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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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>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\u2009weeks, and 24\u2009weeks 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\u2009weeks 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.drks.de\/drks_web\/navigate.do?navigationId=trial.HTML&amp;TRIAL_ID=DRKS00013391\">DRKS00013391<\/jats:ext-link>. Registered 23 November 2017.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12888-020-02494-3","type":"journal-article","created":{"date-parts":[[2020,3,2]],"date-time":"2020-03-02T14:08:38Z","timestamp":1583158118000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":14,"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"],"prefix":"10.1186","volume":"20","author":[{"given":"Vladimir","family":"Carli","sequence":"first","affiliation":[]},{"given":"Danuta","family":"Wasserman","sequence":"additional","affiliation":[]},{"given":"Gerg\u00f6","family":"Hadlaczky","sequence":"additional","affiliation":[]},{"given":"Nuhamin Gebrewold","family":"Petros","sequence":"additional","affiliation":[]},{"given":"Sara","family":"Carletto","sequence":"additional","affiliation":[]},{"given":"Luca","family":"Citi","sequence":"additional","affiliation":[]},{"given":"Sergio","family":"Dinis","sequence":"additional","affiliation":[]},{"given":"Claudio","family":"Gentili","sequence":"additional","affiliation":[]},{"given":"Sergio","family":"Gonzalez-Martinez","sequence":"additional","affiliation":[]},{"family":"Aldo De Leonibus","sequence":"additional","affiliation":[]},{"given":"Bj\u00f6rn","family":"Meyer","sequence":"additional","affiliation":[]},{"given":"Luca","family":"Ostacoli","sequence":"additional","affiliation":[]},{"given":"Manuel","family":"Ottaviano","sequence":"additional","affiliation":[]},{"given":"Silvia","family":"Ouakinin","sequence":"additional","affiliation":[]},{"given":"Rita","family":"Paradiso","sequence":"additional","affiliation":[]},{"given":"Riccardo","family":"Poli","sequence":"additional","affiliation":[]},{"given":"Isabel","family":"Rocha","sequence":"additional","affiliation":[]},{"given":"Carmen","family":"Settanta","sequence":"additional","affiliation":[]},{"given":"Maria Teresa Arredondo","family":"Waldmeyer","sequence":"additional","affiliation":[]},{"given":"Gaetano","family":"Valenza","sequence":"additional","affiliation":[]},{"given":"Enzo Pasquale","family":"Scilingo","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2020,3,2]]},"reference":[{"key":"2494_CR1","unstructured":"World Health Organisation. 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Ethical approval for the NEVERMIND study was submitted and approved by the following local research ethics committee in each of the countries where the intervention is implemented:\nAny important protocol modifications and amendments will be immediately communicated to all the participating centres as well as the European Commission. Researchers obtain a written informed consent from each subject after explaining all aspects of the study that is relevant for the participant to make his or her decision.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"BM declares that he is employed by Gaia AG, the developer and owner of Deprexis, an internet-based intervention for depression, which is offered selectively to patients within the context of the NEVERMIND system. 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