Efficacy Study of "Imaginative Distention", a Self Managed Tool to Cope With Fatigue,Insomnia and Stress in pw Insomnia and pw MS

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 1:1 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.