Feasibility and Effectiveness of a Mindfulness Program Delivered by Web to Patients During Hospitalization and Caregivers. (KIMPO)

Feasibility and Effectiveness of a Mindfulness Program Delivered by Web to Patients During Hospitalization and Caregivers: a Pilot Study (KMPO Project)

Hospitalization is often a traumatic event so stressful for the life of patients. Isolation, loneliness, worries about clinical examinations, results from examinations and final diagnosis, uncertainty about the future are the most common feelings that patients report when during hospitalized for different disease conditions; these feelings are not related to the pathological condition.

Also the discomfort of the caregivers is significant, as the necessities and priorities of the family change significantly during the hospitalization of a member (worries about the future, help and support are not enough to sustain the situation, problems with the work schedule ). Nowadays in North American and North European countries, mindfulness practice is offered to patients by multifaith Chaplaincy teams and health-care operators (e.g. physicians, nurses, psychologists), as a way of helping patients come to terms with diagnosis and adjust to their prognosis. To the extent that patients can bear it, instructions are given to keep coming back to the present moment, here and now, to bodily and affective experience, relaxing in it. To that purpose patients are encouraged to accept the situation as it develops, and let go of excessive concerns and unhelpful narratives that undermine the capacity to manage pain, fear and suffering. Moreover, similar programmes are designed for caregivers and the patients' families, aimed at developing their resilience in delivering the support, via face-to-face sessions, and instructions and encouragement for a regular practice at home.

In the last years, due to the dramatic emergency for the COVID-19 pandemic, different applications for mindfulness have been realized by specific APPs or web platforms that allow patients to practice mindfulness regularly guided by a physician or an expert in mindfulness: patients can stay at home and mindfulness sessions can be delivered by technological modalities. In different hospitals, protocols have been implemented for the treatment of patients remotely, using specific platforms or APPs. These remote interventions are complementary to the regular face-to-face sessions and they are suitable for most patients and easily applied.

Study Overview

• Status: Recruiting
• Conditions: Chronic Migraine; Multiple Sclerosis; Motoneuron Disease
• Intervention / Treatment: Other: no comparator - TAU (Treatment-as-usual)

Detailed Description

Background: Hospitalization is often a traumatic event so stressful for the life of patients. Isolation, loneliness, worries about clinical examinations, results from examinations and final diagnosis, uncertainty about the future are the most common feelings that patients report when they are hospitalized for different disease conditions; these states of mind may be experienced independently of the type of pathological condition they are affected by Also the discomfort of the caregivers is significant, as the necessities and priorities of the family change significantly during the hospitalization of a member (worries about the future, help and support are not enough to sustain the situation, problems with the work schedule ) Significance: The practice of mindfulness has become common in different clinical applications, pain, anxiety and other kinds of disease. In particular protocols based on mindfulness practice are often combined to pharmacological therapies, as initial findings support the utility of mindfulness intervention to modulate attention and emotional reactions to pain chronification Meditation has a long history of use for increasing calmness and physical relaxation, improving psychological balance, coping with illness, and enhancing overall health and well-being. The practice has the purpose to teach individuals how to maintain focus on a stimulus while simultaneously allowing intruding thoughts/feelings to be acknowledged, but not judged.

Hospitalization is often a traumatic event so stressful for the life of patients. Isolation, loneliness, worries about clinical examinations, results of examinations and final diagnosis, uncertainty about the future are the most common feelings that patients report during hospitalization for different disease conditions; these states of mind may be experienced independently of the type of pathological condition the patients are affected by.

Also the discomfort of the caregivers is significant, as the necessities and priorities of the family change significantly during the hospitalization of a member (worries about the future, help and support are not enough to sustain the situation Nowadays in North American and North European countries, mindfulness practice is offered to patients by multifaith Chaplaincy teams and health-care operators (e.g. physicians, nurses, psychologists), as a way of helping them come to terms with the diagnosis and adjust to their prognosis. To the extent that they can bear it, instructions are given to keep coming back to the present moment, here and now, to bodily and affective experience, relaxing in it. To that purpose patients are encouraged to accept the situation as it develops, and let go of excessive concerns and unhelpful narratives that undermine the capacity to manage pain, fear and suffering.

Moreover, similar programmes are designed for caregivers and the patients' families, aimed at developing resilience in delivering their support, via face-to-face sessions, and instructions and encouragement for a regular practice at home.

In the last years, due to the dramatic emergency for the COVID-19 pandemic, different applications for mindfulness have been realized by specific APPs or web platforms that allow patients to practice mindfulness regularly guided by a physician or an expert in mindfulness: patients can stay at home and mindfulness sessions can be delivered by technological modalities.

In several hospitals, different protocols have been implemented for the treatment of patients remotely, using specific platforms or APPs. These remote interventions are complementary to the regular face-to-face sessions and they are suitable for most patients and easily applied.

• Study Type: Interventional
• Enrollment (Anticipated): 1
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renato MI Mantegazza, MD; Phone Number: 3568 +39022394; Email: crc@istituto-besta.it
• Study Contact Backup: Name: Licia MI Grazzi, MD; Phone Number: 2366 +39022394; Email: licia.grazzi@istituto-besta.it

Study Locations

• Italy
  • Milano, Italy, 20133
    • Recruiting
    • Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit
    • Contact: Licia Grazzi, MD; Email: licia.grazzi@istituto-besta.it
    • Principal Investigator: Licia Grazzi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients aged between 18 and 70 yrs; patients hospitalized at our neurological department; patients at the day hospital service

Patients (age from 18 to 70 yrs) hospitalized suffering from: Chronic migraine with medication overuse; Neuropathic Pain; Multiple Sclerosis are included into the project and caregivers

Exclusion Criteria:

patients not able to understand the italian language; patients with confirmed psychiatric comorbidities; patients who are not able to understand the consent module form and sign it; (or patients with mental capacity issues)

Caregivers aged between 18-70 yrs old, will be admitted into the study if they fall in the 18-70 years age bracket, and understand the Italian language , in the absence of psychiatric conditions (reported specific therapy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: TAU + MINDF (Treatment-as -Usual + Mindfulness); Treatment-as-usual combined with weekly mindfulness sessions delivered on-line for patients and caregivers (a specific platform for on-line sessions will be used)

Other: no comparator - TAU (Treatment-as-usual); Learning the ability in mindfulness practice by specific measure (FFMQ) changes in FIVE FACET MINDFULNESS QUESTIONNAIRE (FFMQ) compared to baseline): this questionnaire measures the mindfulness ability of patients before and after the APP application (minimum score 113.7-low mindfulness ability=worse outcome ; maximum score 144.3-high mindfulness ability=better outcome) [Time Frame: At Three-six months] Introduction of the mindfulness program during a preliminary face-to-face session to patients and caregivers TAU Weekly mindfulness sessions delivered on-line for patients and caregivers (a specific platform for on-line sessions will be used)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MINDFULNESS	Learning the ability in mindfulness practice by specific measure (FFMQ) changes in FIVE FACET MINDFULNESS QUESTIONNAIRE (FFMQ) compared to baseline): this questionnaire measures the mindfulness ability of patients before and after the APP application (minimum score 113.7-low mindfulness ability=worse outcome ; maximum score 144.3-high mindfulness ability=better outcome) [Time Frame: At Three-six months]	Three-six months

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Investigators: Principal Investigator: Licia MI Grazzi, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: KIMPO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No