Mobile therapeutic attention for treatment-resistant schizophrenia (m-RESIST): a prospective multicentre feasibility study protocol in patients and their caregivers

Anna Alonso-Solís, Katya Rubinstein, Iluminada Corripio, Erika Jaaskelainen, Annika Seppälä, Vincenzo Alberto Vella, Johanna Caro-Mendivelso, Asaf Caspi, Matti Isohanni, Zsolt Unoka, Shenja Van der Graff, Kinga Farkas, Elena Huerta-Ramos, Silvia Marcó-García, Matthias Stevens, Tanguy Coenen, Margarita Hospedales, Jesús Berdún, m-Resist group, Eva M Grasa, Francisco Alcalde, Enrico D'amico, Caritat Almazán, István Bitter, Walter Baccinelli, Chiara Bonizzi, María Bugheroni, Xavier Constant, Marisol Escobar, Kata Fazekas, Emmanuel Gimenez, Charlotte Jewel, Teija Juola, Timo Jämsä, Rachelle Kaye, Alejandro Keymer-Gausset, Panagiotis Kokkinakis, Hannu J Koponen, Gregoris Mentzas, Jouko Miettunen, Jani Moilanen, Susana Ochoa, Ilias Papas, Fotis Paraskevopoulos, Elisabeth Reixach, Alexandra Roldán, Elena Rubio-Abadal, Garifalia Sebú, Jussi Seppälä, Valentina Simonetti, Vittorio Tauro, Anna Triantafillou, Judith Usall, David Vermeir, Ilaria De Vita, Anna Alonso-Solís, Katya Rubinstein, Iluminada Corripio, Erika Jaaskelainen, Annika Seppälä, Vincenzo Alberto Vella, Johanna Caro-Mendivelso, Asaf Caspi, Matti Isohanni, Zsolt Unoka, Shenja Van der Graff, Kinga Farkas, Elena Huerta-Ramos, Silvia Marcó-García, Matthias Stevens, Tanguy Coenen, Margarita Hospedales, Jesús Berdún, m-Resist group, Eva M Grasa, Francisco Alcalde, Enrico D'amico, Caritat Almazán, István Bitter, Walter Baccinelli, Chiara Bonizzi, María Bugheroni, Xavier Constant, Marisol Escobar, Kata Fazekas, Emmanuel Gimenez, Charlotte Jewel, Teija Juola, Timo Jämsä, Rachelle Kaye, Alejandro Keymer-Gausset, Panagiotis Kokkinakis, Hannu J Koponen, Gregoris Mentzas, Jouko Miettunen, Jani Moilanen, Susana Ochoa, Ilias Papas, Fotis Paraskevopoulos, Elisabeth Reixach, Alexandra Roldán, Elena Rubio-Abadal, Garifalia Sebú, Jussi Seppälä, Valentina Simonetti, Vittorio Tauro, Anna Triantafillou, Judith Usall, David Vermeir, Ilaria De Vita

Abstract

Introduction: Treatment-resistant schizophrenia (TRS) is a severe form of schizophrenia. In the European Union, approximately 40% of people with schizophrenia have TRS. Factors such as the persistence of positive symptoms or higher risk of comorbidities leave clinicians with a complex scenario when treating these patients. Intervention strategies based on mHealth have demonstrated their ability to support and promote self-management-based strategies. Mobile therapeutic attention for treatment-resistant schizophrenia (m-RESIST), an innovative mHealth solution based on novel technology and offering high modular and flexible functioning, has been developed specifically for patients with TRS and their caregivers. As intervention in TRS is a challenge, it is necessary to perform a feasibility study before the cost-effectiveness testing stage.

Methods and analysis: This manuscript describes the protocol for a prospective multicentre feasibility study in 45 patients with TRS and their caregivers who will be attended in the public health system of three localities: Hospital Santa Creu Sant Pau (Spain), Semmelweis University (Hungary) and Gertner Institute & Sheba Medical Center (Israel). The primary aim is to investigate the feasibility and acceptability of the m-RESIST solution, configured by three mHealth tools: an app, wearable and a web-based platform. The solution collects data about acceptability, usability and satisfaction, together with preliminary data on perceived quality of life, symptoms and economic variables. The secondary aim is to collect preliminary data on perceived quality of life, symptoms and economic variables.

Ethics and dissemination: This study protocol, funded by the Horizon 2020 Programme of the European Union, has the approval of the ethics committees of the participating institutions. Participants will be fully informed of the purpose and procedures of the study, and signed inform consents will be obtained. The results will be published in peer-reviewed journals and presented in scientific conferences to ensure widespread dissemination.

Trial registration number: NCT03064776; Pre-results.

Keywords: feasibility; mhealth; mobile device based intervention; psychosis; treatment-resistant schizophrenia.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
mHealth tools of the m-RESIST solution. m-RESIST, mobile therapeutic attention for treatment-resistant schizophrenia.

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