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

Carli, Vladimir and Petros, Nuhamin Gebrewold and Hadlaczky, Gergö and Vitcheva, Tereza and Berchialla, Paola and Bianchi, Silvia and Carletto, Sara and Christinaki, Eirini and Citi, Luca and Dinis, Sérgio and Gentili, Claudio and Geraldes, Vera and Giovinazzo, Lorena and Gonzalez-Martinez, Sergio and Meyer, Björn and Ostacoli, Luca and Ottaviano, Manuel and Ouakinin, Silvia and Papastylianou, Tasos and Paradiso, Rita and Poli, Riccardo and Rocha, Isabel and Settanta, Carmen and Scilingo, Enzo Pasquale and Valenza, Gaetano (2022) 'The NEVERMIND e-health system in the treatment of depressive symptoms among patients with severe somatic conditions: A multicentre, pragmatic randomised controlled trial.' eClinicalMedicine, 48. p. 101423. ISSN 2589-5370

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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.

Item Type: Article
Uncontrolled Keywords: Depression; Mental health; e-health; RCT; Somatic conditions; NEVERMIND
Divisions: Faculty of Science and Health
Faculty of Science and Health > Computer Science and Electronic Engineering, School of
SWORD Depositor: Elements
Depositing User: Elements
Date Deposited: 20 Jun 2022 12:11
Last Modified: 23 Sep 2022 19:53

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