Evidence map›Paper›PMID 32122315›Full record

ArticleBMC psychiatry2020

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.

Vladimir Carli, Danuta Wasserman, Gergö Hadlaczky, Nuhamin Gebrewold Petros, Sara Carletto, Luca Citi, Sergio Dinis, Claudio Gentili, Sergio Gonzalez-Martinez, Aldo De Leonibus and 11 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC psychiatry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Vladimir CarliNational Centre for Suicide Research and Prevention of Mental Ill-Health, Karolinska Institutet, Stockholm, Sweden. Vladimir.carli@ki.se.
Danuta WassermanNational Centre for Suicide Research and Prevention of Mental Ill-Health, Karolinska Institutet, Stockholm, Sweden.
Gergö HadlaczkyNational Centre for Suicide Research and Prevention of Mental Ill-Health, Karolinska Institutet, Stockholm, Sweden.
Nuhamin Gebrewold PetrosNational Centre for Suicide Research and Prevention of Mental Ill-Health, Karolinska Institutet, Stockholm, Sweden.
Sara CarlettoDepartment of Neuroscience "Rita Levi Montalcini", Università degli Studi di Torino, Turin, Italy.
Luca CitiSchool of Computer Science and Electronic Engineering, University of Essex, Colchester, UK.
Sergio DinisFaculdade de Medicina and CCUL, Universidade de Lisboa, Lisbon, Portugal.
Claudio GentiliGeneral Psychology Department, Università degli Studi di Padova, Padua, Italy.
Sergio Gonzalez-MartinezLife Supporting Technologies, Universidad Politécnica de Madrid, Madrid, Spain.
Aldo De LeonibusInventya LTD, Daresbury, UK.
Björn MeyerGAIA AG, Hamburg, Germany.
Luca OstacoliDepartment of Clinical and Biological Sciences, Università degli studi di Torino, Turin, Italy.
Manuel OttavianoLife Supporting Technologies, Universidad Politécnica de Madrid, Madrid, Spain.
Silvia OuakininFaculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.
Rita ParadisoSmartex, Pisa, Italy.
Riccardo PoliSchool of Computer Science and Electronic Engineering, University of Essex, Colchester, UK.
Isabel RochaFaculdade de Medicina and CCUL, Universidade de Lisboa, Lisbon, Portugal.
Carmen SettantaDepartment of Clinical and Biological Sciences, Università degli studi di Torino, Turin, Italy.
Maria Teresa Arredondo WaldmeyerLife Supporting Technologies, Universidad Politécnica de Madrid, Madrid, Spain.
Gaetano ValenzaResearch Center "E.Piaggio" and Department of Information Engineering, School of Engineering, University of Pisa, Pisa, Italy.
Enzo Pasquale ScilingoResearch Center "E.Piaggio" and Department of Information Engineering, School of Engineering, University of Pisa, Pisa, Italy.

Funding

Horizon 2020 689691
6 · The paper itself

Abstract

backgroundDepressive 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.

methodsThe 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 registrationDRKS00013391. Registered 23 November 2017.

Indexed as

DepressionQuality of LifeCost-Benefit AnalysisHealth ServicesHumansMaleMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicTreatment OutcomeDepressioneHealthEvaluationHorizon 2020InterventionNevermindPatientsPreventionQuality of lifeRCTSomatic conditionTreatment

Identifiers

PMID32122315
PMCPMC7053064

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.