Multiple Sclerosis Clinical Trial
— DIMMISIOfficial title:
A Randomized Controlled Trial on Integrated Imaginative Distention in MS Ans Insomnia: a Self Managed Tool to Cope With Fatigue, Stress and Insomnia
Verified date | March 2017 |
Source | Niguarda Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | December 2016 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - any gender, ethnicity - aged 18-65 years - ability to understand Italian to be able to conduct the study - adherence to the study by written informed consent - absence of serious internal medicine and psychiatric comorbidities Exclusion Criteria: - under 18 and above 65 years - lack of understanding Italian to conduct of the studies - inability to provide informed consent - presence of severe internal medicine and psychiatric comorbidities Specific criteria for inclusion: Pw MS: - Diagnosis according to the criteria of Polman, 2011: relapsing remitting or progressive (primary and secondary) - Or in no specific drug therapy for the disease and symptomatic Pw insomnia: - Diagnosis of psychophysiological insomnia according to DSM IV - Or in no specific drug therapy for the disease and symptomatic Healthy professionals: - Healthy personnel operating within the Niguarda Hospital |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda ospedaliera Ospedale Niguarda Ca' Granda | Milano |
Lead Sponsor | Collaborator |
---|---|
Niguarda Hospital |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Quality of life | Includes 54 items which generate 12 subscales with two summary scores, and two additional measures given by the single item. | month 2;month 3;month 6 | |
Secondary | Stress | It consists of 15 items and breaks down into five areas of evaluation which, when added, quantify the stress response: anxiety, depression, somatization, aggression, social support | month 2;follow-up (month 3;month 6) | |
Secondary | Insomnia | Consists of 7 items answered on a 4-point Likert scales, refers to the Mental Disorders Manual DSM-IV criteria for insomnia, and assesses the Individual impact of the symptoms in the last 2 weeks | month 2 | |
Secondary | Physiological parameters and Neurological evaluation | The EDSS is the most widely used to assess neurological disability with a score between 0 and 10 | month 2,month 3;month 6 | |
Secondary | Cognitive screening | Symbol Digit Modalities Test. Points 0-120. The California Verbal Learning Test - Second Edition. Points: 0-16 Visuospatial Memory Test - Revised. It takes 15 minutes. Points 0-36 | baseline,month 3 |
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