A Randomized Controlled Trial on Integrated Imaginative Distention in MS Ans Insomnia: a Self Managed Tool to Cope With Fatigue, Stress and Insomnia

CompletedNot a drug-phase studyMS (type not specified)NCT02290990

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • "Imaginative Distention" technique

What it measured

Main measures

  • Fatigue

    Change from baseline in MFIS score at two months + one week

    Thinking and memoryFatigue

Other measures (5)

  • Quality of life

    month 2;month 3;month 6

    Quality of life (reported by participants)
  • Stress

    month 2;follow-up (month 3;month 6)

    Mood and sleep
  • Insomnia

    month 2

    Mood and sleep
  • Physiological parameters and Neurological evaluation

    month 2,month 3;month 6

    Disability progression
  • Cognitive screening

    baseline,month 3

    Thinking and memory

Who could take part

MS (type not specified) · 18 to 65

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Sept 2014

    2. Main results due

      Oct 2015

    3. Finished

      Dec 2016

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