Compassion Program for Parkinson
Compassionate Mind Training for Parkinson Patients and Caregivers
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Parkinson's disease (PD) is a chronic and progressive neurodegenerative disease of the central nervous system. Second only to Alzheimer's in incidence on the population, Parkinson's disease has a negative impact on the quality of life of both patients and caregivers. Despite the prevailing attention to motor symptoms, such as bradykinesia, tremor and rigidity, the typical Parkinsonian symptom includes a wide range of non-motor symptoms that invalidate various aspects of the patient's autonomy, cognitive, behavior and mood that impact on patients' quality of life and that of caregivers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Jul 2022
Shorter than P25 for not_applicable parkinson-disease
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
First Submitted
Initial submission to the registry
February 17, 2022
CompletedFirst Posted
Study publicly available on registry
June 8, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedJune 8, 2022
June 1, 2022
2 months
February 17, 2022
June 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Compassion Mind Training online
Patients and Caregivers report on the Compassion Scale (Gilbert P. Compassion-focused therapy: Preface and introduction for special section. Br J Clin Psychol. 2014 Mar;53(1):1-5. doi: 10.1111/bjc.12045. PMID: 24588759.). CMT is a 6-session program, each lasting about 2 hours, which run on a weekly basis. The program is organized across 3 modules: 1) Our mind according to a compassion-based approach (to provide insight into the evolved and socially shaped mind and the affect regulation systems); 2) Compassionate mind training (understanding and cultivating the attributes and competencies of compassion in its three flows, and addressing its fears); and 3) final session (revising key information and practices and its application to the online routines).
6 weeks
Secondary Outcomes (4)
2. Beck Depression Inventory - II (BDI-II)
week 0, week 9, week 12
Change in quality of life
week 0, week 9, week 12
Anxiety state
week 0, week 9, week 12
Change from baseline in isolated heart rate variability at 12 weeks post CMT
week 0, week 9, week 12
Study Arms (2)
PD patients
EXPERIMENTALThe intervention envisaged by the study takes place in the form of interviews, self-reports, and measurement of the heart rate variability.
patient's caregivers
EXPERIMENTALThe intervention envisaged by the study takes place in the form of interviews, self-reports, and measurement of the heart rate variability.
Interventions
This pilot study aims to propose for the first time a Compassion protocol (Compassion Program for Parkinson) to a group of patients with PD and a group of caregivers and to evaluate its feasibility and effectiveness. The investigators aim to assess whether the program is effective in improving the quality of life and psychiatric symptoms of the patients and caregivers. The Compassion program is a healthy form of self- acceptance, which involves being touched by one's own suffering, along with the desire to alleviate it and treat oneself with understanding and kindness. The duration of the protocol will be 6 weeks (1 meeting/ week of 2 hours). The investigators will recruit 40 patients and 20 caregivers who will be assessed pre and post intervention (Compassionate Mind Training) with interviews, self reports and measurement of the heart rate variability.
Eligibility Criteria
You may qualify if:
- PD diagnosis according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (UKPDS)
- Ability to provide written informed consent
- Age between 18 and 80 years (inclusive)
You may not qualify if:
- cognitive impairment
- Inability to provide written informed consent
- any cardiological condition/drugs that alter the heartbeat
- Diagnosis of other concomitant neurodegenerative disease or psychiatric diaseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuromed IRCCSlead
Related Publications (1)
Gilbert P. Compassion-focused therapy: Preface and introduction for special section. Br J Clin Psychol. 2014 Mar;53(1):1-5. doi: 10.1111/bjc.12045. No abstract available.
PMID: 24588759BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 17, 2022
First Posted
June 8, 2022
Study Start
July 1, 2022
Primary Completion
September 1, 2022
Study Completion
May 1, 2023
Last Updated
June 8, 2022
Record last verified: 2022-06