Integrated Imaginative Distention Therapy to Cope with Fatigue. DIMMI SI Study: The First Randomized Controlled Trial in Multiple Sclerosis
Identifieur interne : 000006 ( Pmc/Curation ); précédent : 000005; suivant : 000007Integrated 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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<series><title level="j">Neurology and Therapy</title>
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<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>
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<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<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>
</record>
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