NCT07097298

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Nov 2025Jul 2027

First Submitted

Initial submission to the registry

July 17, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 6, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

July 17, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

Empathy(self-)compassionParkinson disease (PD)

Outcome Measures

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

    from baseline to the end of intervention (6weeks)

Secondary Outcomes (4)

  • change in the level of empathy in PD patients and caregivers

    from baseline to the end of intervention (6weeks)

  • self-compassion level change in PD patients and caregivers

    from baseline to the end of intervention (6weeks)

  • compassion level change in PD patients and caregivers

    from baseline to the end of intervention (6weeks)

  • quality of life level change in caregivers

    from baseline to the end of intervention (6weeks)

Study Arms (1)

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

Behavioral: empathy and compassion training

Interventions

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

Empathy and (self-)compassion training

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto di Neuroscienze Cliniche della Svizzera Italiana, EOC

Lugano, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Alain Kaelin, Prof. MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. MD PhD

Study Record Dates

First Submitted

July 17, 2025

First Posted

July 31, 2025

Study Start

November 6, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

December 1, 2025

Record last verified: 2025-11

Locations