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Compassion Program for Parkinson

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compassion Focused Therapy
Sponsored by
Neuromed IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    PD patients

    patient's caregivers

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    2. Beck Depression Inventory - II (BDI-II)
    Self-report questionnaire, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.
    Change in quality of life
    Change from baseline in quality of life measured with the Parkinson Disease Questionnaire-39. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month covering 8 dimensions scored on a 5 point ordinal system (0=never, 4=always). Lower scores reflect better QoL.
    Anxiety state
    The State-Trait Anxiety Inventory (STAI-Y) A which assessed the anxiety state (20 items; range, 20-80; < 35 = very low anxiety state, 36-45 = low anxiety state, 46-55 = medium anxiety state, 56-65 = high anxiety state, >65 = very high anxiety state).
    Change from baseline in isolated heart rate variability at 12 weeks post CMT
    Pulse measurements at each online visit before and after the treatment period, At 3 time points during the online visit: 1-resting, 2-deep breathing, 3- post trigger interview. The incidence of clinically significant abonormal values will be summarized using descriptive statistics.

    Full Information

    First Posted
    February 17, 2022
    Last Updated
    June 5, 2022
    Sponsor
    Neuromed IRCCS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05410769
    Brief Title
    Compassion Program for Parkinson
    Official Title
    Compassionate Mind Training for Parkinson Patients and Caregivers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2022 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    May 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Neuromed IRCCS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PD patients
    Arm Type
    Experimental
    Arm Description
    The intervention envisaged by the study takes place in the form of interviews, self-reports, and measurement of the heart rate variability.
    Arm Title
    patient's caregivers
    Arm Type
    Experimental
    Arm Description
    The intervention envisaged by the study takes place in the form of interviews, self-reports, and measurement of the heart rate variability.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Compassion Focused Therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Compassion Mind Training online
    Description
    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).
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    2. Beck Depression Inventory - II (BDI-II)
    Description
    Self-report questionnaire, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.
    Time Frame
    week 0, week 9, week 12
    Title
    Change in quality of life
    Description
    Change from baseline in quality of life measured with the Parkinson Disease Questionnaire-39. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month covering 8 dimensions scored on a 5 point ordinal system (0=never, 4=always). Lower scores reflect better QoL.
    Time Frame
    week 0, week 9, week 12
    Title
    Anxiety state
    Description
    The State-Trait Anxiety Inventory (STAI-Y) A which assessed the anxiety state (20 items; range, 20-80; < 35 = very low anxiety state, 36-45 = low anxiety state, 46-55 = medium anxiety state, 56-65 = high anxiety state, >65 = very high anxiety state).
    Time Frame
    week 0, week 9, week 12
    Title
    Change from baseline in isolated heart rate variability at 12 weeks post CMT
    Description
    Pulse measurements at each online visit before and after the treatment period, At 3 time points during the online visit: 1-resting, 2-deep breathing, 3- post trigger interview. The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
    Time Frame
    week 0, week 9, week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicola Modugno, MD
    Phone
    +39 3922571585
    Email
    nicusmod@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Silvia Della Morte, psychologist
    Email
    silviadellamorte@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24588759
    Citation
    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.
    Results Reference
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