Efficacy Study of "Imaginative Distention", a Self Managed Tool to Cope With Fatigue,Insomnia and Stress in pw Insomnia and pw MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sleep Initiation and Maintenance Disorders
Study type: Interventional

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.
    

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
      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.
    

Intervention name(s): "Imaginative Distention" technique
Intervention type(s): Behavioral
Intervention description(s): ID is an Imaginative relaxation technique which combines physical and mental relaxation. ID technique reaches physical relaxation through planned alternated movements taken from Jacobson PMRT which consist of specific muscle contractions and subsequent relaxations, with a precise temporal scanning. Psychological relaxation is achieved thanks to mental imagery (motor imagery, body scan, imagination).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment