WELL.ME - Wellbeing therapy based on real-time personalized mobile architecture, vs. cognitive therapy, to reduce psychological distress and promote healthy lifestyle in cardiovascular disease patients: study protocol for a randomized controlled trial
Identifieur interne : 000846 ( Main/Exploration ); précédent : 000845; suivant : 000847WELL.ME - Wellbeing therapy based on real-time personalized mobile architecture, vs. cognitive therapy, to reduce psychological distress and promote healthy lifestyle in cardiovascular disease patients: study protocol for a randomized controlled trial
Auteurs : Angelo Compare [Italie] ; Vassilis Kouloulias [Grèce] ; Vontas Apostolos [Grèce] ; Wendy Moreno Pe A [Espagne] ; Enrico Molinari [Italie] ; Enzo Grossi [Italie] ; Efstathopoulos Efstathios [Grèce] ; Michele Carenini [Italie]Source :
- Trials [ 1745-6215 ] ; 2012.
Abstract
There is compelling evidence that psychological factors may have the same or even greater impact on the possibility of adverse events on cardiac diseases (CD) than other traditional clinical risk factors. Anxiety and depression are predictors of short- and long-term adverse outcomes, increased risk for higher rates of in-hospital complications, re-infarction, malignant arrhythmias, and mortality in CD patients. Despite researchers finding that cognitive behavior therapy (CBT) reduced depressive and anxiety symptoms, the fact that such results are maintained only in the short term and the lack of maintenance of the long-term affects the absence of changes in lifestyles, preventing the possibility of a wide generalization of results. Recently wellbeing therapy (WBT) has been proposed as a useful approach to improve healthy lifestyle behaviors and reduce psychological distress.
The present randomized controlled study will test WBT, in comparison with CBT, as far as the reduction of symptoms of depression, anxiety and psychological distress, and the improvement of lifestyle behaviors and quality of life in cardiac patients are concerned. Moreover, innovations in communication technologies allow patients to be constantly followed in real life. Therefore WBT based on personalized mobile technology will allow the testing of its effectiveness in comparison with usual WBT.
The present study is a large outpatient study on the treatment of co-morbid depression, anxiety, and psychological distress in cardiac patients. The most important issues of this study are its randomized design, the focus on promotion of health-related behaviors, and the use of innovative technologies supporting patients’ wellbeing in real life and in a continuous way. First results are expected in 2012.
ClinicalTrials.gov Identifier: NCT01543815.
Url:
DOI: 10.1186/1745-6215-13-157
PubMed: 22943627
PubMed Central: 3492018
Affiliations:
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Dept. of Human and Social Sciences, University of Bergamo, Piazzale S. Agostino 2, 24129, Bergamo, BG, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Human Factors and Technologies for Health - HTC Centre; Dept. of Human and Social Sciences, University of Bergamo, Piazzale S. Agostino 2, 24129, Bergamo, BG</wicri:regionArea><wicri:noRegion>BG</wicri:noRegion></affiliation></author><author><name sortKey="Kouloulias, Vassilis" sort="Kouloulias, Vassilis" uniqKey="Kouloulias V" first="Vassilis" last="Kouloulias">Vassilis Kouloulias</name><affiliation wicri:level="3"><nlm:aff id="I2">Medical School, National University of Athens, Athens, Greece</nlm:aff><country xml:lang="fr">Grèce</country><wicri:regionArea>Medical School, National University of Athens, Athens</wicri:regionArea><placeName><settlement type="city">Athènes</settlement><region nuts="2" type="region">Attique (région)</region></placeName></affiliation></author><author><name sortKey="Apostolos, Vontas" sort="Apostolos, Vontas" uniqKey="Apostolos V" first="Vontas" last="Apostolos">Vontas Apostolos</name><affiliation wicri:level="1"><nlm:aff id="I3">Technopolis ICT Business Park, Thessaloniki, Greece</nlm:aff><country xml:lang="fr">Grèce</country><wicri:regionArea>Technopolis ICT Business Park, Thessaloniki</wicri:regionArea><wicri:noRegion>Thessaloniki</wicri:noRegion></affiliation></author><author><name sortKey="Pe A, Wendy Moreno" sort="Pe A, Wendy Moreno" uniqKey="Pe A W" first="Wendy Moreno" last="Pe A">Wendy Moreno Pe A</name><affiliation wicri:level="1"><nlm:aff id="I4">SOROS GABINETE, Socia ProgramasEuropeos, Europe, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>SOROS GABINETE, Socia ProgramasEuropeos, Europe</wicri:regionArea><wicri:noRegion>Europe</wicri:noRegion></affiliation></author><author><name sortKey="Molinari, Enrico" sort="Molinari, Enrico" uniqKey="Molinari E" first="Enrico" last="Molinari">Enrico Molinari</name><affiliation wicri:level="3"><nlm:aff id="I5">Istituto Auxologico Italiano; Catholic University of Milan, Milan, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Istituto Auxologico Italiano; Catholic University of Milan, Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Grossi, Enzo" sort="Grossi, Enzo" uniqKey="Grossi E" first="Enzo" last="Grossi">Enzo Grossi</name><affiliation wicri:level="3"><nlm:aff id="I6">Medical Department, Bracco SpA; IULM - University, Fondazione Bracco, Milan, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Medical Department, Bracco SpA; IULM - University, Fondazione Bracco, Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Efstathios, Efstathopoulos" sort="Efstathios, Efstathopoulos" uniqKey="Efstathios E" first="Efstathopoulos" last="Efstathios">Efstathopoulos Efstathios</name><affiliation wicri:level="3"><nlm:aff id="I2">Medical School, National University of Athens, Athens, Greece</nlm:aff><country xml:lang="fr">Grèce</country><wicri:regionArea>Medical School, National University of Athens, Athens</wicri:regionArea><placeName><settlement type="city">Athènes</settlement><region nuts="2" type="region">Attique (région)</region></placeName></affiliation></author><author><name sortKey="Carenini, Michele" sort="Carenini, Michele" uniqKey="Carenini M" first="Michele" last="Carenini">Michele Carenini</name><affiliation wicri:level="1"><nlm:aff id="I7">NoemaLife Spa, Bologna, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>NoemaLife Spa, Bologna</wicri:regionArea><wicri:noRegion>Bologna</wicri:noRegion></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>There is compelling evidence that psychological factors may have the same or even greater impact on the possibility of adverse events on cardiac diseases (CD) than other traditional clinical risk factors. Anxiety and depression are predictors of short- and long-term adverse outcomes, increased risk for higher rates of in-hospital complications, re-infarction, malignant arrhythmias, and mortality in CD patients. Despite researchers finding that cognitive behavior therapy (CBT) reduced depressive and anxiety symptoms, the fact that such results are maintained only in the short term and the lack of maintenance of the long-term affects the absence of changes in lifestyles, preventing the possibility of a wide generalization of results. Recently wellbeing therapy (WBT) has been proposed as a useful approach to improve healthy lifestyle behaviors and reduce psychological distress.</p></sec><sec><title>Methods/design</title><p>The present randomized controlled study will test WBT, in comparison with CBT, as far as the reduction of symptoms of depression, anxiety and psychological distress, and the improvement of lifestyle behaviors and quality of life in cardiac patients are concerned. Moreover, innovations in communication technologies allow patients to be constantly followed in real life. Therefore WBT based on personalized mobile technology will allow the testing of its effectiveness in comparison with usual WBT.</p></sec><sec><title>Discussion</title><p>The present study is a large outpatient study on the treatment of co-morbid depression, anxiety, and psychological distress in cardiac patients. The most important issues of this study are its randomized design, the focus on promotion of health-related behaviors, and the use of innovative technologies supporting patients’ wellbeing in real life and in a continuous way. First results are expected in 2012.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov Identifier: NCT01543815.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Kubzansky, Ld" uniqKey="Kubzansky L">LD Kubzansky</name></author><author><name sortKey="Kawachi, I" uniqKey="Kawachi I">I Kawachi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rozanski, A" uniqKey="Rozanski A">A Rozanski</name></author><author><name sortKey="Blumenthal, Ja" uniqKey="Blumenthal J">JA Blumenthal</name></author><author><name sortKey="Kaplan, J" uniqKey="Kaplan J">J Kaplan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Molinari, E" uniqKey="Molinari E">E Molinari</name></author><author><name sortKey="Compare, A" uniqKey="Compare A">A Compare</name></author><author><name sortKey="Parati, G" uniqKey="Parati G">G 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Dupuy</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Grossi, E" uniqKey="Grossi E">E Grossi</name></author><author><name sortKey="Groth, N" uniqKey="Groth N">N Groth</name></author><author><name sortKey="Mosconi, P" uniqKey="Mosconi P">P Mosconi</name></author><author><name sortKey="Cerutti, R" uniqKey="Cerutti R">R Cerutti</name></author><author><name sortKey="Pace, F" uniqKey="Pace F">F Pace</name></author><author><name sortKey="Compare, A" uniqKey="Compare A">A Compare</name></author><author><name sortKey="Apolone, G" uniqKey="Apolone G">G Apolone</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Omvik, P" uniqKey="Omvik P">P Omvik</name></author><author><name sortKey="Thaulow, E" uniqKey="Thaulow E">E Thaulow</name></author><author><name sortKey="Herlan, O" uniqKey="Herlan O">O Herlan</name></author><author><name sortKey="Eide, I" uniqKey="Eide I">I Eide</name></author><author><name sortKey="Midha, R" uniqKey="Midha R">R Midha</name></author><author><name sortKey="Turner, R" uniqKey="Turner R">R Turner</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rector, Ts" uniqKey="Rector T">TS Rector</name></author><author><name sortKey="Cohn, Jn" uniqKey="Cohn J">JN Cohn</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cohen, J" uniqKey="Cohen J">J Cohen</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Espagne</li><li>Grèce</li><li>Italie</li></country><region><li>Attique (région)</li><li>Lombardie</li></region><settlement><li>Athènes</li><li>Milan</li></settlement></list><tree><country name="Italie"><noRegion><name sortKey="Compare, Angelo" sort="Compare, Angelo" uniqKey="Compare A" first="Angelo" last="Compare">Angelo Compare</name></noRegion><name sortKey="Carenini, Michele" sort="Carenini, Michele" uniqKey="Carenini M" first="Michele" last="Carenini">Michele Carenini</name><name sortKey="Grossi, Enzo" sort="Grossi, Enzo" uniqKey="Grossi E" first="Enzo" last="Grossi">Enzo Grossi</name><name sortKey="Molinari, Enrico" sort="Molinari, Enrico" uniqKey="Molinari E" first="Enrico" last="Molinari">Enrico Molinari</name></country><country name="Grèce"><region name="Attique (région)"><name sortKey="Kouloulias, Vassilis" sort="Kouloulias, Vassilis" uniqKey="Kouloulias V" first="Vassilis" last="Kouloulias">Vassilis Kouloulias</name></region><name sortKey="Apostolos, Vontas" sort="Apostolos, Vontas" uniqKey="Apostolos V" first="Vontas" last="Apostolos">Vontas Apostolos</name><name sortKey="Efstathios, Efstathopoulos" sort="Efstathios, Efstathopoulos" uniqKey="Efstathios E" first="Efstathopoulos" last="Efstathios">Efstathopoulos Efstathios</name></country><country name="Espagne"><noRegion><name sortKey="Pe A, Wendy Moreno" sort="Pe A, Wendy Moreno" uniqKey="Pe A W" first="Wendy Moreno" last="Pe A">Wendy Moreno Pe 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