ORCID Profile
0000-0002-4683-2596
Current Organisations
The University of Edinburgh
,
Philipps-Universitat Marburg
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Publisher: JMIR Publications Inc.
Date: 25-06-2022
Abstract: o evidence-based support has been offered to young people (YP) who have experienced technology-assisted sexual abuse (TASA). Interventions aimed at improving mentalization (the ability to understand the mental states of oneself and others) are increasingly being applied to treat YP with various clinical issues. Digital technology use among YP is now common. A digital intervention aimed at improving mentalization in YP who have experienced TASA may reduce the risk of revictimization and future harm and make YP more resilient and able to manage distress that might result from TASA experiences. n this paper, we describe a protocol for determining the feasibility of the i-Minds trial and the acceptability, safety, and usability of the digital intervention (the i i-Minds /i app) and explore how to best integrate i-Minds into existing routine care pathways. his is a mixed methods nonrandomized study aimed to determine the feasibility, acceptability, safety, and usability of the intervention. Participants aged between 12 and 18 years who report distress associated with TASA exposure will be recruited from the United Kingdom from the National Health Service (NHS) Trust Child and Adolescent Mental Health Services, sexual assault referral centers, and a web-based e-therapy provider. All participants will receive the i-Minds app for 6 weeks. Coproduced with YP and a range of stakeholders, the i-Minds app focuses on 4 main topics: mentalization, TASA and its impact, emotional and mental health, and trauma. A daily prompt will encourage YP to use the app, which is designed to be used in a stand-alone manner alongside routine care. We will follow participants up after the intervention and conduct interviews with stakeholders to explore the acceptability of the app and trial procedures and identify areas for improvement. Informed by the normalization process theory, we will examine barriers and enablers relevant to the future integration of the intervention into existing care pathways, including traditional clinic-based NHS and NHS e-therapy providers. his study was approved by the Research Ethics Board of Scotland. We expect data to be collected from up to 60 YP. We expect to conduct approximately 20 qualitative interviews with participants and 20 health care professionals who referred YP to the study. The results of this study have been submitted for publication. his study will provide preliminary evidence on the feasibility of recruiting YP to a trial of this nature and on the acceptability, safety, and usability of the i-Minds app, including how to best integrate it into existing routine care. The findings will inform the decision to proceed with a powered efficacy trial. nternational Standard Randomised Controlled Trial Number Registry (ISRCTN) ISRCTN43130832 www.isrctn.com/ISRCTN43130832 ERR1-10.2196/40539
Publisher: JMIR Publications Inc.
Date: 09-01-2020
DOI: 10.2196/15058
Abstract: Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, s le size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. International Standard Randomized Controlled Trial Number (ISRCTN): 99559262 isrctn.com/ISRCTN99559262 DERR1-10.2196/15058
Publisher: JMIR Publications Inc.
Date: 17-06-2019
Abstract: elapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. his study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. e will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. ecruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. he knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, s le size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. nternational Standard Randomized Controlled Trial Number (ISRCTN): 99559262 isrctn.com/ISRCTN99559262
Publisher: JMIR Publications Inc.
Date: 21-03-2023
DOI: 10.2196/40539
Abstract: No evidence-based support has been offered to young people (YP) who have experienced technology-assisted sexual abuse (TASA). Interventions aimed at improving mentalization (the ability to understand the mental states of oneself and others) are increasingly being applied to treat YP with various clinical issues. Digital technology use among YP is now common. A digital intervention aimed at improving mentalization in YP who have experienced TASA may reduce the risk of revictimization and future harm and make YP more resilient and able to manage distress that might result from TASA experiences. In this paper, we describe a protocol for determining the feasibility of the i-Minds trial and the acceptability, safety, and usability of the digital intervention (the i-Minds app) and explore how to best integrate i-Minds into existing routine care pathways. This is a mixed methods nonrandomized study aimed to determine the feasibility, acceptability, safety, and usability of the intervention. Participants aged between 12 and 18 years who report distress associated with TASA exposure will be recruited from the United Kingdom from the National Health Service (NHS) Trust Child and Adolescent Mental Health Services, sexual assault referral centers, and a web-based e-therapy provider. All participants will receive the i-Minds app for 6 weeks. Coproduced with YP and a range of stakeholders, the i-Minds app focuses on 4 main topics: mentalization, TASA and its impact, emotional and mental health, and trauma. A daily prompt will encourage YP to use the app, which is designed to be used in a stand-alone manner alongside routine care. We will follow participants up after the intervention and conduct interviews with stakeholders to explore the acceptability of the app and trial procedures and identify areas for improvement. Informed by the normalization process theory, we will examine barriers and enablers relevant to the future integration of the intervention into existing care pathways, including traditional clinic-based NHS and NHS e-therapy providers. This study was approved by the Research Ethics Board of Scotland. We expect data to be collected from up to 60 YP. We expect to conduct approximately 20 qualitative interviews with participants and 20 health care professionals who referred YP to the study. The results of this study have been submitted for publication. This study will provide preliminary evidence on the feasibility of recruiting YP to a trial of this nature and on the acceptability, safety, and usability of the i-Minds app, including how to best integrate it into existing routine care. The findings will inform the decision to proceed with a powered efficacy trial. International Standard Randomised Controlled Trial Number Registry (ISRCTN) ISRCTN43130832 www.isrctn.com/ISRCTN43130832 DERR1-10.2196/40539
Publisher: National Institute for Health and Care Research
Date: 05-2022
DOI: 10.3310/HLZE0479
Abstract: Relapse is a major determinant of outcome for people with a diagnosis of schizophrenia. Early warning signs frequently precede relapse. A recent Cochrane Review found low-quality evidence to suggest a positive effect of early warning signs interventions on hospitalisation and relapse. How feasible is a study to investigate the clinical effectiveness and cost-effectiveness of a digital intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? A multicentre, two-arm, parallel-group cluster randomised controlled trial involving eight community mental health services, with 12-month follow-up. Glasgow, UK, and Melbourne, Australia. Service users were aged 16 years and had a schizophrenia spectrum disorder with evidence of a relapse within the previous 2 years. Carers were eligible for inclusion if they were nominated by an eligible service user. The Early signs Monitoring to Prevent relapse in psychosis and prOmote Wellbeing, Engagement, and Recovery (EMPOWER) intervention was designed to enable participants to monitor changes in their well-being daily using a mobile phone, blended with peer support. Clinical triage of changes in well-being that were suggestive of early signs of relapse was enabled through an algorithm that triggered a check-in prompt that informed a relapse prevention pathway, if warranted. The main outcomes were feasibility of the trial and feasibility, acceptability and usability of the intervention, as well as safety and performance. Candidate co-primary outcomes were relapse and fear of relapse. We recruited 86 service users, of whom 73 were randomised (42 to EMPOWER and 31 to treatment as usual). Primary outcome data were collected for 84% of participants at 12 months. Feasibility data for people using the smartphone application (app) suggested that the app was easy to use and had a positive impact on motivations and intentions in relation to mental health. Actual app usage was high, with 91% of users who completed the baseline period meeting our a priori criterion of acceptable engagement ( 33%). The median time to discontinuation of 33% app usage was 32 weeks (95% confidence interval 14 weeks to ∞). There were 8 out of 33 (24%) relapses in the EMPOWER arm and 13 out of 28 (46%) in the treatment-as-usual arm. Fewer participants in the EMPOWER arm had a relapse (relative risk 0.50, 95% confidence interval 0.26 to 0.98), and time to first relapse (hazard ratio 0.32, 95% confidence interval 0.14 to 0.74) was longer in the EMPOWER arm than in the treatment-as-usual group. At 12 months, EMPOWER participants were less fearful of having a relapse than those in the treatment-as-usual arm (mean difference –4.29, 95% confidence interval –7.29 to –1.28). EMPOWER was more costly and more effective, resulting in an incremental cost-effectiveness ratio of £3041. This incremental cost-effectiveness ratio would be considered cost-effective when using the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. This was a feasibility study and the outcomes detected cannot be taken as evidence of efficacy or effectiveness. A trial of digital technology to monitor early warning signs that blended with peer support and clinical triage to detect and prevent relapse is feasible. A main trial with a s le size of 500 (assuming 90% power and 20% dropout) would detect a clinically meaningful reduction in relapse (relative risk 0.7) and improvement in other variables (effect sizes 0.3–0.4). This trial is registered as ISRCTN99559262. This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 26, No. 27. See the NIHR Journals Library website for further project information. Funding in Australia was provided by the National Health and Medical Research Council (APP1095879).
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Matthias Schwannauer.