Pinto Janaina V, Hunt Caroline, O'Toole Brian
Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
Sync Body-Brain Health, Brisbane, Australia.
JMIR Res Protoc. 2022 Jun 15;11(6):e38223. doi: 10.2196/38223.
Decentralized health systems in low- and middle-income countries (LMICs) affected by humanitarian crises lack resources and a qualified workforce to attend to the overwhelming demand for mental health care in emergencies. Innovative approaches that are safe, cost-effective, and scalable are needed to address the burden of traumatic stress caused by emergencies. High mobile phone ownership rates combined with the precision of neural, cognitive, and biometric measures of trauma and their feasible integration with artificial intelligence makes digital app interventions a promising pathway to promote precision diagnosis and high-impact care.
This study aimed to advance methods for the objective diagnosis and treatment of trauma in emergencies across LMICs by examining neural, cognitive, and biometric markers and the efficacy of the eResilience app, a neuroscience-informed mobile health mental health app intervention, via changes in clinical symptomatology, cognitive performance, and brain activity.
Trauma-exposed African refugees residing in Australia were selected for this study. A research software version of the eResilience app with advanced monitoring capabilities was designed for this trial. Participants completed the eResilience app at home during a 7-day period. Clinical, cognitive, and electrophysiological data were collected at baseline, along with posttest measurements to examine biomarkers of trauma and the efficacy of the proposed digital intervention for the treatment of trauma and its potential outcomes, including depression, anxiety, physical symptoms, self-harm, substance misuse, and cognitive impairment. In addition, biofeedback, well-being, and subjective stress data points were collected via the app during the treatment week, followed by clinical interviews at 1, 3, 6, and 12 months after the intervention.
Data collection was conducted between 2018 and 2020. A total of 100 participants exposed to war were screened; 75 (75%) were enrolled and assigned to a trauma-exposed control (38/75, 51%) or posttraumatic stress disorder condition (37/75, 49%); and 70 (70%) completed all baseline, treatment, and posttest assessments. A total of 89% (62/70) of those who completed the intervention opted to enroll in the 3-, 6-, and 12-month follow-ups. Data collection is complete. As of May 2022, the results of all proposed analyses are being prepared for publication. If proven efficacious, this proof-of-concept clinical trial will inform fully powered randomized clinical trials in LMICs to further develop artificial intelligence-powered, app-based diagnostic and prognostic features and determine the app's cross-cultural efficacy for the treatment of trauma in emergency settings.
This protocol provides researchers with a comprehensive background of the study rationale, a detailed guideline for replication studies interested in examining the feasibility and efficacy of the eResilience app across varied demographics, and a robust framework for investigating low-cost objective diagnostic markers in mental health interventions. Methodological limitations and suggestions are also provided.
Australian New Zealand Clinical Trials Registry ACTRN12616001205426; https://tinyurl.com/yckwc4d7.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/38223.
受人道主义危机影响的低收入和中等收入国家（LMICs）的分散式卫生系统缺乏资源和合格的劳动力，难以满足紧急情况下对精神卫生保健的巨大需求。需要采用安全、具有成本效益且可扩展的创新方法来应对紧急情况造成的创伤压力负担。手机拥有率高，再加上创伤的神经、认知和生物特征测量的精确性，以及它们与人工智能的可行整合，使得数字应用程序干预成为促进精准诊断和高影响力护理的一条有前景的途径。
本研究旨在通过检查神经、认知和生物特征标志物以及eResilience应用程序（一款基于神经科学的移动健康心理健康应用程序干预）的疗效，通过临床症状、认知表现和大脑活动的变化，推进LMICs紧急情况下创伤的客观诊断和治疗方法。
本研究选取了居住在澳大利亚的有创伤经历的非洲难民。为该试验设计了具有先进监测功能的eResilience应用程序的研究软件版本。参与者在7天内在家中完成eResilience应用程序。在基线时收集临床、认知和电生理数据，以及测试后测量数据，以检查创伤的生物标志物以及所提议的数字干预措施治疗创伤的疗效及其潜在结果，包括抑郁、焦虑、身体症状、自我伤害、药物滥用和认知障碍。此外，在治疗周期间通过应用程序收集生物反馈、幸福感和主观压力数据点，随后在干预后1、3、6和12个月进行临床访谈。
数据收集于2018年至2020年期间进行。共筛选了100名有战争经历的参与者；75人（75%）被纳入并分配到有创伤经历的对照组（38/75，51%）或创伤后应激障碍组（37/75，49%）；70人（70%）完成了所有基线、治疗和测试后评估。完成干预的参与者中共有89%（62/70）选择参加3个月、6个月和12个月的随访。数据收集已完成。截至2022年5月，所有提议分析的结果正在准备发表。如果被证明有效，这项概念验证临床试验将为LMICs中充分有力的随机临床试验提供信息，以进一步开发基于人工智能的、基于应用程序的诊断和预后特征，并确定该应用程序在紧急情况下治疗创伤的跨文化疗效。
本方案为研究人员提供了研究原理的全面背景、对有兴趣研究eResilience应用程序在不同人群中的可行性和疗效的复制研究的详细指南，以及用于调查心理健康干预中低成本客观诊断标志物的强大框架。还提供了方法学上的局限性和建议。
澳大利亚新西兰临床试验注册中心ACTRN12616001205426；https://tinyurl.com/yckwc4d7。
国际注册报告识别码（IRRID）：RR1-10.2196/38223。
