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Parkinson DiseaseNCT05410769

Compassion Program for Parkinson

A study testing Compassion Focused Therapy in people with Parkinson Disease, run by Neuromed IRCCS.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Nicola Modugno, MD contact

+39 3922571585

nicusmod@gmail.com

Silvia Della Morte, psychologist contact

silviadellamorte@gmail.com

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.

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 groups in NCT05410769
Study groupRoleWhat they receive
PD patientsExperimentalThe 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 caregiversExperimentalThe 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.

  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).

    Measured: 6 weeks

Secondary outcomes (4)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted8 Jun 2022
  2. Study startJul 2022 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionMay 2023 (estimated)

Resources

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)
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

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.

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