Compassion Program for Parkinson

NCT ID: NCT05410769

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2023-05-31

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.

Detailed Description

Non-motor symptoms in Parkinson's disease are classified in sensory, autonomic, behavioral, cognitive, sleep and psychic disorders. The most frequently presented neuropsychiatric symptoms are anxiety, depression, apathy, and impulsivity.

Although there are many false beliefs that patients often construct about their disease, PD patients still maintain a certain lucidity throughout the duration of the disease and its degeneration, improving the anxious-depressive symptoms. Psychic disorders can affect the patient's awareness of self-efficacy and self-regulation, as well as decision making capacity, mechanisms connected with dopaminergic circuits, the main target of PD neurodegeneration.

Parallel to the onset of symptoms in the patient, there is a great involvement of the caregivers who, aggravated by the emotional and welfare burden, develop over time stress, burden and burnout syndromes. The quality of life of caregivers undergo an objective impoverishment attributable to the inevitable alterations of free time and social relationships, in addition to a clinical psychophysical outcome.

Although there are numerous effective pharmaco-therapeutic approaches for motor symptoms, still little attention is paid to the prevention and treatment of neuropsychiatric symptoms.

Although there are still few studies, a new perspective of integrated care has gain attention due to the advantage of being able to be adapted to the needs and characteristics of the individual patient, enabling to choose the complementary / integrated therapy modality that best suits personal needs.

Within psychology, mindfulness practices such as MBSR Mindfulness protocols for stress have been successfully applied in different settings and on both patients and caregivers.

In the last twenty years, Compassion Focused Therapy practices increased within clinical practice, proving to be an adequate tool for improving psychophysical well-being. Compassion derives from the attachment behavioral system typical of mammals and allows the regulation of basic emotional systems. Compassion is divided into three streams: compassion towards oneself (Self-Compassion), compassion towards others and received from others. In particular, training one's Self Compassion through a Compassionate Mind Training can lead to proactive behaviors that improve the quality of one's life rather than enduring in a condition of passivity. Scientific research shows reliable data on the fact that awareness and compassion practices have physiological as well as psychological effects, acting on digestion, blood pressure, interbeat variability, but also on neuronal circuits. Recent studies correlate the levels of Compassion with a variation in HRV (heart rate variability) levels and has been suggested as a biomarker reliable in detecting the functions of the autonomic system. Variations in HRV values have been associated with autonomic dysfunctions, mood fluctuations and anxiety states in healthy subjects and subjects with generalized anxiety disorder.

Due to the persistent and still present pandemic emergency, the psychological symptoms are exacerbated by the general state of anxiety and uncertainty as well as by the inability to access public services. The conception of this "online study" is to allow a considerable possibility of interconnection and exchange, much easier in terms of technological means and timing.

This pilot study aims to propose for the first time an online Compassion (Compassion Program for Parkinson) protocol to a group of patients with PD and a group of caregivers and to evaluate its feasibility and effectiveness.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PD patients

The intervention envisaged by the study takes place in the form of interviews, self-reports, and measurement of the heart rate variability.

Group Type: EXPERIMENTAL

Compassion Focused Therapy

Intervention Type: BEHAVIORAL

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.

patient's caregivers

The intervention envisaged by the study takes place in the form of interviews, self-reports, and measurement of the heart rate variability.

Group Type: EXPERIMENTAL

Compassion Focused Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

Compassion Focused Therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuromed IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Nicola Modugno

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nicola Modugno, MD

Role: CONTACT

nicusmod@gmail.com

+39 3922571585

Silvia Della Morte, psychologist

Role: CONTACT

silviadellamorte@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 24588759 (View on PubMed)

Other Identifiers

Compassion Focused Therapy

Identifier Type: -

Identifier Source: org_study_id