Health TrialsbyHealthPanel

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

ConditionParkinson Disease(PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorAlain Kaelin

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Empathy and (self-)compassion trainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
from baseline to the end of intervention (6weeks)

Secondary outcomes

1

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

Time frame
from baseline to the end of intervention (6weeks)
2

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

Time frame
from baseline to the end of intervention (6weeks)
3

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

Time frame
from baseline to the end of intervention (6weeks)
4

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"

Time frame
from baseline to the end of intervention (6weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alain Kaelin

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Sponsor institution

CTU-EOC Clinical Trial Unit Ente Ospedaliero Cantonale

Collaborator

Source ClinicalTrials.gov
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