Schizophreniam-RESISTNCT03064776
Study of m-RESIST, an m-Health Program for Treatment-resistant Schizophrenia
A study testing m-RESIST Patients and m-RESIST Caregivers in people with Schizophrenia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 3 sites in 3 countries.
Trial summary
m-RESIST is an m-health intervention program aimed to develop, test and evaluate a tool to allow patients suffering from treatment-resistant schizophrenia to self-manage their condition. This may facilitate acceptance and involvement of patients with their own treatment, as well as of caregivers. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- m-RESIST Patients and m-RESIST Caregivers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Mar 2017to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Schizophrenia following the diagnostic and statistical manual of mental disorders (DSM-V) criteria.
- Meet criteria for "treatment-resistant schizophrenia", term referred to two different subgroups of patients:
- Patients with schizophrenia who are refractory despite receiving antipsychotic treatment in suitable doses and duration (at least two dopamine D2 receptors antagonist antipsychotics, or on-going treatment with clozapine due to meeting treatment-resistant criteria), and presenting good adherence to treatment (Peuskens, 1999).
- Patients who may be considered pseudo-resistant to the treatment or resistance-like (Elkis \& Meltzer, 2007). In this case, presence of active symptoms may be influenced by psychiatric and medical conditions such as poor insight, negative attitude to medication, social isolation, consumption of toxic substances, presence of nutritional and medical problems, inappropriate health habits, as well as poor alliance and/or environment conditions (low involvement of caregivers in the therapeutic process), which may substantially contribute to poor responses or insufficient effects of medication.
- Duration of disease less than 15 years.
- Used to Information and Communication Technologies (ICT) and having the physical capability to use them (determined using the Technological Readiness Questionnaire).
- Presence of a informal caregiver -family members or significant others- of patients with treatment-resistant schizophrenia.
Who cannot join
- Meet criteria for remission according to the Remission of Schizophrenia Working Group (Andreasen et al., 2005.)
- The presence of delusions mainly related with their therapists or with new technologies.
- Hearing, vision, or motor impairment that makes it impossible to operate a smartphone.
- Presence of a caregiver or Informal carer not used to ICT or physical incapability to use them (determined using the Technological Readiness Questionnaire).
- Presence of intellectual developmental disability.-
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Hungary1 site
3Department of Psychiatry and Psychotherapy, Semmelweis University
Budapest
Israel1 site
The Gertner Institute of Epidemiology and Health Policy Research, Sheba Medical Center
Tel Aviv
Spain1 site
Department of Psychiatry. Hospital Santa Creu i Sant Pau
Barcelona, 08025
About this study
Official title: Pilot Study of m-RESIST, an m-Health Program for Treatment-resistant Schizophrenia: Acceptability, Usability, Satisfaction and Perceived Quality of Life Reported by Patients and Caregivers
m-RESIST is an m-health intervention program aimed to develop, test and evaluate a tool to allow patients suffering from treatment-resistant schizophrenia to self-manage their condition. This may facilitate acceptance and involvement of patients with their own treatment, as well as of caregivers. Moreover this programme could provide a new tool to the psychiatrist, psychologists working together with other health care professionals, to better monitor patients, through a personalised and optimised therapeutic process.
The present document corresponds to the pilot field-trials phase included in a three year European research project, co-funded by the Horizon 2020 Framework Programme of the European Union (grant agreement nº 643552). This document summarises the protocol of the whole therapeutic process, specifying all the procedures included in the program. This protocol will be implemented in three countries: Israel, Hungary and Spain, in order to test acceptability, usability, satisfaction and changes in the quality of life reported by the end-users.
Read the detailed description
The main goal of the present study is to evaluate the acceptability, usability, and satisfaction to m-RESIST solution among the target groups (patients, caregivers, clinicians), and also to evaluate the effect of m-RESIST solution to empowerment and perceived quality of life of the treatment-resistant Schizophrenia patients (TRS). Interventions targeting key problems in TRS (risk behaviours, persistent symptoms of psychosis, poor medication adherence, unhealthy lifestyle habits) will be administered in a clinical setting, with the long-term goal of creating a widely-available system that can be deployed by users as needed, in their own environments.
The study will be conducted in three different regions: Gertner (Israel), Semmelweis (Hungary) and Barcelona (Spain). Consequently, the outcomes obtained in each site and their comparison will allow improving the m-RESIST program in terms of interoperability, integration of components and final implementation of the interactive system in the healthcare pathways.
The participants will be selected from Sheba Medical Center - Psychiatric Division (Tel Aviv), Semmelweis University - Department of Psychiatry and Psychotherapy (Budapest), and the adult psychiatric outpatient service of Hospital de la Santa Creu i Sant Pau (Barcelona).
A total of 45 patients with TRS (15 per centre), with their caregiver, will be included in the trial. All participants will be fully informed about the nature of the study (aims, methodology) and the system tested (data protection, expected risks/benefits, possible adverse events) and they will sign the informed consent for their participation in this study.
- Conditions
- Schizophrenia
- Being tested
- m-RESIST Patients, m-RESIST Caregivers
- Keywords
- telemedicine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
m-RESIST PatientsDevice
A mobile system based on Information and Communications Technology (ICT), which is addressed to empower patients suffering from TRS and to involve their caregivers
m-RESIST CaregiversDevice
A mobile system based on Information and Communications Technology (ICT), which is addressed to empower patients suffering from TRS and to involve their caregivers
| Study group | Role | What they receive |
|---|---|---|
| m-RESIST Patients | Experimental | m-RESIST is a system designed to improve illness self-management and facilitate recovery in individuals with Treatment-resistant schizophrenia (TRS). The system will be used to
1. Continuously capture multidimensional behaviour as it occurs in real-time and in real-world environments, using continuous collection and analysis of sensor data.
2. Detect individual early warning signs, and trigger targeted interventions that may mitigate the severity of worsening or prevent their recurrence altogether, using the clinical decision support system (CDSS) and Recommender operation.
The m-RESIST will deliver both system initiated (i.e. pre-programmed) and patient-initiated (i.e. on-demand) real-time assessments, to the participants and in their own environment. Receives: Device: m-RESIST Patients |
| m-RESIST Caregivers | Experimental | m-RESIST is a system designed to improve illness self-knowledge and facilitate the involvement of caregivers in treatment of individuals with treatment-resistant schizophrenia. Receives: Device: m-RESIST Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Technology Acceptance Model (TAM)
Measured: Changes from baseline scores at 1-month and 3-months scores
Secondary outcomes (7)
Change in User Experience Questionnaire
Measured: Changes from baseline scores at 1-month and 3-months scores
Change in EuroQol-5D Health Questionnaire (EQ-5D)
Measured: Changes from baseline scores at 1-month and 3-months scores
Change in Client Satisfaction Questionnaire (CSQ-8)
Measured: Changes from baseline scores at 1-month and 3-months scores
Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Measured: Changes from baseline scores at 1-month and 3-months scores
Change in Neuropsychological Assessment
Measured: Changes from baseline scores at 1-month and 3-months scores
Change in Clinical Global Impression-Schizophrenia (CGI-SCH)
Measured: Changes from baseline scores at 1-month and 3-months scores
Change in Social Functioning Scale (SFS)
Measured: Changes from baseline scores at 1-month and 3-months scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start1 Mar 2017
- Primary completion1 Jul 2017
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center, Semmelweis University, iMinds, Agència de Qualitat i Avaluació Sanitàries
- Responsible party
- Sponsor
- Investigators
- Corripio Iluminada, MD, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064776
- Sponsor's protocol ID
- IIBSP-RES-2016-51
- Other IDs
- 643552
- Acronym
- m-RESIST
- Status last verified
- Jun 2019
- First submitted
- 17 Oct 2016
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Seppala J, Grasa E, Alonso-Solis A, Roldan-Bejarano A, Haapea M, Isohanni M, Miettunen J, Caro Mendivelso J, Almazan C, Rubinstein K, Caspi A, Unoka Z, Farkas K, Reixach E, Berdun J, Usall J, Ochoa S, Corripio I, Jaaskelainen E; m-Resist Group. Mobile Therapeutic Attention for Treatment-Resistant Schizophrenia (m-RESIST) Solution for Improving Clinical and Functional Outcomes in Treatment-Resistant Schizophrenia: Prospective, Multicenter Efficacy Study. JMIR Hum Factors. 2025 May 15;12:e67659. doi: 10.2196/67659.
PubMed 40372941Grasa E, Seppala J, Alonso-Solis A, Haapea M, Isohanni M, Miettunen J, Caro Mendivelso J, Almazan C, Rubinstein K, Caspi A, Unoka Z, Farkas K, Usall J, Ochoa S, van der Graaf S, Jewell C, Triantafillou A, Stevens M, Reixach E, Berdun J; m-RESIST group; Corripio I. m-RESIST, a Mobile Therapeutic Intervention for Treatment-Resistant Schizophrenia: Feasibility, Acceptability, and Usability Study. JMIR Form Res. 2023 Jun 30;7:e46179. doi: 10.2196/46179.
PubMed 37389933Alonso-Solis A, Rubinstein K, Corripio I, Jaaskelainen E, Seppala A, Vella VA, Caro-Mendivelso J, Caspi A, Isohanni M, Unoka Z, Van der Graff S, Farkas K, Huerta-Ramos E, Marco-Garcia S, Stevens M, Coenen T, Hospedales M, Berdun J; m-Resist group; Grasa EM. 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. doi: 10.1136/bmjopen-2017-021346.
PubMed 30012788
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of m-RESIST, an m-Health Program for Treatment-resistant Schizophrenia: Acceptability, Usability, Satisfaction and Perceived Quality of Life Reported by Patients and Caregivers
- ClinicalTrials.gov ID
- NCT03064776
- Acronym / sponsor ID
- m-RESIST / IIBSP-RES-2016-51
- Conditions
- Schizophrenia
- Keywords
- telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Sheba Medical Center, Semmelweis University, iMinds, Agència de Qualitat i Avaluació Sanitàries
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
m-RESIST is an m-health intervention program aimed to develop, test and evaluate a tool to allow patients suffering from treatment-resistant schizophrenia to self-manage their condition. This may facilitate acceptance and involvement of patients with their own treatment, as well as of caregivers. Moreover this programme could provide a new tool to the psychiatrist, psychologists working together with other health care professionals, to better monitor patients, through a personalised and optimised therapeutic process.
The present document corresponds to the pilot field-trials phase included in a three year European research project, co-funded by the Horizon 2020 Framework Programme of the European Union (grant agreement nº 643552). This document summarises the protocol of the whole therapeutic process, specifying all the procedures included in the program. This protocol will be implemented in three countries: Israel, Hungary and Spain, in order to test acceptability, usability, satisfaction and changes in the quality of life reported by the end-users.
Detailed description
The main goal of the present study is to evaluate the acceptability, usability, and satisfaction to m-RESIST solution among the target groups (patients, caregivers, clinicians), and also to evaluate the effect of m-RESIST solution to empowerment and perceived quality of life of the treatment-resistant Schizophrenia patients (TRS). Interventions targeting key problems in TRS (risk behaviours, persistent symptoms of psychosis, poor medication adherence, unhealthy lifestyle habits) will be administered in a clinical setting, with the long-term goal of creating a widely-available system that can be deployed by users as needed, in their own environments.
The study will be conducted in three different regions: Gertner (Israel), Semmelweis (Hungary) and Barcelona (Spain). Consequently, the outcomes obtained in each site and their comparison will allow improving the m-RESIST program in terms of interoperability, integration of components and final implementation of the interactive system in the healthcare pathways.
The participants will be selected from Sheba Medical Center - Psychiatric Division (Tel Aviv), Semmelweis University - Department of Psychiatry and Psychotherapy (Budapest), and the adult psychiatric outpatient service of Hospital de la Santa Creu i Sant Pau (Barcelona).
A total of 45 patients with TRS (15 per centre), with their caregiver, will be included in the trial. All participants will be fully informed about the nature of the study (aims, methodology) and the system tested (data protection, expected risks/benefits, possible adverse events) and they will sign the informed consent for their participation in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| m-RESIST Patients | Experimental | Device: m-RESIST Patientsm-RESIST is a system designed to improve illness self-management and facilitate recovery in individuals with Treatment-resistant schizophrenia (TRS). The system will be used to 1. Continuously capture multidimensional behaviour as it occurs in real-time and in real-world environments, using continuous collection and analysis of sensor data. 2. Detect individual early warning signs, and trigger targeted interventions that may mitigate the severity of worsening or prevent their recurrence altogether, using the clinical decision support system (CDSS) and Recommender operation. The m-RESIST will deliver both system initiated (i.e. pre-programmed) and patient-initiated (i.e. on-demand) real-time assessments, to the participants and in their own environment. |
| m-RESIST Caregivers | Experimental | Device: m-RESIST Caregiversm-RESIST is a system designed to improve illness self-knowledge and facilitate the involvement of caregivers in treatment of individuals with treatment-resistant schizophrenia. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of Schizophrenia following the diagnostic and statistical manual of mental disorders (DSM-V) criteria.
- Meet criteria for "treatment-resistant schizophrenia", term referred to two different subgroups of patients:
- Duration of disease less than 15 years.
- Used to Information and Communication Technologies (ICT) and having the physical capability to use them (determined using the Technological Readiness Questionnaire).
- Presence of a informal caregiver -family members or significant others- of patients with treatment-resistant schizophrenia.
Key exclusion criteria (5 listed)
- Meet criteria for remission according to the Remission of Schizophrenia Working Group (Andreasen et al., 2005.)
- The presence of delusions mainly related with their therapists or with new technologies.
- Hearing, vision, or motor impairment that makes it impossible to operate a smartphone.
- Presence of a caregiver or Informal carer not used to ICT or physical incapability to use them (determined using the Technological Readiness Questionnaire).
- Presence of intellectual developmental disability.-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| m-RESIST PatientsA mobile system based on Information and Communications Technology (ICT), which is addressed to empower patients suffering from TRS and to involve their caregivers | Device | m-RESIST Patients |
| m-RESIST CaregiversA mobile system based on Information and Communications Technology (ICT), which is addressed to empower patients suffering from TRS and to involve their caregivers | Device | m-RESIST Caregivers |
Primary outcome
Change in Technology Acceptance Model (TAM)
Time frame: Changes from baseline scores at 1-month and 3-months scores
7 secondary outcomes
Change in User Experience Questionnaire
Time frame: Changes from baseline scores at 1-month and 3-months scores
Change in EuroQol-5D Health Questionnaire (EQ-5D)
Time frame: Changes from baseline scores at 1-month and 3-months scores
Change in Client Satisfaction Questionnaire (CSQ-8)
Time frame: Changes from baseline scores at 1-month and 3-months scores
Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time frame: Changes from baseline scores at 1-month and 3-months scores
Change in Neuropsychological Assessment
Time frame: Changes from baseline scores at 1-month and 3-months scores
Change in Clinical Global Impression-Schizophrenia (CGI-SCH)
Time frame: Changes from baseline scores at 1-month and 3-months scores
Change in Social Functioning Scale (SFS)
Time frame: Changes from baseline scores at 1-month and 3-months scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Derived from this study: PubMed 40372941Seppala J, Grasa E, Alonso-Solis A, Roldan-Bejarano A, Haapea M, Isohanni M, Miettunen J, Caro Mendivelso J, Almazan C, Rubinstein K, Caspi A, Unoka Z, Farkas K, Reixach E, Berdun J, Usall J, Ochoa S, Corripio I, Jaaskelainen E; m-Resist Group. Mobile Therapeutic Attention for Treatment-Resistant Schizophrenia (m-RESIST) Solution for Improving Clinical and Functional Outcomes in Treatment-Resistant Schizophrenia: Prospective, Multicenter Efficacy Study. JMIR Hum Factors. 2025 May 15;12:e67659. doi: 10.2196/67659.
- Derived from this study: PubMed 37389933Grasa E, Seppala J, Alonso-Solis A, Haapea M, Isohanni M, Miettunen J, Caro Mendivelso J, Almazan C, Rubinstein K, Caspi A, Unoka Z, Farkas K, Usall J, Ochoa S, van der Graaf S, Jewell C, Triantafillou A, Stevens M, Reixach E, Berdun J; m-RESIST group; Corripio I. m-RESIST, a Mobile Therapeutic Intervention for Treatment-Resistant Schizophrenia: Feasibility, Acceptability, and Usability Study. JMIR Form Res. 2023 Jun 30;7:e46179. doi: 10.2196/46179.
- Derived from this study: PubMed 30012788Alonso-Solis A, Rubinstein K, Corripio I, Jaaskelainen E, Seppala A, Vella VA, Caro-Mendivelso J, Caspi A, Isohanni M, Unoka Z, Van der Graff S, Farkas K, Huerta-Ramos E, Marco-Garcia S, Stevens M, Coenen T, Hospedales M, Berdun J; m-Resist group; Grasa EM. 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. doi: 10.1136/bmjopen-2017-021346.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corripio Iluminada, MD, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing m-RESIST Patients and m-RESIST Caregivers in people with Schizophrenia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary, Israel, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Technology Acceptance Model (TAM) (time frame: Changes from baseline scores at 1-month and 3-months scores). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03064776, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.