Ignite Creation Date:
2024-05-06 @ 3:27 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02290990
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2014-10-07
Brief Title:
Efficacy Study of Imaginative Distention a Self Managed Tool to Cope With FatigueInsomnia and Stress in pw Insomnia and pw MS
Sponsor:
Niguarda Hospital
Organization:
Niguarda Hospital
Study Overview
Official Title:
A Randomized Controlled Trial on Integrated Imaginative Distention in MS Ans Insomnia a Self Managed Tool to Cope With Fatigue Stress and Insomnia
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIMMISI
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
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
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 and psychological impact on persons with MS pw MS Fatigue depression and disability are independent determinants of quality of life QoL and it is known that different kinds of stress may impact on disease activity The Imaginative Distention ID is a mind-body technique that combines relaxation imagination and motor imagery ID derives from Progressive Muscle Relaxation Technique PMRT that was shown effective on fatigue in MS and in cancer patients as well as cognitive behavioural psychotherapy which includes relaxation Mind-body modalities appear safe ID can be easily learned and practised without any particular instrument and is also feasible in disabled pw MS The aim of our study is to evaluate the effectiveness of ID as supportive and integrative intervention to cope with MS We plan the first randomized controlled study RCT that will investigate the effectiveness of ID on fatigue primary end point disease specific QoL insomnia stress perception and physiological parameters The primary outcome is the change in fatigue recorded post-intervention Fatigue has a generically stress-related and a specifically disease-related component To estimate the effect of ID on the specific MS-related component of fatigue we will also monitor two additional groups of subjects one with insomnia with fatigue and poor QoL but with lesser impact on health condition and one under generic stress health professionals with fatigue and normal to poor QoL and limited if any impact on health condition Each study group - MS insomnia health professionals - will be randomised 11 to intervention or waiting list The design is therefore parallel randomised controlled vs no intervention open stratified by condition Enrolment is voluntary All participants will undergo a pre-evaluation visit which includes four self administered questionnaires MFIS for fatigue VRS Verbal Rating Scale for stress ISI Insomnia Severity Index MSQOL-54 Multiple Sclerosis Quality of Life the EDSS Expanded Disability Status Scale and a brief cognitive screening for pw MS After randomization ID is practiced in groups once a week for two months At the end pw MS will be involved in focus groups to identify the agreement between investigator selected and patients-expected relevance of the outcomes used in the study as well as other outcomes of relevance for the patients but not monitored in the study to be possibly implemented in future trials Follow up evaluations at two five and eight months will include EDSS and the self-administered questionnaires and at five months the cognitive screening If efficacy will be proved ID could become a tool of empowerment to cope with MS to reduce its negative impact on daily life and job performances and possibly to improve the adherence to pharmacological therapies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None