Parkinson DiseaseNCT05410769
Compassion Program for Parkinson
A study testing Compassion Focused Therapy in people with Parkinson Disease, run by Neuromed IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Compassion Focused Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Silvia Della Morte, psychologist contact
About this study
Official title: Compassionate Mind Training for Parkinson Patients and Caregivers
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.
Read the 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
- Being tested
- Compassion Focused Therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion Focused TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PD patients | Experimental | The intervention envisaged by the study takes place in the form of interviews, self-reports, and measurement of the heart rate variability. Receives: Behavioral: Compassion Focused Therapy |
| patient's caregivers | Experimental | The intervention envisaged by the study takes place in the form of interviews, self-reports, and measurement of the heart rate variability. Receives: Behavioral: Compassion Focused Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (4)
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.
Measured: week 0, week 9, week 12
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.
Measured: week 0, week 9, week 12
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).
Measured: week 0, week 9, week 12
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.
Measured: week 0, week 9, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Modugno, Neuromed IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410769
- Sponsor's protocol ID
- Compassion Focused Therapy
- Status last verified
- Jun 2022
- First submitted
- 17 Feb 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24588759
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Mind Training for Parkinson Patients and Caregivers
- ClinicalTrials.gov ID
- NCT05410769
- Acronym / sponsor ID
- Compassion Focused Therapy
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD patients | Experimental | Behavioral: Compassion Focused TherapyThe intervention envisaged by the study takes place in the form of interviews, self-reports, and measurement of the heart rate variability. |
| patient's caregivers | Experimental | Behavioral: Compassion Focused TherapyThe intervention envisaged by the study takes place in the form of interviews, self-reports, and measurement of the heart rate variability. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassion Focused TherapyThis 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. | Behavioural | PD patients, patient's caregivers |
Primary outcome
Compassion Mind Training online
Time frame: 6 weeks
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).
4 secondary outcomes
2. Beck Depression Inventory - II (BDI-II)
Time frame: week 0, week 9, week 12
Change in quality of life
Time frame: week 0, week 9, week 12
Anxiety state
Time frame: week 0, week 9, week 12
Change from baseline in isolated heart rate variability at 12 weeks post CMT
Time frame: week 0, week 9, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Background: PubMed 24588759Gilbert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Della Morte, psychologist contact
Questions about this trial
What is this clinical trial studying?
A study testing Compassion Focused Therapy in people with Parkinson Disease, run by Neuromed IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Modugno, MD (+39 3922571585, nicusmod@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compassion Mind Training online (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.