A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions
| Autor(a) principal: | |
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| Data de Publicação: | 2020 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
| Texto Completo: | http://hdl.handle.net/10451/42638 |
Resumo: | © The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
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A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditionsDepressionRCTPreventionTreatmenteHealthInterventionEvaluationSomatic conditionQuality of lifePatientsNevermindHorizon 2020© The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Background: Depressive symptoms are common in individuals suffering from severe somatic conditions. There is a lack of interventions and evidence-based interventions aiming to reduce depressive symptoms in patients with severe somatic conditions. The aim of the NEVERMIND project is to address these issues and provide evidence by testing the NEVERMIND system, designed to reduce and prevent depressive symptoms in comparison to treatment as usual. Methods: The NEVERMIND study is a parallel-groups, pragmatic randomised controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The NEVERMIND system comprises a smart shirt and a user interface, in the form of a mobile application. The system is a real-time decision support system, aiming to predict the severity and onset of depressive symptoms by modelling the well-being condition of patients based on physiological data, body movement, and the recurrence of social interactions. The study includes 330 patients who have a diagnosis of myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants are randomised in blocks of ten to either the NEVERMIND intervention or treatment as usual as the control group. Clinical interviews and structured questionnaires are administered at baseline, at 12 weeks, and 24 weeks to assess whether the NEVERMIND system is superior to treatment as usual. The endpoint of primary interest is Beck Depression Inventory II (BDI-II) at 12 weeks defined as (i) the severity of depressive symptoms as measured by the BDI-II. Secondary outcomes include prevention of the onset of depressive symptoms, changes in quality of life, perceived stigma, and self-efficacy. Discussion: There is a lack of evidence-based interventions aiming to reduce and prevent depressive symptoms in patients with severe somatic conditions. If the NEVERMIND system is effective, it will provide healthcare systems with a novel and innovative method to attend to depressive symptoms in patients with severe somatic conditions.The NEVERMIND project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 689691. The funding body had no role in the design of the study and collection as well as in writing the manuscript. Open access funding provided by Karolinska Institute.BMCRepositório da Universidade de LisboaCarli, VladimirWasserman, DanutaHadlaczky, GergöPetros, Nuhamin GebrewoldCarletto, SaraCiti, LucaDinis, SergioGentili, ClaudioGonzalez-Martinez, SergioLeonibus, Aldo DeMeyer, BjörnOstacoli, LucaOttaviano, ManuelOuakinin, SilviaParadiso, RitaPoli, RiccardoRocha, IsabelSettanta, CarmenWaldmeyer, Maria Teresa ArredondoValenza, GaetanoScilingo, Enzo Pasquale2020-03-27T16:22:23Z20202020-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/42638engBMC Psychiatry 20, 93 (2020).1471-244X10.1186/s12888-020-02494-3info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-11-08T16:42:42Zoai:repositorio.ul.pt:10451/42638Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:55:36.683423Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
| dc.title.none.fl_str_mv |
A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions |
| title |
A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions |
| spellingShingle |
A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions Carli, Vladimir Depression RCT Prevention Treatment eHealth Intervention Evaluation Somatic condition Quality of life Patients Nevermind Horizon 2020 |
| title_short |
A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions |
| title_full |
A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions |
| title_fullStr |
A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions |
| title_full_unstemmed |
A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions |
| title_sort |
A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions |
| author |
Carli, Vladimir |
| author_facet |
Carli, Vladimir Wasserman, Danuta Hadlaczky, Gergö Petros, Nuhamin Gebrewold Carletto, Sara Citi, Luca Dinis, Sergio Gentili, Claudio Gonzalez-Martinez, Sergio Leonibus, Aldo De Meyer, Björn Ostacoli, Luca Ottaviano, Manuel Ouakinin, Silvia Paradiso, Rita Poli, Riccardo Rocha, Isabel Settanta, Carmen Waldmeyer, Maria Teresa Arredondo Valenza, Gaetano Scilingo, Enzo Pasquale |
| author_role |
author |
| author2 |
Wasserman, Danuta Hadlaczky, Gergö Petros, Nuhamin Gebrewold Carletto, Sara Citi, Luca Dinis, Sergio Gentili, Claudio Gonzalez-Martinez, Sergio Leonibus, Aldo De Meyer, Björn Ostacoli, Luca Ottaviano, Manuel Ouakinin, Silvia Paradiso, Rita Poli, Riccardo Rocha, Isabel Settanta, Carmen Waldmeyer, Maria Teresa Arredondo Valenza, Gaetano Scilingo, Enzo Pasquale |
| author2_role |
author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Repositório da Universidade de Lisboa |
| dc.contributor.author.fl_str_mv |
Carli, Vladimir Wasserman, Danuta Hadlaczky, Gergö Petros, Nuhamin Gebrewold Carletto, Sara Citi, Luca Dinis, Sergio Gentili, Claudio Gonzalez-Martinez, Sergio Leonibus, Aldo De Meyer, Björn Ostacoli, Luca Ottaviano, Manuel Ouakinin, Silvia Paradiso, Rita Poli, Riccardo Rocha, Isabel Settanta, Carmen Waldmeyer, Maria Teresa Arredondo Valenza, Gaetano Scilingo, Enzo Pasquale |
| dc.subject.por.fl_str_mv |
Depression RCT Prevention Treatment eHealth Intervention Evaluation Somatic condition Quality of life Patients Nevermind Horizon 2020 |
| topic |
Depression RCT Prevention Treatment eHealth Intervention Evaluation Somatic condition Quality of life Patients Nevermind Horizon 2020 |
| description |
© The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
| publishDate |
2020 |
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2020-03-27T16:22:23Z 2020 2020-01-01T00:00:00Z |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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publishedVersion |
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http://hdl.handle.net/10451/42638 |
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http://hdl.handle.net/10451/42638 |
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eng |
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eng |
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BMC Psychiatry 20, 93 (2020). 1471-244X 10.1186/s12888-020-02494-3 |
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