weeks, assigned as tasks based on the needs of patients and their caregivers |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| empathy and compassion training | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PD patients quality of life improvement | 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 | from baseline to the end of intervention (6weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| change in the level of empathy in PD patients and caregivers | 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 |
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Inclusion Criteria:
Exclusion Criteria:
For CAREGIVERS:
Inclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alain Kaelin, Prof. MD PhD | Contact | +41918117342 | alain.kaelin@eoc.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto di Neuroscienze Cliniche della Svizzera Italiana, EOC | Recruiting | Lugano | Switzerland |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| from baseline to the end of intervention (6weeks) |
| self-compassion level change in PD patients and caregivers | 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 | from baseline to the end of intervention (6weeks) |
| compassion level change in PD patients and caregivers | 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 | from baseline to the end of intervention (6weeks) |
| quality of life level change in caregivers | 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" | from baseline to the end of intervention (6weeks) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |