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Multiple SclerosisNCT02364505

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

A study testing Telemedicine mindfulness-based intervention and Psycho-education intervention in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis
What is being tested?
Telemedicine mindfulness-based intervention and Psycho-education intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteItaly
Study dates
Sep 2014to Dec 2016
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 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Francesco Pagnini

    Milan, Mi, 20871

Other trials in Italy

About this study

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

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.

Read the detailed description

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.

Being tested
Telemedicine mindfulness-based intervention, Psycho-education intervention
Keywords
caregivers
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine mindfulness-based interventionBehavioural

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

  • Psycho-education interventionBehavioural

    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.

Study groups in NCT02364505
Study groupRoleWhat they receive
Telemedicine mindfulness interventionExperimentalParticipants are assigned to a telemedicine mindfulness intervention group. The protocol lasts 8 weeks and it is composed by one online course session each week and home exercises. The course sessions, with a synchronous communication, will be conducted by a trainer, through teleconferences, that will explain how to practice the exercises to develop mindfulness attitude, following the mindfulness-based intervention-multiple sclerosis protocol. Subjects will be able to take part of these sessions everywhere, through a computer, tablet o mobile. During these sessions, individuals will interact with the trainer with teleconference or textual communications.
Receives: Behavioral: Telemedicine mindfulness-based intervention
Psycho-education control groupActive comparatorPsycho-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.
Receives: Behavioral: Psycho-education intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    All subjects will be assigned to psychometric assessment

    Measured: 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

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

    All subjects will be assigned to psychometric assessment

    Measured: 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

  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)

    All subjects will be assigned to psychometric assessment

    Measured: 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

Secondary outcomes (5)

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

    All subjects will be assigned to psychometric assessment

    Measured: 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

  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)

    All subjects will be assigned to psychometric assessment

    Measured: 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

  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

    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

    Measured: 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

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

    All subjects will be assigned to psychometric assessment

    Measured: 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

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

    All subjects will be assigned to psychometric assessment

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionNov 2016
  4. Study completionDec 2016

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02364505
Sponsor's protocol ID
23042013205901
Status last verified
Jan 2016
First submitted
29 Jan 2015
Last updated
3 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • Grossman P, Kappos L, Gensicke H, D'Souza M, Mohr DC, Penner IK, Steiner C. MS quality of life, depression, and fatigue improve after mindfulness training: a randomized trial. Neurology. 2010 Sep 28;75(13):1141-9. doi: 10.1212/WNL.0b013e3181f4d80d.

    PubMed 20876468

  • Whitebird RR, Kreitzer MJ, Lewis BA, Hanson LR, Crain AL, Enstad CJ, Mehta A. Recruiting and retaining family caregivers to a randomized controlled trial on mindfulness-based stress reduction. Contemp Clin Trials. 2011 Sep;32(5):654-61. doi: 10.1016/j.cct.2011.05.002. Epub 2011 May 12.

    PubMed 21601010

  • Teasdale JD, Segal Z, Williams JM. How does cognitive therapy prevent depressive relapse and why should attentional control (mindfulness) training help? Behav Res Ther. 1995 Jan;33(1):25-39. doi: 10.1016/0005-7967(94)e0011-7.

    PubMed 7872934

  • Manzoni GM, Pagnini F, Gorini A, Preziosa A, Castelnuovo G, Molinari E, Riva G. Can relaxation training reduce emotional eating in women with obesity? An exploratory study with 3 months of follow-up. J Am Diet Assoc. 2009 Aug;109(8):1427-32. doi: 10.1016/j.jada.2009.05.004.

    PubMed 19631051

  • Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.

    PubMed 7613530

  • Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002 Oct;59(10):877-83. doi: 10.1001/archpsyc.59.10.877.

    PubMed 12365874

  • Isaksson AK, Ahlstrom G. Managing chronic sorrow: experiences of patients with multiple sclerosis. J Neurosci Nurs. 2008 Jun;40(3):180-91.

    PubMed 18578277

  • Gay MC, Vrignaud P, Garitte C, Meunier C. Predictors of depression in multiple sclerosis patients. Acta Neurol Scand. 2010 Mar;121(3):161-70. doi: 10.1111/j.1600-0404.2009.01232.x. Epub 2010 Jan 12.

    PubMed 20070277

  • Feinstein A. Multiple sclerosis and depression. Mult Scler. 2011 Nov;17(11):1276-81. doi: 10.1177/1352458511417835.

    PubMed 22058085

  • Siegert RJ, Abernethy DA. Depression in multiple sclerosis: a review. J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):469-75. doi: 10.1136/jnnp.2004.054635.

    PubMed 15774430

  • Riether AM. Anxiety in patients with multiple sclerosis. Semin Clin Neuropsychiatry. 1999 Apr;4(2):103-13. doi: 10.1053/SCNP00400103.

    PubMed 10378954

  • Mendozzi L, Tronci F, Garegnani M, Pugnetti L. Sleep disturbance and fatigue in mild relapsing remitting multiple sclerosis patients on chronic immunomodulant therapy: an actigraphic study. Mult Scler. 2010 Feb;16(2):238-47. doi: 10.1177/1352458509354551. Epub 2009 Dec 22.

    PubMed 20028705

  • Tachibana N, Howard RS, Hirsch NP, Miller DH, Moseley IF, Fish D. Sleep problems in multiple sclerosis. Eur Neurol. 1994;34(6):320-3. doi: 10.1159/000117070.

    PubMed 7851452

  • Sateia MJ, Nowell PD. Insomnia. Lancet. 2004 Nov 27-Dec 3;364(9449):1959-73. doi: 10.1016/S0140-6736(04)17480-1.

    PubMed 15567013

  • Buchanan RJ, Radin D, Chakravorty BJ, Tyry T. Informal care giving to more disabled people with multiple sclerosis. Disabil Rehabil. 2009;31(15):1244-56. doi: 10.1080/09638280802532779.

    PubMed 19802928

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine mindfulness-based intervention and Psycho-education intervention in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

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 6 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: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. 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 NCT02364505, which also lists 35 linked publications.

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 3 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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