Brief Summary

Imaginative Distention (ID) is proposed as supportive and integrative intervention to cope with fatigue, (principal end point), to cope with insomnia, stress perception and to improve QoL of pw MS, insomnia pw and health care personnel. ID is safe and it can be easily learned and practised without of any particular instrument and also feasible in disabled pw. This technique allows persons to experience the body as a source of well-being and not just fatigue, pain and disease. ID can become a self managed tool of empowerment to cope with MS, to reduce its negative impact on daily life and job performances. Adherence to pharmacological therapies could be improved using ID. For pw MS ID could have specific and customizable rehabilitation implications to improve motor disability, as already seen in stroke patients. The principal end point of the trial is verify ID efficacy on fatigue and its specificity on pw MS at the end of the training. For this reason, ID efficacy will be tested in comparative terms too. Among all possible comparison populations, we selected: pw insomnia, which is stress related disease and health personnel, because at risk of stress. The control groups comparison permits to evaluate the specificity of ID on pw MS. The three groups are randomised to intervention or waiting list. The training is 8 weekly session long. Self administered questionnaire are filled by participants before and after the training, and 3-6 months later. The extent of change in outcome measure monitored in each exposed group vs. unexposed will allow to separate the non-disease specific effect of ID from the MS-specific effect. The difference in estimates will allow to determine the extent of the true effect of ID in pw MS. All outcome measure will be compared among all groups mentioned and over time. The study would identify also the most important outcome measures for MS patients questioning them in a focus group. This aspect is very important because could differs from which clinicians and researchers think about.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

144

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline

Completed

Started Sep 2014

Typical duration for not_applicable multiple-sclerosis

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

September 1, 2014

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed

1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed

Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

October 7, 2014

Last Update Submit

March 31, 2017

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

Fatigue
Evaluated with MFIS self administered questionnaire.Modified Fatigue Impact Scale (MFIS) is a self-assessment,values fatigue on daily life impact. Provides 21 items with 5-point Likert scale answer (from 0 = never to 4 = almost always).Total score ranges from 0 to 84 and includes three subscales:physical,cognitive and psychosocial fatigue (score ranges between 0-8)
Change from baseline in MFIS score at two months + one week

Secondary Outcomes (5)

Quality of life
month 2;month 3;month 6
Stress
month 2;follow-up (month 3;month 6)
Insomnia
month 2
Physiological parameters and Neurological evaluation
month 2,month 3;month 6
Cognitive screening
baseline,month 3