Bucci Sandra, Varese Filippo, Quayle Ethel, Cartwright Kim, Machin Matthew, Whelan Pauline, Chitsabesan Prathiba, Richards Cathy, Green Victoria, Norrie John, Schwannauer Matthias
Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science, The University of Manchester, Manchester, United Kingdom.
Greater Manchester Mental Health NHS Foundation Trust, Manchester, United Kingdom.
JMIR Res Protoc. 2023 Mar 21;12:e40539. doi: 10.2196/40539.
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.
背景:对于遭受过技术辅助性虐待(TASA)的年轻人(YP),目前尚无基于证据的支持措施。旨在改善心理化(理解自己和他人心理状态的能力)的干预措施越来越多地被应用于治疗患有各种临床问题的YP。YP中数字技术的使用如今很普遍。针对经历过TASA的YP进行的旨在改善心理化的数字干预,可能会降低再次受害和未来受到伤害的风险,并使YP更具复原力,能够应对TASA经历可能带来的困扰。 目的:在本文中,我们描述了一个方案,用于确定i-Minds试验的可行性以及数字干预(i-Minds应用程序)的可接受性、安全性和可用性,并探索如何最好地将i-Minds纳入现有的常规护理途径。 方法:这是一项混合方法的非随机研究,旨在确定干预措施的可行性、可接受性、安全性和可用性。年龄在12至18岁之间、报告因接触TASA而感到困扰的参与者将从英国的国民健康服务(NHS)信托儿童和青少年心理健康服务机构、性侵犯转介中心以及一家基于网络的电子治疗提供商中招募。所有参与者将使用i-Minds应用程序6周。i-Minds应用程序是与YP和一系列利益相关者共同制作的,重点关注4个主要主题:心理化、TASA及其影响、情绪和心理健康以及创伤。每日提示将鼓励YP使用该应用程序,该应用程序旨在与常规护理并行独立使用。干预结束后,我们将对参与者进行随访,并与利益相关者进行访谈,以探讨应用程序和试验程序的可接受性,并确定改进的领域。基于常态化过程理论,我们将研究与未来将该干预措施纳入现有护理途径(包括传统的基于诊所的NHS和NHS电子治疗提供商)相关的障碍和促进因素。 结果:本研究已获得苏格兰研究伦理委员会的批准。我们预计将从多达60名YP中收集数据。我们预计将对参与者和约20名转介YP参加本研究的医疗保健专业人员进行约20次定性访谈。本研究的结果已提交发表。 结论:本研究将提供关于招募YP参加此类试验的可行性以及i-Minds应用程序的可接受性、安全性和可用性的初步证据,包括如何最好地将其纳入现有常规护理。研究结果将为是否进行有充分效力的疗效试验提供决策依据。 试验注册:国际标准随机对照试验编号注册库(ISRCTN)ISRCTN43130832;https://www.isrctn.com/ISRCTN43130832。 国际注册报告标识符(IRRID):DERR1-10.2196/40539。
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