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

Vladimir Carli; Nuhamin Gebrewold Petros; Gergö Hadlaczky; Tereza Vitcheva; Paola Berchialla; Silvia Bianchi; Sara Carletto; Eirini Christinaki; Luca Citi; Sérgio Dinis; Claudio Gentili; Vera Geraldes; Lorena Giovinazzo; Sergio Gonzalez-Martinez; Björn Meyer; Luca Ostacoli; Manuel Ottaviano; Silvia Ouakinin; Tasos Papastylianou; Rita Paradiso; Riccardo Poli; Isabel Rocha; Carmen Settanta; Enzo Pasquale Scilingo; Gaetano Valenza

doi:10.1016/j.eclinm.2022.101423

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

EClinicalMedicine. 2022 May 6:48:101423. doi: 10.1016/j.eclinm.2022.101423. eCollection 2022 Jun.

Authors

Vladimir Carli¹, Nuhamin Gebrewold Petros¹, Gergö Hadlaczky¹, Tereza Vitcheva¹, Paola Berchialla², Silvia Bianchi³, Sara Carletto⁴, Eirini Christinaki⁵, Luca Citi⁵, Sérgio Dinis⁶, Claudio Gentili⁷, Vera Geraldes⁶, Lorena Giovinazzo², Sergio Gonzalez-Martinez⁸, Björn Meyer⁹, Luca Ostacoli², Manuel Ottaviano⁸, Silvia Ouakinin¹⁰, Tasos Papastylianou⁵, Rita Paradiso¹¹, Riccardo Poli⁵, Isabel Rocha⁶, Carmen Settanta², Enzo Pasquale Scilingo³, Gaetano Valenza³

Affiliations

¹ National Centre for Suicide Research and Prevention of Mental Ill-Health, Karolinska Institutet, Stockholm, Sweden.
² Department of Clinical and Biological Sciences, Università degli Studi di Torino, Turin, Italy.
³ Research Center "E.Piaggio" and Department of Information Engineering, School of Engineering, Università di Pisa, Pisa, Italy.
⁴ Department of Neuroscience "Rita Levi Montalcini", Università degli Studi di Torino, Turin, Italy.
⁵ School of Computer Science and Electronic Engineering, University of Essex, Colchester, UK.
⁶ Faculdade de Medicina and CCUL, Universidade de Lisboa, Lisbon, Portugal.
⁷ General Psychology Department, Università degli Studi di Padova, Padua, Italy.
⁸ Life Supporting Technologies, Universidad Politécnica de Madrid, Madrid, Spain.
⁹ GAIA AG, Hamburg, Germany.
¹⁰ Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.
¹¹ Smartex, Pisa, Italy.

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.

Keywords: Depression; Mental health; NEVERMIND; RCT; Somatic conditions; e-health.