acceptability; adherence; digital intervention; digital mental health; feasibility; mHealth; mental disorder; mental health; mental illness; mobile health; mobile intervention; mobile phone; psychosis; schizophrenia; symptom management; treatment-resistant; usability; Medicine (miscellaneous); Health Informatics
Abstract :
BACKGROUND: In the European Union, around 5 million people are affected by psychotic disorders, and approximately 30%-50% of people with schizophrenia have treatment-resistant schizophrenia (TRS). Mobile health (mHealth) interventions may be effective in preventing relapses, increasing treatment adherence, and managing some of the symptoms of schizophrenia. People with schizophrenia seem willing and able to use smartphones to monitor their symptoms and engage in therapeutic interventions. mHealth studies have been performed with other clinical populations but not in populations with TRS.
OBJECTIVE: The purpose of this study was to present the 3-month prospective results of the m-RESIST intervention. This study aims to assess the feasibility, acceptability, and usability of the m-RESIST intervention and the satisfaction among patients with TRS after using this intervention.
METHODS: A prospective multicenter feasibility study without a control group was undertaken with patients with TRS. This study was performed at 3 sites: Sant Pau Hospital (Barcelona, Spain), Semmelweis University (Budapest, Hungary), and Sheba Medical Center and Gertner Institute of Epidemiology and Health Policy Research (Ramat-Gan, Israel). The m-RESIST intervention consisted of a smartwatch, a mobile app, a web-based platform, and a tailored therapeutic program. The m-RESIST intervention was delivered to patients with TRS and assisted by mental health care providers (psychiatrists and psychologists). Feasibility, usability, acceptability, and user satisfaction were measured.
RESULTS: This study was performed with 39 patients with TRS. The dropout rate was 18% (7/39), the main reasons being as follows: loss to follow-up, clinical worsening, physical discomfort of the smartwatch, and social stigma. Patients' acceptance of m-RESIST ranged from moderate to high. The m-RESIST intervention could provide better control of the illness and appropriate care, together with offering user-friendly and easy-to-use technology. In terms of user experience, patients indicated that m-RESIST enabled easier and quicker communication with clinicians and made them feel more protected and safer. Patients' satisfaction was generally good: 78% (25/32) considered the quality of service as good or excellent, 84% (27/32) reported that they would use it again, and 94% (30/32) reported that they were mostly satisfied.
CONCLUSIONS: The m-RESIST project has provided the basis for a new modular program based on novel technology: the m-RESIST intervention. This program was well-accepted by patients in terms of acceptability, usability, and satisfaction. Our results offer an encouraging starting point regarding mHealth technologies for patients with TRS.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03064776; https://clinicaltrials.gov/ct2/show/record/NCT03064776.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2017-021346.
Disciplines :
Treatment & clinical psychology
Author, co-author :
Grasa, Eva ; Mental Health, Institut d'Investigació Biomèdica Sant Pau (IIB SANT PAU), Barcelona, Spain ; Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Salud Carlos III, Madrid, Spain
Seppälä, Jussi ; Social Insurance Institution of Finland, Kuopio, Finland ; Research Unit of Population Health, University of Oulu, Oulu, Finland
Alonso-Solis, Anna ; Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Salud Carlos III, Madrid, Spain ; Mental Health Division, Fundació Althaia, Xarxa Assistencial Universitaria de Manresa, Manresa, Spain
Haapea, Marianne ; Research Unit of Population Health, University of Oulu, Oulu, Finland ; Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland ; Department of Psychiatry, Oulu University Hospital, Oulu, Finland
Isohanni, Matti ; Research Unit of Population Health, University of Oulu, Oulu, Finland
Miettunen, Jouko ; Research Unit of Population Health, University of Oulu, Oulu, Finland ; Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland
Caro Mendivelso, Johanna ; Agency for Health Quality and Assessment of Catalonia (AQuAS), Barcelona, Spain
Almazan, Cari ; Agency for Health Quality and Assessment of Catalonia (AQuAS), Barcelona, Spain
Rubinstein, Katya ; The Gertner Institute of Epidemiology and Health Policy Research, Sheba Medical Center, Tel-Aviv University, Tel-Aviv, Israel
Caspi, Asaf ; The Gertner Institute of Epidemiology and Health Policy Research, Sheba Medical Center, Tel-Aviv University, Tel-Aviv, Israel
Unoka, Zsolt ; Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary
Farkas, Kinga ; Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary
Usall, Judith ; Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Salud Carlos III, Madrid, Spain ; Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain ; Etiopatogènia i tractament dels trastorns mentals greus (MERITT), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain
Ochoa, Susana ; Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Salud Carlos III, Madrid, Spain ; Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain ; Etiopatogènia i tractament dels trastorns mentals greus (MERITT), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain
van der Graaf, Shenja ; Department of Communication Science, University of Twente, Twente, Netherlands
Jewell, Charlotte ; Université de Liège - ULiège > Institut de recherche en Sciences Sociales (IRSS)
Triantafillou, Anna ; Athens Technology Center, Athens, Greece
Reixach, Elisenda ; TicSalut Health Department, Generalitat de Catalunya, Barcelona, Spain
Berdun, Jesus ; Digital Health Unit, Hospital de la Santa Creu i Sant Pau, Institut d'Investigació Biomèdica Sant Pau (IIB SANT PAU), Barcelona, Spain
m-RESIST group
Corripio, Iluminada ; Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Salud Carlos III, Madrid, Spain ; Mental Health and Psychiatry Department, Vic Hospital Consortium, Vic, Spain
m-RESIST, a Mobile Therapeutic Intervention for Treatment-Resistant Schizophrenia: Feasibility, Acceptability, and Usability Study.
Publication date :
2023
Journal title :
JMIR Formative Research
eISSN :
2561-326X
Publisher :
JMIR Publications Inc., Canada
Volume :
7
Pages :
e46179
Peer reviewed :
Peer Reviewed verified by ORBi
European Projects :
H2020 - 643552 - m-RESIST - Mobile Therapeutic Attention for Patients with Treatment Resistant Schizophrenia
Funders :
EU - European Union Generalitat de Catalunya
Funding text :
This work has been supported by the Horizon 2020 Framework Programme of the European Union (grant 643552) and partly funded by CERCA (Centres de Recerca de Catalunya) Programme/Generalitat de Catalunya. We thank all the patients who participated in this study for their essential contribution to our field of research. We are also thankful to Ona Corporation (IIBSP-AMA2016-99).
Leucht S, Busch R, Kissling W, Kane JM. Early prediction of antipsychotic nonresponse among patients with schizophrenia. J Clin Psychiatry 2007 Mar;68(3):352-360 [doi: 10.4088/jcp.v68n0301] [Medline: 17388703]
Jääskeläinen E, Juola P, Hirvonen N, McGrath JJ, Saha S, Isohanni M, et al. A systematic review and meta-analysis of recovery in schizophrenia. Schizophr Bull 2013 Nov;39(6):1296-1306 [FREE Full _text] [doi: 10.1093/schbul/sbs130] [Medline: 23172003]
Kennedy JL, Altar CA, Taylor DL, Degtiar I, Hornberger JC. The social and economic burden of treatment-resistant schizophrenia: a systematic literature review. Int Clin Psychopharmacol 2014 Mar;29(2):63-76 [doi: 10.1097/YIC.0b013e32836508e6] [Medline: 23995856]
Mortimer AM, Singh P, Shepherd CJ, Puthiryackal J. Clozapine for treatment-resistant schizophrenia: National Institute of Clinical Excellence (NICE) guidance in the real world. Clin Schizophr Relat Psychoses 2010 Apr;4(1):49-55 [Medline: 20643629]
Millier A, Schmidt U, Angermeyer MC, Chauhan D, Murthy V, Toumi M, et al. Humanistic burden in schizophrenia: a literature review. J Psychiatr Res 2014 Jul;54:85-93 [FREE Full _text] [doi: 10.1016/j.jpsychires.2014.03.021] [Medline: 24795289]
Ben-Zeev D, Brenner CJ, Begale M, Duffecy J, Mohr DC, Mueser KT. Feasibility, acceptability, and preliminary efficacy of a smartphone intervention for schizophrenia. Schizophr Bull 2014 Nov;40(6):1244-1253 [FREE Full _text] [doi: 10.1093/schbul/sbu033] [Medline: 24609454]
Granholm E, Ben-Zeev D, Link PC, Bradshaw KR, Holden JL. Mobile Assessment and Treatment for Schizophrenia (MATS): a pilot trial of an interactive text-messaging intervention for medication adherence, socialization, and auditory hallucinations. Schizophr Bull 2012 May;38(3):414-425 [FREE Full _text] [doi: 10.1093/schbul/sbr155] [Medline: 22080492]
Palmier-Claus JE, Ainsworth J, Machin M, Barrowclough C, Dunn G, Barkus E, et al. The feasibility and validity of ambulatory self-report of psychotic symptoms using a smartphone software application. BMC Psychiatry 2012 Oct 17;12:172 [FREE Full _text] [doi: 10.1186/1471-244X-12-172] [Medline: 23075387]
Firth J, Cotter J, Torous J, Bucci S, Firth JA, Yung AR. Mobile Phone Ownership and Endorsement of "mHealth" Among People With Psychosis: A Meta-analysis of Cross-sectional Studies. Schizophr Bull 2016 Mar;42(2):448-455 [FREE Full text] [doi: 10.1093/schbul/sbv132] [Medline: 26400871]
Brunette MF, Achtyes E, Pratt S, Stilwell K, Opperman M, Guarino S, et al. Use of Smartphones, Computers and Social Media Among People with SMI: Opportunity for Intervention. Community Ment Health J 2019 Aug;55(6):973-978 [FREE Full _text] [doi: 10.1007/s10597-019-00431-7] [Medline: 31175518]
Young AS, Cohen AN, Niv N, Nowlin-Finch N, Oberman RS, Olmos-Ochoa TT, et al. Mobile Phone and Smartphone Use by People With Serious Mental Illness. Psychiatr Serv 2020 Mar 01;71(3):280-283 [FREE Full _text] [doi: 10.1176/appi.ps.201900203] [Medline: 31744429]
Firth J, Torous J. Smartphone Apps for Schizophrenia: A Systematic Review. JMIR Mhealth Uhealth 2015 Nov 06;3(4):e102 [FREE Full _text] [doi: 10.2196/mhealth.4930] [Medline: 26546039]
Bonet L, Izquierdo C, Escartí MJ, Sancho JV, Arce D, Blanquer I, et al. Use of mobile technologies in patients with psychosis: A systematic review. Revista de Psiquiatría y Salud Mental (English Edition) 2017 Jul;10(3):168-178 [doi: 10.1016/j.rpsmen.2017.05.010]
Buck B, Scherer E, Brian R, Wang R, Wang W, Campbell A, et al. Relationships between smartphone social behavior and relapse in schizophrenia: A preliminary report. Schizophr Res 2019 Jun;208:167-172 [FREE Full _text] [doi: 10.1016/j.schres.2019.03.014] [Medline: 30940400]
Kidd SA, Feldcamp L, Adler A, Kaleis L, Wang W, Vichnevetski K, et al. Feasibility and outcomes of a multi-function mobile health approach for the schizophrenia spectrum: App4Independence (A4i). PLoS One 2019;14(7):e0219491 [FREE Full _text] [doi: 10.1371/journal.pone.0219491] [Medline: 31306439]
Seppälä J, De Vita I, Jämsä T, Miettunen J, Isohanni M, Rubinstein K, M-RESIST Group, et al. Mobile Phone and Wearable Sensor-Based mHealth Approaches for Psychiatric Disorders and Symptoms: Systematic Review. JMIR Ment Health 2019 Feb 20;6(2):e9819 [FREE Full _text] [doi: 10.2196/mental.9819] [Medline: 30785404]
Alonso-Solís A, Rubinstein K, Corripio I, Jaaskelainen E, Seppälä A, Vella VA, m-Resist group, et al. Mobile therapeutic attention for treatment-resistant schizophrenia (m-RESIST): a prospective multicentre feasibility study protocol in patients and their caregivers. BMJ Open 2018 Jul 16;8(7):e021346 [FREE Full _text] [doi: 10.1136/bmjopen-2017-021346] [Medline: 30012788]
Peuskens J. The evolving definition of treatment resistance. J Clin Psychiatry 1999;60 Suppl 12:4-8 [Medline: 10372602]
Andreasen NC, Carpenter WT, Kane JM, Lasser RA, Marder SR, Weinberger DR. Remission in schizophrenia: proposed criteria and rationale for consensus. Am J Psychiatry 2005 Mar;162(3):441-449 [doi: 10.1176/appi.ajp.162.3.441] [Medline: 15741458]
Davis FD. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly 1989 Sep;13(3):319 [doi: 10.2307/249008]
Eriksson M, Niitamo V, Kulkki S. State-of-the-art in utilizing Living Labs approach to user-centric ICT innovation - a European approach. Living Labs. 2005. URL: https://www.semanticscholar.org/paper/State-ofthe-art-in-utilizing-LivingLabs-approach-Eriksson/2edd5e0fef9f7f9fd0262dea937cb997b3ab8d5f [accessed 2023-05-31]
Chau PY, Hu PJ. Examining a Model of Information Technology Acceptance by Individual Professionals: An Exploratory Study. Journal of Management Information Systems 2014 Dec 23;18(4):191-229 [doi: 10.1080/07421222.2002.11045699]
Gagnon MP, Orruño E, Asua J, Abdeljelil AB, Emparanza J. Using a modified technology acceptance model to evaluate healthcare professionals' adoption of a new telemonitoring system. Telemed J E Health 2012;18(1):54-59 [FREE Full _text] [doi: 10.1089/tmj.2011.0066] [Medline: 22082108]
Roberts RE, Attkisson C. Assessing client satisfaction among Hispanics. Eval Program Plann 1983;6(3-4):401-413 [doi: 10.1016/0149-7189(83)90019-8] [Medline: 10267267]
Mayring P. Qualitative Content Analysis: Theoretical Foundation, Basic Procedures and Software Solution. Austria: Klagenfurt; 2014.
Thabane L, Hopewell S, Lancaster GA, Bond CM, Coleman CL, Campbell MJ, et al. Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud 2016;2:25 [FREE Full text] [doi: 10.1186/s40814-016-0065-z] [Medline: 27965844]
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016 Oct 24;355:i5239 [FREE Full _text] [doi: 10.1136/bmj.i5239] [Medline: 27777223]
Aschbrenner KA, Naslund JA, Barre LK, Mueser KT, Kinney A, Bartels SJ. Peer health coaching for overweight and obese individuals with serious mental illness: intervention development and initial feasibility study. Transl Behav Med 2015 Sep;5(3):277-284 [FREE Full _text] [doi: 10.1007/s13142-015-0313-4] [Medline: 26327933]
Buck B, Hallgren KA, Scherer E, Brian R, Wang R, Wang W, et al. Capturing behavioral indicators of persecutory ideation using mobile technology. J Psychiatr Res 2019 Sep;116:112-117 [FREE Full _text] [doi: 10.1016/j.jpsychires.2019.06.002] [Medline: 31226579]
Kerz M, Folarin A, Meyer N, Begale M, Maccabe J, Dobson R. SleepSight: A wearables-based relapse prevention system for schizophrenia. 2016 Presented at: UbiComp '16: Proceedings of the 2016 ACM International Joint Conference on Pervasive and Ubiquitous Computing: Adjunct; September 12-16; New York, USA URL: https://discovery.ucl.ac.uk/id/ eprint/1528435/ [doi: 10.1145/2968219.2971419]
Alvarez-Jimenez M, Alcazar-Corcoles MA, González-Blanch C, Bendall S, McGorry PD, Gleeson JF. Online, social media and mobile technologies for psychosis treatment: a systematic review on novel user-led interventions. Schizophr Res 2014 Jun;156(1):96-106 [doi: 10.1016/j.schres.2014.03.021] [Medline: 24746468]
Ainsworth J, Palmier-Claus JE, Machin M, Barrowclough C, Dunn G, Rogers A, et al. A comparison of two delivery modalities of a mobile phone-based assessment for serious mental illness: native smartphone application vs text-messaging only implementations. J Med Internet Res 2013 Apr 05;15(4):e60 [FREE Full _text] [doi: 10.2196/jmir.2328] [Medline: 23563184]
Laine A, Välimäki M, Pekurinen V, Löyttyniemi E, Marttunen M, Anttila M. Feasibility, Acceptability, and Preliminary Impacts of Web-Based Patient Education on Patients With Schizophrenia Spectrum Disorder: Quasi-Experimental Cluster Study. J Med Internet Res 2019 Oct 17;21(10):e13073 [FREE Full _text] [doi: 10.2196/13073] [Medline: 31625952]
Eisner E, Bucci S, Berry N, Emsley R, Barrowclough C, Drake RJ. Feasibility of using a smartphone app to assess early signs, basic symptoms and psychotic symptoms over six months: A preliminary report. Schizophr Res 2019 Jun;208:105-113 [FREE Full _text] [doi: 10.1016/j.schres.2019.04.003] [Medline: 30979665]
Kreyenbuhl J, Record EJ, Himelhoch S, Charlotte M, Palmer-Bacon J, Dixon LB, et al. Development and Feasibility Testing of a Smartphone Intervention to Improve Adherence to Antipsychotic Medications. Clin Schizophr Relat Psychoses 2019;12(4):152-167 [FREE Full _text] [Medline: 27454213]
Ben-Zeev D, Kaiser SM, Krzos I. Remote "hovering" with individuals with psychotic disorders and substance use: feasibility, engagement, and therapeutic alliance with a text-messaging mobile interventionist. J Dual Diagn 2014;10(4):197-203 [FREE Full _text] [doi: 10.1080/15504263.2014.962336] [Medline: 25391277]
de Almeida RS, Couto A, Marques A, Queirós C, Martins C. Mobile Application for Self-Management in Schizophrenia: A Pilot Study. Journal of Technology in Human Services 2018 Jul 31;36(4):179-190 [doi: 10.1080/15228835.2018.1483859]
Baumel A, Correll CU, Hauser M, Brunette M, Rotondi A, Ben-Zeev D, et al. Health Technology Intervention After Hospitalization for Schizophrenia: Service Utilization and User Satisfaction. Psychiatr Serv 2016 Sep 01;67(9):1035-1038 [doi: 10.1176/appi.ps.201500317] [Medline: 27247171]
Berry N, Lobban F, Emsley R, Bucci S. Acceptability of Interventions Delivered Online and Through Mobile Phones for People Who Experience Severe Mental Health Problems: A Systematic Review. J Med Internet Res 2016 May 31;18(5):e121 [FREE Full _text] [doi: 10.2196/jmir.5250] [Medline: 27245693]
Chivilgina O, Wangmo T, Elger BS, Heinrich T, Jotterand F. mHealth for schizophrenia spectrum disorders management: A systematic review. Int J Soc Psychiatry 2020 Nov;66(7):642-665 [doi: 10.1177/0020764020933287] [Medline: 32571123]
Ben-Zeev D, Brian RM, Jonathan G, Razzano L, Pashka N, Carpenter-Song E, et al. Mobile Health (mHealth) Versus Clinic-Based Group Intervention for People With Serious Mental Illness: A Randomized Controlled Trial. Psychiatr Serv 2018 Sep 01;69(9):978-985 [doi: 10.1176/appi.ps.201800063] [Medline: 29793397]
Ghaemi SN, Sverdlov O, van Dam J, Campellone T, Gerwien R. A Smartphone-Based Intervention as an Adjunct to Standard-of-Care Treatment for Schizophrenia: Randomized Controlled Trial. JMIR Form Res 2022 Mar 28;6(3):e29154 [FREE Full _text] [doi: 10.2196/29154] [Medline: 35343910]
Naslund JA, Aschbrenner KA, Barre LK, Bartels SJ. Feasibility of popular m-health technologies for activity tracking among individuals with serious mental illness. Telemed J E Health 2015 Mar;21(3):213-216 [FREE Full _text] [doi: 10.1089/tmj.2014.0105] [Medline: 25536190]
Macias C, Panch T, Hicks YM, Scolnick JS, Weene DL, Öngür D, et al. Using Smartphone Apps to Promote Psychiatric and Physical Well-Being. Psychiatr Q 2015 Dec;86(4):505-519 [doi: 10.1007/s11126-015-9337-7] [Medline: 25636496]
Rotondi AJ, Eack SM, Hanusa BH, Spring MB, Haas GL. Critical design elements of e-health applications for users with severe mental illness: singular focus, simple architecture, prominent contents, explicit navigation, and inclusive hyperlinks. Schizophr Bull 2015 Mar;41(2):440-448 [FREE Full _text] [doi: 10.1093/schbul/sbt194] [Medline: 24375458]
Huerta-Ramos E, Escobar-Villegas MS, Rubinstein K, Unoka ZS, Grasa E, Hospedales M, M-RESIST Group, et al. Measuring Users' Receptivity Toward an Integral Intervention Model Based on mHealth Solutions for Patients With Treatment-Resistant Schizophrenia (m-RESIST): A Qualitative Study. JMIR Mhealth Uhealth 2016 Sep 28;4(3):e112 [FREE Full _text] [doi: 10.2196/mhealth.5716] [Medline: 27682896]
Isohanni M, Miettunen J, Penttilä M. Life span development of schizophrenia: symptoms, clinical course, and outcomes. In: Psychotic Disorders: Comprehensive Conceptualization and Treatments. New York: Oxford University Press; 2020.
