Empathy and (Self-)Compassion in Parkinson's Disease Patients and Caregivers

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease(PD)

• Registration Number: NCT07097298
• Lead Sponsor: Alain Kaelin

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Primary Completion: 2027-07
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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"

Trial Locations

Locations (1)

Istituto di Neuroscienze Cliniche della Svizzera Italiana, EOC; 🇨🇭 Lugano, Switzerland