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

NCT02290990 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2017-04-04

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

"Imaginative Distention" technique

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).

Sponsors & Collaborators

  • Niguarda Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-10-31
Completion
2016-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02290990 on ClinicalTrials.gov