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Completed

NCT Number: NCT02364505

A Telemedicine Mindfulness-based Intervention for People With Multiple Sclerosis and Their Caregivers

The aim of the project is to investigate the impact of a multiple sclerosis specific telemedicine mindfulness-based Intervention on the quality of life of people with multiple sclerosis and their caregivers.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Francesco Pagnini

Milan, Mi, 20871, Italy

About this study

The mindfulness protocol will be modified according to multiple sclerosis clinical peculiarities and implemented with a multimedia web-based software.

The project will be divided in two parts. During the first phase of the project, a standard mindfulness-based stress reduction protocol will be modified according to clinical peculiarities and specific needs of people with multiple sclerosis. In the meanwhile, a multimedia software with these teaching will be developed, so that the training could be available online, from home. The protocol and the software will be tested for ergonomics in a pilot, qualitative, study.

In the second phase, a randomized clinical trial will be performed. One-hundred and twenty multiple sclerosis patients-caregivers couples will be randomly allocated in the experimental or to the control group. Subjects in the experimental group will attend the telemedicine mindfulness intervention, while controls will join a psycho-educational telemedicine program. At baseline, post-treatment and at a 6-month follow-up, participants will be assessed for quality of life, anxiety, depression, quality of sleep and mindfulness level. A subgroup of subjects will be assessed with actigraphs, for an objective evaluation of their sleep and physical activity. Experimental subjects will be assessed for participation and engagement to the treatment. Data will be analyzed with a complex longitudinal design, considering both within and between groups comparisons.

The dissemination process will involve scientific publication on neurological and psychological journals, a book, scientific meeting presentations and communication to general media. If there will be a positive effect of the mindfulness software, it will be diffused to multiple sclerosis clinics and associations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of relapsing-remitting or secondary progressive multiple sclerosis.
  • Ability to communicate and to understand tasks.
  • No change of disease-modifying treatment in the 3 months before the enrolment.
  • No clinical relapses or use of steroid treatment during the 4 weeks before the enrolment.
  • Availability of a personal computer, smartphone or tablet (compatible with the software).
  • Provided informed consent for study participation.

Exclusion criteria

  • Being a person who lives with the multiple sclerosis patient and provides him/her with most care and assistance
  • Ability to communicate and to understand tasks
  • Availability of a personal computer, smartphone or tablet (compatible with the software).
  • Provided informed consent for study participation

Treatment and study plan

Telemedicine mindfulness-based intervention

Behavioral

Comparison of telemedicine mindfulness intervention with telemedicine psycho-education control group

Psycho-education intervention

Behavioral

Psycho-education control group, provided with a telemedicine approach. Subject in this group will use a similar software than the experimental intervention, with identical time efforts required. Software contents will be psycho-educative.

Primary outcomes

  1. Evidence of an improved quality of life in patients with multiple sclerosis as measured by The Multiple Sclerosis Quality of Life-54 (MSQOL-54)

    Time frame: First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention

    All subjects will be assigned to psychometric assessment

  2. Evidence of an improved quality of life in caregivers as measured by the Short-Form-36 (SF-36)

    Time frame: First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention

    All subjects will be assigned to psychometric assessment

  3. Evidence of a decrease of anxiety and depression in patients with multiple sclerosis and in caregivers as measured by the Hospital Anxiety and Depression Scale (HADS)

    Time frame: First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention

    All subjects will be assigned to psychometric assessment

Secondary outcomes

  1. Evidence of an attained mindfulness level in patients with multiple sclerosis and in caregivers as measured by the Langer Mindfulness Scale (LMS)

    Time frame: first assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention

    All subjects will be assigned to psychometric assessment

  2. Evidence of a decrease of sleep disturbance and better quality of sleep in patients with multiple sclerosis and in caregivers as measured by the Medical Outcomes Study Sleep Measure (MOSssm)

    Time frame: First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention

    All subjects will be assigned to psychometric assessment

  3. Evidence of a decrease of sleep disturbance and fatigue and a better quality of sleep in patients with multiple sclerosis as measured by actigraphy unit

    Time frame: First assessment includes the entires two weeks preceding the start of the intervention (baseline condition); second assessment includes the entire two weeks after the end of the intervention

    40 subjects will receive an actigraphy, a non-invasive method of monitoring human rest/activity cycles, that can be worn to measure gross motor activity

  4. Evidence of a decrease in fatigue in patients with multiple sclerosis and in caregivers as measured by the Modified Fatigue Impact Scale (MFIS)

    Time frame: First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention

    All subjects will be assigned to psychometric assessment

  5. Evidence of a decrease in caregiver burden as measured by the Zarit Burden Interview (ZBI)

    Time frame: First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention

    All subjects will be assigned to psychometric assessment

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • Catholic University of the Sacred Heart

Registry information

Official study title

Improving the Quality of Life of People With Multiple Sclerosis and Their Caregivers With a Telemedicine Mindfulness-Based Intervention

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2015
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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