Parkinson Disease(PD)NCT07097298
Empathy and (Self-)Compassion in Parkinson's Disease Patients and Caregivers
A study testing empathy and compassion training in people with Parkinson Disease(PD), run by Alain Kaelin at 1 site in Switzerland.
Trial 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?… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease(PD)
- What is being tested?
- empathy and compassion training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Nov 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Istituto di Neuroscienze Cliniche della Svizzera Italiana, EOC
Lugano
Alain Kaelin, Prof. MD PhD, +41 (0)91 811 73 42, alain.kaelin@eoc.ch
About this study
Official title: Empathy and (Self-)Compassion to Improve the Quality of Life of Parkinson's Disease Patients and Caregivers: an Exploratory Study
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
- Conditions
- Parkinson Disease(PD)
- Being tested
- empathy and compassion training
- Keywords
- Empathy, (self-)compassion, Parkinson disease (PD)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empathy and compassion trainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: empathy and compassion training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from baseline to the end of intervention (6weeks)
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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"
Measured: from baseline to the end of intervention (6weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start6 Nov 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease(PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alain Kaelin
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor-investigator, Alain Kaelin, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097298
- Sponsor's protocol ID
- EMPCOMP-PD-001
- Status last verified
- Nov 2025
- First submitted
- 17 Jul 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empathy and (Self-)Compassion to Improve the Quality of Life of Parkinson's Disease Patients and Caregivers: an Exploratory Study
- ClinicalTrials.gov ID
- NCT07097298
- Acronym / sponsor ID
- EMPCOMP-PD-001
- Conditions
- Parkinson Disease(PD)
- Keywords
- Empathy, (self-)compassion, Parkinson disease (PD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alain KaelinUniversity, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Empathy and (self-)compassion training | Experimental | Behavioral: empathy and compassion trainingA 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 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| empathy and compassion trainingA 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 | Behavioural | Empathy and (self-)compassion training |
Primary outcome
PD patients quality of life improvement
Time frame: 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
4 secondary outcomes
change in the level of empathy in PD patients and caregivers
Time frame: from baseline to the end of intervention (6weeks)
self-compassion level change in PD patients and caregivers
Time frame: from baseline to the end of intervention (6weeks)
compassion level change in PD patients and caregivers
Time frame: from baseline to the end of intervention (6weeks)
quality of life level change in caregivers
Time frame: from baseline to the end of intervention (6weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing empathy and compassion training in people with Parkinson Disease(PD), run by Alain Kaelin at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain Kaelin, Prof. MD PhD (+41918117342, alain.kaelin@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PD patients quality of life improvement (time frame: from baseline to the end of intervention (6weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.