Status:
COMPLETED
Efficacy Study of "Imaginative Distention", a Self Managed Tool to Cope With Fatigue,Insomnia and Stress in pw Insomnia and pw MS
Lead Sponsor:
Niguarda Hospital
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
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, in...
Detailed Description
Multiple sclerosis (MS) is a chronic neurological disorder with physical, emotional and cognitive symptoms. The diagnosis and the unpredictable and variable nature of the disease have profound social ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT02290990
Start Date
September 1 2014
End Date
December 1 2016
Last Update
April 4 2017
Active Locations (1)
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1
Azienda ospedaliera Ospedale Niguarda Ca' Granda
Milan, Italy, 20162