May 23, 2022
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Article

The NEVERMIND e-health system in the treatment of depressive symptoms among patients with severe somatic conditions: A multicentre, pragmatic randomised controlled trial

Publicated to: EClinicalMedicine. 48 101423- - 2022-06-01 48(), DOI: 10.1016/j.eclinm.2022.101423

Authors:

Carli, V; Petros, NG; Hadlaczky, G; Vitcheva, T; Berchialla, P; Bianchi, S; Carletto, S; Christinaki, E; Citi, L; Dinis, S; Gentili, C; Geraldes, V; Giovinazzo, L; Gonzalez-Martinez, S; Meyer, B; Ostacoli, L; Ottaviano, M; Ouakinin, S; Papastylianou, T; Paradiso, R; Poli, R; Rocha, I; Settanta, C; Scilingo, EP; Valenza, G
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Affiliations

Faculdade de Medicina, Universidade de Lisboa - Author
Gaia AG - Author
GAIA AG, Hamburg, Germany - Author
Karolinska Inst, Natl Ctr Suicide Res & Prevent Mental Ill Hlth, Stockholm, Sweden - Author
Karolinska Institutet - Author
Smartex srl - Author
Smartex, Pisa, Italy - Author
Univ Essex, Sch Comp Sci & Elect Engn, Colchester, Essex, England - Author
Univ Lisbon, CCUL, Lisbon, Portugal - Author
Univ Lisbon, Fac Med, Lisbon, Portugal - Author
Univ Padua, Gen Psychol Dept, Padua, Italy - Author
Univ Pisa, Dept Informat Engn, Sch Engn, Pisa, Italy - Author
Univ Pisa, Res Ctr E Piaggio, Sch Engn, Pisa, Italy - Author
Univ Politecn Madrid, Life Supporting Technol, Madrid, Spain - Author
Univ Torino, Dept Clin & Biol Sci, Turin, Italy - Author
Univ Torino, Dept Neurosci Rita Levi Montalcini, Turin, Italy - Author
Universidad Politécnica de Madrid - Author
Universitá degli Studi di Padova - Author
Università degli Studi di Torino - Author
Università degli Studi di Torino, Scuola di Medicina - Author
Universita di Pisa - Author
University of Essex - Author
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Abstract

Background: This study assessed the effectiveness of the NEVERMIND e-health system, consisting of a smart shirt and a mobile application with lifestyle behavioural advice, mindfulness-based therapy, and cognitive behavioural therapy, in reducing depressive symptoms among patients diagnosed with severe somatic conditions. Our hypothesis was that the system would significantly decrease the level of depressive symptoms in the intervention group compared to the control group. Methods: This pragmatic, randomised controlled trial included 425 patients diagnosed with myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants were recruited from hospitals in Turin and Pisa (Italy), and Lisbon (Portugal), and were randomly assigned to either the NEVERMIND intervention or to the control group. Clinical interviews and structured questionnaires were administered at baseline, 12 weeks, and 24 weeks. The primary outcome was depressive symptoms at 12 weeks measured by the Beck Depression Inventory II (BDI-II). Intention-to-treat analyses included 425 participants, while the per-protocol analyses included 333 participants. This trial is registered in the German Clinical Trials Register, DRKS00013391. Findings: Patients were recruited between Dec 4, 2017, and Dec 31, 2019, with 213 assigned to the intervention and 212 to the control group. The sample had a mean age of 59·41 years (SD=10·70), with 44·24% women. Those who used the NEVERMIND system had statistically significant lower depressive symptoms at the 12-week follow-up (mean difference=-3·03, p<0·001; 95% CI -4·45 to -1·62) compared with controls, with a clinically relevant effect size (Cohen's d=0·39). Interpretation: The results of this study show that the NEVERMIND system is superior to standard care in reducing and preventing depressive symptoms among patients with the studied somatic conditions. Funding: The NEVERMIND project received funding from the European Union's Horizon 2020 Research and Innovation Programme under grant agreement No. 689691.
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Keywords

chronic illnesse-healthinterventionsmental healthnevermindrctsomatic conditionsDepressionE-healthMental healthNevermindQuality-of-lifeRctSomatic conditions

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal EClinicalMedicine due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2022, it was in position 14/169, thus managing to position itself as a Q1 (Primer Cuartil), in the category Medicine, General & Internal. Notably, the journal is positioned above the 90th percentile.

From a relative perspective, and based on the normalized impact indicator calculated from World Citations provided by WoS (ESI, Clarivate), it yields a value for the citation normalization relative to the expected citation rate of: 1.5. This indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: ESI Nov 13, 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2026-04-27, the following number of citations:

  • WoS: 11
  • Scopus: 9
  • Europe PMC: 4
  • Google Scholar: 9
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Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2026-04-27:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 122.

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 4.
  • The number of mentions on the social network X (formerly Twitter): 8 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.
  • Assignment of a Handle/URN as an identifier within the deposit in the Institutional Repository: https://oa.upm.es/94286/

As a result of the publication of the work in the institutional repository, statistical usage data has been obtained that reflects its impact. In terms of dissemination, we can state that, as of

  • Views: 17
  • Downloads: 6
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Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: Germany; Italy; Portugal; Reunion Island; Sweden; United Kingdom.

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