TY - JOUR
T1 - A Digital Intervention to Improve Mental Health and Interpersonal Resilience in Young People Who Have Experienced Technology-Assisted Sexual Abuse
T2 - Protocol for a Nonrandomized Feasibility Clinical Trial and Nested Qualitative Study
AU - Bucci, Sandra
AU - Varese, Filippo
AU - Quayle, Ethel
AU - Cartwright, Kim
AU - Machin, Matthew
AU - Whelan, Pauline
AU - Chitsabesan, Prathiba
AU - Richards, Cathy
AU - Green, Victoria
AU - Norrie, John
AU - Schwannauer, Matthias
N1 - Funding Information:
Unrelated to this project, SB and PW are directors and shareholders of CareLoop Health Ltd, which develops and markets digital therapeutics for schizophrenia and a digital screening app for postnatal depression. SB also reports research funding from the National Institute for Health and Care Research and Wellcome Trust. PW is also a Director of Prism Life Ltd, a small research and consultancy company, unrelated to this project.
Funding Information:
The trial is funded by the NIHR Health and Social Care Delivery Research program. The study took place across the CAMHS and sexual assault referral centers in Greater Manchester (England) and Edinburgh (Scotland). We also aimed to recruit participants from an NHS-commissioned national (England) e-therapy provider (Kooth).
Funding Information:
This study was funded by the National Institute for Health and Care Research (NIHR) and Health Services and Delivery Research Program (NIHR 131848). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. This study was supported by the National Institute of Health Clinical Research Network. The authors would like to thank lived experience and professionals’ advisory groups in developing the trial procedures, as well as the members of our project steering committee and Data Monitoring and Ethics Committee for their independent monitoring and advice.
Publisher Copyright:
© Sandra Bucci, Filippo Varese, Ethel Quayle, Kim Cartwright, Matthew Machin, Pauline Whelan, Prathiba Chitsabesan, Cathy Richards, Victoria Green, John Norrie, Matthias Schwannauer.
PY - 2023/3/21
Y1 - 2023/3/21
N2 - BACKGROUND: 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.OBJECTIVE: 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.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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.TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number Registry (ISRCTN) ISRCTN43130832; https://www.isrctn.com/ISRCTN43130832.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40539.
AB - BACKGROUND: 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.OBJECTIVE: 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.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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.TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number Registry (ISRCTN) ISRCTN43130832; https://www.isrctn.com/ISRCTN43130832.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40539.
KW - abuse
KW - digital
KW - eHealth
KW - mHealth
KW - mobile health
KW - mobile phone
KW - technology-assisted sexual abuse
KW - young people
U2 - 10.2196/40539
DO - 10.2196/40539
M3 - Article
C2 - 36943343
SN - 1929-0748
VL - 12
SP - e40539
JO - JMIR Research Protocols
JF - JMIR Research Protocols
M1 - e40539
ER -