Multiple SclerosisDIMMISINCT02290990
Efficacy Study of "Imaginative Distention", a Self Managed Tool to Cope With Fatigue,Insomnia and Stress in pw Insomnia and pw MS
A study testing "Imaginative Distention" technique in people with Multiple Sclerosis, run by Niguarda Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- "Imaginative Distention" technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- "Imaginative Distention" technique
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Imaginative Distention" techniqueBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis patients | Experimental | Patients with MS Receives: Behavioral: "Imaginative Distention" technique |
| Insomnia patients | Experimental | Patients with insomnia Receives: Behavioral: "Imaginative Distention" technique |
| Health professionists | Experimental | Health professionists as healthy volunteers Receives: Behavioral: "Imaginative Distention" technique |
| Waiting list MS | Active comparator | pw MS filled the self administered questionnaire but they receive any training. They must wait study conclusion to be treated Receives: Behavioral: "Imaginative Distention" technique |
| Waiting list arm Insomnia | Active comparator | pw INS Insomnia Subject filled the self administered questionnaire but they receive any training. They must wait study conclusion to be treated Receives: Behavioral: "Imaginative Distention" technique |
| Waiting list arm Health professionists | Active comparator | Health professionist filled the self administered questionnaire but they receive any training. They must wait study conclusion to be treated. Receives: Behavioral: "Imaginative Distention" technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Evaluated with MFIS self administered questionnaire.Modified Fatigue Impact Scale (MFIS) is a self-assessment,values fatigue on daily life impact. Provides 21 items with 5-point Likert scale answer (from 0 = never to 4 = almost always).Total score ranges from 0 to 84 and includes three subscales:physical,cognitive and psychosocial fatigue (score ranges between 0-8)
Measured: Change from baseline in MFIS score at two months + one week
Secondary outcomes (5)
Quality of life
Includes 54 items which generate 12 subscales with two summary scores, and two additional measures given by the single item.
Measured: month 2;month 3;month 6
Stress
It consists of 15 items and breaks down into five areas of evaluation which, when added, quantify the stress response: anxiety, depression, somatization, aggression, social support
Measured: month 2;follow-up (month 3;month 6)
Insomnia
Consists of 7 items answered on a 4-point Likert scales, refers to the Mental Disorders Manual DSM-IV criteria for insomnia, and assesses the Individual impact of the symptoms in the last 2 weeks
Measured: month 2
Physiological parameters and Neurological evaluation
The EDSS is the most widely used to assess neurological disability with a score between 0 and 10
Measured: month 2,month 3;month 6
Cognitive screening
Symbol Digit Modalities Test. Points 0-120. The California Verbal Learning Test - Second Edition. Points: 0-16 Visuospatial Memory Test - Revised. It takes 15 minutes. Points 0-36
Measured: baseline,month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290990
- Sponsor's protocol ID
- DIMMI SI
- Acronym
- DIMMISI
- Status last verified
- Mar 2017
- First submitted
- 7 Oct 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sgoifo A, Bignamini A, La Mantia L, Celani MG, Parietti P, Ceriani MA, Marazzi MR, Proserpio P, Nobili L, Protti A, Agostoni EC. Integrated Imaginative Distention Therapy to Cope with Fatigue. DIMMI SI Study: The First Randomized Controlled Trial in Multiple Sclerosis. Neurol Ther. 2017 Dec;6(2):213-223. doi: 10.1007/s40120-017-0081-9. Epub 2017 Aug 9.
PubMed 28795383
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02290990
- Acronym / sponsor ID
- DIMMISI / DIMMI SI
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis patients | Experimental | Behavioral: "Imaginative Distention" techniquePatients with MS |
| Insomnia patients | Experimental | Behavioral: "Imaginative Distention" techniquePatients with insomnia |
| Health professionists | Experimental | Behavioral: "Imaginative Distention" techniqueHealth professionists as healthy volunteers |
| Waiting list MS | Active comparator | Behavioral: "Imaginative Distention" techniquepw MS filled the self administered questionnaire but they receive any training. They must wait study conclusion to be treated |
| Waiting list arm Insomnia | Active comparator | Behavioral: "Imaginative Distention" techniquepw INS Insomnia Subject filled the self administered questionnaire but they receive any training. They must wait study conclusion to be treated |
| Waiting list arm Health professionists | Active comparator | Behavioral: "Imaginative Distention" techniqueHealth professionist filled the self administered questionnaire but they receive any training. They must wait study conclusion to be treated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
- Diagnosis according to the criteria of Polman, 2011: relapsing remitting or progressive (primary and secondary)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Imaginative Distention" techniqueID 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). | Behavioural | Health professionists, Insomnia patients, Multiple Sclerosis patients, Waiting list MS, Waiting list arm Health professionists, Waiting list arm Insomnia |
Primary outcome
Fatigue
Time frame: Change from baseline in MFIS score at two months + one week
Evaluated with MFIS self administered questionnaire.Modified Fatigue Impact Scale (MFIS) is a self-assessment,values fatigue on daily life impact. Provides 21 items with 5-point Likert scale answer (from 0 = never to 4 = almost always).Total score ranges from 0 to 84 and includes three subscales:physical,cognitive and psychosocial fatigue (score ranges between 0-8)
5 secondary outcomes
Quality of life
Time frame: month 2;month 3;month 6
Stress
Time frame: month 2;follow-up (month 3;month 6)
Insomnia
Time frame: month 2
Physiological parameters and Neurological evaluation
Time frame: month 2,month 3;month 6
Cognitive screening
Time frame: baseline,month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Derived from this study: PubMed 28795383Sgoifo A, Bignamini A, La Mantia L, Celani MG, Parietti P, Ceriani MA, Marazzi MR, Proserpio P, Nobili L, Protti A, Agostoni EC. Integrated Imaginative Distention Therapy to Cope with Fatigue. DIMMI SI Study: The First Randomized Controlled Trial in Multiple Sclerosis. Neurol Ther. 2017 Dec;6(2):213-223. doi: 10.1007/s40120-017-0081-9. Epub 2017 Aug 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Imaginative Distention" technique in people with Multiple Sclerosis, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Change from baseline in MFIS score at two months + one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02290990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.