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

NCT02364505 | Completed

• 1 other identifier: 23042013205901
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

caregivers

Outcome Measures

Primary Outcomes (3)

• 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

  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

• 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

  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

• 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

  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)

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

  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

• 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)

  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

• 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

  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

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

  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

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

  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

Study Arms (2)

Telemedicine mindfulness intervention

EXPERIMENTAL

Participants 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.

Behavioral: Telemedicine mindfulness-based intervention

Psycho-education control group

ACTIVE COMPARATOR

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.

Behavioral: Psycho-education intervention

Interventions

Telemedicine mindfulness-based intervention BEHAVIORAL

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

Telemedicine mindfulness intervention

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.

Psycho-education control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

Francesco Pagnini

Milan, Mi, 20871, Italy

Location

Related Publications (35)

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• Cavalera C, Rovaris M, Mendozzi L, Pugnetti L, Garegnani M, Castelnuovo G, Molinari E, Pagnini F. Online meditation training for people with multiple sclerosis: A randomized controlled trial. Mult Scler. 2019 Apr;25(4):610-617. doi: 10.1177/1352458518761187. Epub 2018 Feb 27.

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• Cavalera C, Pagnini F, Rovaris M, Mendozzi L, Pugnetti L, Garegnani M, Molinari E. A telemedicine meditation intervention for people with multiple sclerosis and their caregivers: study protocol for a randomized controlled trial. Trials. 2016 Jan 4;17:4. doi: 10.1186/s13063-015-1136-9.

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MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 18, 2015
• Study Start: September 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 3, 2017

Record last verified: 2016-01

Locations

IT (1)