Integrated Imaginative Distention Therapy to Cope with Fatigue. DIMMI SI Study: The First Randomized Controlled Trial in Multiple Sclerosis
Identifieur interne : 000000 ( Pmc/Checkpoint ); suivant : 000001Integrated Imaginative Distention Therapy to Cope with Fatigue. DIMMI SI Study: The First Randomized Controlled Trial in Multiple Sclerosis
Auteurs : Annalisa Sgoifo [Italie] ; Angelo Bignamini [Italie] ; Loredana La Mantia [Italie] ; Maria G. Celani [Italie] ; Piero Parietti [Italie] ; Maria A. Ceriani [Italie] ; Maria R. Marazzi [Italie] ; Paola Proserpio [Italie] ; Lino Nobili [Italie] ; Alessandra Protti [Italie] ; Elio C. Agostoni [Italie]Source :
- Neurology and Therapy [ 2193-8253 ] ; 2017.
Abstract
Fatigue is a frequent, disabling, and difficult to treat symptom in neurological disease and in other stress-related conditions; Integrated Imaginative Distention (IID) is a therapy combining muscular and imaginative relaxation, feasible also in disabled subjects; the DIMMI SI trial was planned to evaluate IID efficacy on fatigue.
The design was a parallel, randomised 1:1 (intervention:waiting list), controlled, open-label trial. Participants were persons with multiple sclerosis (pwMS), persons with insomnia (pwINS), and health professionals (HP) as conditions related to fatigue and stress. The primary outcome was the post-intervention change of fatigue; secondary outcomes were changes in insomnia, stress, and quality of life (QoL). Eight IID weekly training group sessions were delivered by a skilled psychotherapist. The study lasted 12 months.
One hundred and forty-four subjects were enrolled, 48 for each condition. The mean change in Modified Fatigue Impact Scale (MFIS) score among exposed was 7.7 [95% CI 1.1, 14.4] (
DIMMI SI is the first randomized controlled trial evaluating the efficacy of IID on fatigue. IID resulted a complementary intervention to reduce fatigue in stress-related conditions, in both health and disease status. NCT02290990ClinicalTrials.gov.
The online version of this article (doi:10.1007/s40120-017-0081-9) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1007/s40120-017-0081-9
PubMed: 28795383
PubMed Central: 5700903
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Marazzi</name><affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="GRID">grid.416200.1</institution-id><institution>Multiple Sclerosis Centre, Department of Neurosciences,</institution><institution>ASST Niguarda Hospital,</institution></institution-wrap>Piazza Ospedale Maggiore, 3, 20162 Milan, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Piazza Ospedale Maggiore, 3, 20162 Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Proserpio, Paola" sort="Proserpio, Paola" uniqKey="Proserpio P" first="Paola" last="Proserpio">Paola Proserpio</name><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="GRID">grid.416200.1</institution-id><institution>Sleep Disorders Center and Claudio Munari Neurosurgery Epilepsy Center,</institution><institution>ASST Niguarda Hospital,</institution></institution-wrap>Piazza Ospedale Maggiore, 3, 20162 Milan, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Piazza Ospedale Maggiore, 3, 20162 Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Nobili, Lino" sort="Nobili, Lino" uniqKey="Nobili L" first="Lino" last="Nobili">Lino Nobili</name><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="GRID">grid.416200.1</institution-id><institution>Sleep Disorders Center and Claudio Munari Neurosurgery Epilepsy Center,</institution><institution>ASST Niguarda Hospital,</institution></institution-wrap>Piazza Ospedale Maggiore, 3, 20162 Milan, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Piazza Ospedale Maggiore, 3, 20162 Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Protti, Alessandra" sort="Protti, Alessandra" uniqKey="Protti A" first="Alessandra" last="Protti">Alessandra Protti</name><affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="GRID">grid.416200.1</institution-id><institution>Multiple Sclerosis Centre, Department of Neurosciences,</institution><institution>ASST Niguarda Hospital,</institution></institution-wrap>Piazza Ospedale Maggiore, 3, 20162 Milan, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Piazza Ospedale Maggiore, 3, 20162 Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Agostoni, Elio C" sort="Agostoni, Elio C" uniqKey="Agostoni E" first="Elio C." last="Agostoni">Elio C. Agostoni</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.416200.1</institution-id><institution>Department of Neurosciences,</institution><institution>ASST Niguarda Hospital,</institution></institution-wrap>Piazza Ospedale Maggiore, 3, 20162 Milan, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Piazza Ospedale Maggiore, 3, 20162 Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author></analytic><series><title level="j">Neurology and Therapy</title><idno type="ISSN">2193-8253</idno><idno type="eISSN">2193-6536</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Introduction</title><p id="Par1">Fatigue is a frequent, disabling, and difficult to treat symptom in neurological disease and in other stress-related conditions; Integrated Imaginative Distention (IID) is a therapy combining muscular and imaginative relaxation, feasible also in disabled subjects; the DIMMI SI trial was planned to evaluate IID efficacy on fatigue.</p></sec><sec><title>Methods</title><p id="Par2">The design was a parallel, randomised 1:1 (intervention:waiting list), controlled, open-label trial. Participants were persons with multiple sclerosis (pwMS), persons with insomnia (pwINS), and health professionals (HP) as conditions related to fatigue and stress. The primary outcome was the post-intervention change of fatigue; secondary outcomes were changes in insomnia, stress, and quality of life (QoL). Eight IID weekly training group sessions were delivered by a skilled psychotherapist. The study lasted 12 months.</p></sec><sec><title>Results</title><p id="Par3">One hundred and forty-four subjects were enrolled, 48 for each condition. The mean change in Modified Fatigue Impact Scale (MFIS) score among exposed was 7.7 [95% CI 1.1, 14.4] (<italic>P</italic> = 0.023) in pwMS; 7.1 [1.9, 12.3] (<italic>P</italic> = 0.007) among pwINS, and 11.3 [4.3, 18.2] among HP (<italic>P</italic> = 0.002). At the last follow-up, the benefit was confirmed on physical fatigue for pwMS, on total fatigue for pwINS and HP.</p></sec><sec><title>Conclusions</title><p id="Par4">DIMMI SI is the first randomized controlled trial evaluating the efficacy of IID on fatigue. IID resulted a complementary intervention to reduce fatigue in stress-related conditions, in both health and disease status. NCT02290990ClinicalTrials.gov.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1007/s40120-017-0081-9) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Giovannoni, G" uniqKey="Giovannoni G">G Giovannoni</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kluger, Bm" uniqKey="Kluger B">BM Kluger</name></author><author><name sortKey="Krupp, Lb" uniqKey="Krupp L">LB Krupp</name></author><author><name sortKey="Enoka, Rm" uniqKey="Enoka R">RM Enoka</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chaudhuri, A" uniqKey="Chaudhuri A">A Chaudhuri</name></author><author><name sortKey="Behan, Bo" uniqKey="Behan B">BO Behan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Veauthier, C" uniqKey="Veauthier 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Neurol Ther</journal-id><journal-id journal-id-type="iso-abbrev">Neurol Ther</journal-id><journal-title-group><journal-title>Neurology and Therapy</journal-title></journal-title-group><issn pub-type="ppub">2193-8253</issn><issn pub-type="epub">2193-6536</issn><publisher><publisher-name>Springer Healthcare</publisher-name><publisher-loc>Cheshire</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">28795383</article-id><article-id pub-id-type="pmc">5700903</article-id><article-id pub-id-type="publisher-id">81</article-id><article-id pub-id-type="doi">10.1007/s40120-017-0081-9</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Research</subject></subj-group></article-categories><title-group><article-title>Integrated Imaginative Distention Therapy to Cope with Fatigue. DIMMI SI Study: The First Randomized Controlled Trial in Multiple Sclerosis</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0001-9603-3883</contrib-id><name><surname>Sgoifo</surname><given-names>Annalisa</given-names></name><address><email>annalisa.sgoifo@ospedaleniguarda.it</email></address><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Bignamini</surname><given-names>Angelo</given-names></name><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>La Mantia</surname><given-names>Loredana</given-names></name><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Celani</surname><given-names>Maria G.</given-names></name><xref ref-type="aff" rid="Aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Parietti</surname><given-names>Piero</given-names></name><xref ref-type="aff" rid="Aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Ceriani</surname><given-names>Maria A.</given-names></name><xref ref-type="aff" rid="Aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Marazzi</surname><given-names>Maria R.</given-names></name><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Proserpio</surname><given-names>Paola</given-names></name><xref ref-type="aff" rid="Aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Nobili</surname><given-names>Lino</given-names></name><xref ref-type="aff" rid="Aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Protti</surname><given-names>Alessandra</given-names></name><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Agostoni</surname><given-names>Elio C.</given-names></name><xref ref-type="aff" rid="Aff1">1</xref></contrib><aff id="Aff1"><label>1</label><institution-wrap><institution-id institution-id-type="GRID">grid.416200.1</institution-id><institution>Department of Neurosciences,</institution><institution>ASST Niguarda Hospital,</institution></institution-wrap>Piazza Ospedale Maggiore, 3, 20162 Milan, Italy</aff><aff id="Aff2"><label>2</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1757 2822</institution-id><institution-id institution-id-type="GRID">grid.4708.b</institution-id><institution>Department of Pharmaceutical Sciences, School of Specialization in Hospital Pharmacy,</institution><institution>University of Milan,</institution></institution-wrap>Milan, Italy</aff><aff id="Aff3"><label>3</label><institution-wrap><institution-id institution-id-type="GRID">grid.416200.1</institution-id><institution>Multiple Sclerosis Centre, Department of Neurosciences,</institution><institution>ASST Niguarda Hospital,</institution></institution-wrap>Piazza Ospedale Maggiore, 3, 20162 Milan, Italy</aff><aff id="Aff4"><label>4</label>UOC Neurophysiopathology Division, A.O. Perugia, Perugia, Italy</aff><aff id="Aff5"><label>5</label>H. Bernheim Institute, Verona, Italy</aff><aff id="Aff6"><label>6</label>Italian Society of Psychosomatics Medicine, Milan, Italy</aff><aff id="Aff7"><label>7</label><institution-wrap><institution-id institution-id-type="GRID">grid.416200.1</institution-id><institution>Sleep Disorders Center and Claudio Munari Neurosurgery Epilepsy Center,</institution><institution>ASST Niguarda Hospital,</institution></institution-wrap>Piazza Ospedale Maggiore, 3, 20162 Milan, Italy</aff></contrib-group><pub-date pub-type="epub"><day>9</day><month>8</month><year>2017</year></pub-date><pub-date pub-type="pmc-release"><day>9</day><month>8</month><year>2017</year></pub-date><pub-date pub-type="collection"><month>12</month><year>2017</year></pub-date><volume>6</volume><issue>2</issue><fpage>213</fpage><lpage>223</lpage><history><date date-type="received"><day>19</day><month>6</month><year>2017</year></date></history><permissions><copyright-statement>© The Author(s) 2017</copyright-statement></permissions><abstract id="Abs1"><sec><title>Introduction</title><p id="Par1">Fatigue is a frequent, disabling, and difficult to treat symptom in neurological disease and in other stress-related conditions; Integrated Imaginative Distention (IID) is a therapy combining muscular and imaginative relaxation, feasible also in disabled subjects; the DIMMI SI trial was planned to evaluate IID efficacy on fatigue.</p></sec><sec><title>Methods</title><p id="Par2">The design was a parallel, randomised 1:1 (intervention:waiting list), controlled, open-label trial. Participants were persons with multiple sclerosis (pwMS), persons with insomnia (pwINS), and health professionals (HP) as conditions related to fatigue and stress. The primary outcome was the post-intervention change of fatigue; secondary outcomes were changes in insomnia, stress, and quality of life (QoL). Eight IID weekly training group sessions were delivered by a skilled psychotherapist. The study lasted 12 months.</p></sec><sec><title>Results</title><p id="Par3">One hundred and forty-four subjects were enrolled, 48 for each condition. The mean change in Modified Fatigue Impact Scale (MFIS) score among exposed was 7.7 [95% CI 1.1, 14.4] (<italic>P</italic> = 0.023) in pwMS; 7.1 [1.9, 12.3] (<italic>P</italic> = 0.007) among pwINS, and 11.3 [4.3, 18.2] among HP (<italic>P</italic> = 0.002). At the last follow-up, the benefit was confirmed on physical fatigue for pwMS, on total fatigue for pwINS and HP.</p></sec><sec><title>Conclusions</title><p id="Par4">DIMMI SI is the first randomized controlled trial evaluating the efficacy of IID on fatigue. IID resulted a complementary intervention to reduce fatigue in stress-related conditions, in both health and disease status. NCT02290990ClinicalTrials.gov.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1007/s40120-017-0081-9) contains supplementary material, which is available to authorized users.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Behaviour/addiction</kwd><kwd>Multiple sclerosis and other demyelinating diseases</kwd><kwd>Sleep disorders</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© Springer Healthcare Ltd., part of Springer Nature 2017</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc><affiliations><list><country><li>Italie</li></country><region><li>Lombardie</li></region><settlement><li>Milan</li></settlement></list><tree><country name="Italie"><region name="Lombardie"><name sortKey="Sgoifo, Annalisa" sort="Sgoifo, Annalisa" uniqKey="Sgoifo A" first="Annalisa" last="Sgoifo">Annalisa Sgoifo</name></region><name sortKey="Agostoni, Elio C" sort="Agostoni, Elio C" uniqKey="Agostoni E" first="Elio C." last="Agostoni">Elio C. Agostoni</name><name sortKey="Bignamini, Angelo" sort="Bignamini, Angelo" uniqKey="Bignamini A" first="Angelo" last="Bignamini">Angelo Bignamini</name><name sortKey="Celani, Maria G" sort="Celani, Maria G" uniqKey="Celani M" first="Maria G." last="Celani">Maria G. Celani</name><name sortKey="Ceriani, Maria A" sort="Ceriani, Maria A" uniqKey="Ceriani M" first="Maria A." last="Ceriani">Maria A. Ceriani</name><name sortKey="La Mantia, Loredana" sort="La Mantia, Loredana" uniqKey="La Mantia L" first="Loredana" last="La Mantia">Loredana La Mantia</name><name sortKey="Marazzi, Maria R" sort="Marazzi, Maria R" uniqKey="Marazzi M" first="Maria R." last="Marazzi">Maria R. Marazzi</name><name sortKey="Nobili, Lino" sort="Nobili, Lino" uniqKey="Nobili L" first="Lino" last="Nobili">Lino Nobili</name><name sortKey="Parietti, Piero" sort="Parietti, Piero" uniqKey="Parietti P" first="Piero" last="Parietti">Piero Parietti</name><name sortKey="Proserpio, Paola" sort="Proserpio, Paola" uniqKey="Proserpio P" first="Paola" last="Proserpio">Paola Proserpio</name><name sortKey="Protti, Alessandra" sort="Protti, Alessandra" uniqKey="Protti A" first="Alessandra" last="Protti">Alessandra Protti</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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