JMIR Publications

ABSTRACT

Background:

Decentralised health systems in Low and Middle-Income Countries (LMICs) impacted 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 brought by emergencies. High mobile phone ownership rates combined with the precision of neural, cognitive, and biometric measures of trauma and its feasible integration with Artificial Intelligence (AI) makes digital application (app) interventions a promising pathway to promote precision diagnosis and high-impact care.

Objective:

The aims of this study are to advance methods for the objective diagnosis and treatment of trauma in emergencies across LMICs by examining (i) neural, cognitive, and biometric markers and (ii) 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.

Methods:

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 the trial. Participants completed the eResilience App at home during a seven-day period. Clinical, cognitive, and electrophysiological data were collected during baseline and post-test 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, wellbeing, 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 post-intervention.

Results:

Data collection was conducted between 2018 and 2020. A total n=100 participants exposed to war were screened, n= 75 were enrolled and assigned to a trauma-exposed control (n=38) or Posttraumatic Stress Disorder (PTSD) condition (n=37), and n= 70 completed all baseline, treatment, and post-test assessments. A total n=62 of the n=70 who completed the intervention opted to enrol in the 3, 6 and 12-month follow-ups. Data collection is complete, and results are being prepared for publication. If proven efficacious, this proof-of-concept clinical trial will inform fully powered randomised clinical trials in LMICs to further develop AI-powered, app-based diagnostic and prognostic features, and determine the app’s cross-cultural efficacy for the treatment of trauma in emergency settings.

Conclusions:

This protocol provides researchers with a comprehensive background of the study rationale, a detailed guideline for replication studies interested in examining the feasibility and the efficacy of the eResilience App across varied demographics, and a robust framework for investigations of low-cost objective diagnostic markers in mental health interventions. Methodological limitations and suggestions are also provided. Clinical Trial: The study was approved by the Human Research Ethics Committees of the University of Sydney and University of the Sunshine Coast, Australia. It was conducted in compliance with ethics committee approval conditions, the National Health and Medical Research Council’s Statement on Ethical Conduct in Human Research (2007) and the Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95). Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616001205426. Universal Trial Number (UTN): U1111-1180-0347