Research Repository

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 and Wasserman, Danuta and Hadlaczky, Gergö and Petros, Nuhamin Gebrewold and Carletto, Sara and Citi, Luca and Dinis, Sergio and Gentili, Claudio and Gonzalez-Martinez, Sergio and De Leonibus, Aldo and Meyer, Björn and Ostacoli, Luca and Ottaviano, Manuel and Ouakinin, Silvia and Paradiso, Rita and Poli, Riccardo and Rocha, Isabel and Settanta, Carmen and Waldmeyer, Maria Teresa Arredondo and Valenza, Gaetano and Scilingo, Enzo Pasquale (2020) '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.' BMC Psychiatry, 20 (1). ISSN 1471-244X

[img]
Preview
Text
A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in prev.pdf - Published Version
Available under License Creative Commons Attribution.

Download (646kB) | Preview

Abstract

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. Trial registration DRKS00013391. Registered 23 November 2017.

Item Type: Article
Divisions: Faculty of Science and Health > Computer Science and Electronic Engineering, School of
Depositing User: Elements
Date Deposited: 07 Oct 2020 15:06
Last Modified: 07 Oct 2020 15:06
URI: http://repository.essex.ac.uk/id/eprint/28837

Actions (login required)

View Item View Item