A Virtual Reality-Assisted Cognitive Behavioral Therapy for and With Inuit in Québec: Protocol for a Proof-of-Concept Randomized Controlled Trial.

BACKGROUND: Emotion regulation is an ability related to psychological well-being; when dysregulated, individuals may have psychiatric symptoms and maladapted physiological responses. Virtual reality-assisted cognitive behavioral therapy (VR-CBT) is an effective psychotherapy to target and strengthen emotion regulation; however, it currently lacks cultural sensitivity and can be improved by adapting it to the cultural context of service users. During previous participatory research, we co-designed a culturally adapted cognitive behavioral therapy (CBT) manual and 2 virtual reality (VR) environments to function as a complement to therapy (VR-CBT) for Inuit who would like to access psychotherapy. Emotion regulation skill building will occur in virtual environments that have interactive components such as heart rate biofeedback. OBJECTIVE: We describe a protocol for a proof-of-concept 2-arm randomized controlled trial (RCT) with Inuit (n=40) in Québec. The primary aims of this research are to investigate the feasibility, benefits, and challenges of the culturally adapted VR-CBT intervention versus an established VR self-management that is available commercially. We will also investigate self-rated mental well-being and objective psychophysiological measures. Finally, we will use proof-of-concept data to identify suitable primary outcome measures, conduct power calculations in a larger trial for efficacy, and collect information about preferences for on-site or at-home treatment. METHODS: Trial participants will be randomly assigned to an active condition or active control condition in a 1:1 ratio. Inuit aged 14 to 60 years will receive a culturally adapted and therapist-guided VR-CBT with biofeedback or a VR relaxation program with nonpersonalized guided components over a 10-week period. We will collect pre- and posttreatment measures of emotion regulation and biweekly assessments over the treatment and at 3-month follow-up. The primary outcome will be measured by the Difficulties in Emotion Regulation Scale (DERS-16) and a novel psychophysiological reactivity paradigm. Secondary measures include psychological symptoms and well-being via rating scales (eg, anxiety or depressive symptoms). RESULTS: As this is the prospective registration of an RCT protocol, we do not yet report any results from the trial. Funding was confirmed in January 2020, and recruitment is expected to start in March 2023 and is set to finish in August 2025. The expected results are to be published in spring 2026. CONCLUSIONS: The proposed study responds to the community's desire for accessible and appropriate resources for psychological well-being, as it was developed in active collaboration with the Inuit community in Québec. We will test feasibility and acceptance by comparing a culturally adapted, on-site psychotherapy with a commercial self-management program while incorporating novel technology and measurement in the area of Indigenous health. We also aim to fulfill the needs for RCT evidence of culturally adapted psychotherapies that are lacking in Canada. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 21831510; https://www.isrctn.com/ISRCTN21831510. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40236.

VitalSeer: The development of a contactless sensing technology based on a user-centric data-driven clinical approach.

The COVID-19 pandemic presented challenges to the healthcare system while catalyzing the adoption of virtual care. The need for remote assessment and real-time monitoring of physiological vital signs has driven towards a need for virtual care solutions. This paper presents the outcome of a multidisciplinary collaboration to ensure clinical usability of a remote contactless sensing technology, VitalSeer, and to help close gaps between emerging technologies and clinical practice. The paper describes the user-centric data-driven clinical approach to address the needs as identified by clinical experts through the iterative and agile development cycle. It highlights findings from preliminary studies to validate proof-of-concept VitalSeer's adoptability, accessibility and usability. The studies on volunteers demonstrated the accuracy of VitalSeer's heart rate model at a low MAE of 0.74 (bpm) and a RMSE of 1.2 bpm, below the threshold of clinical grade contact-based sensors. The paper concludes with a discussion on the technology implications in emergency medicine and community care.

Effect of stenosis eccentricity on the functionality of coronary bifurcation lesions-a numerical study.

Interventional cardiologists still rely heavily on angiography for the evaluation of coronary lesion severity, despite its poor correlation with the presence of ischemia. In order to improve the accuracy of the current diagnostic procedures, an understanding of the relative influence of geometric characteristics on the induction of ischemia is required. This idea is especially important for coronary bifurcation lesions (CBLs), whose treatment is complex and is associated with high rates of peri- and post-procedural clinical events. Overall, it is unclear which geometric and morphological parameters of CBLs influence the onset of ischemia. More specifically, the effect of stenosis eccentricity is unknown. Computational fluid dynamic simulations, under a geometric multiscale framework, were executed for seven CBL configurations within the left main coronary artery bifurcation. Both concentric and eccentric stenosis profiles of mild to severe constriction were considered. By using a geometric multiscale framework, the fractional flow reserve, which is the gold-standard clinical diagnostic index, could be calculated and was compared between the eccentric and concentric profiles for each case. The results suggested that for configurations where the supplying vessel is stenosed, eccentricity could have a notable effect on and therefore be an important factor that influences configuration functionality.

A numerical investigation of the functionality of coronary bifurcation lesions with respect to lesion configuration and stenosis severity.

The intervention of coronary bifurcation lesions is associated with higher rates of peri- and post-procedural clinical events compared to the treatment of isolated lesions. Overall, the factors that influence the dynamics of these types of configurations are still not well understood. A geometric multiscale model, consisting of a 3D representation of the left main coronary artery bifurcation and a 0D representation of the rest of the cardiovascular system, was developed. Computational fluid dynamics simulations of the 3D domain were executed by implementing the multiscale algorithm, in order to characterize the functionality of different multilesional configurations as a function of stenosis severity. The investigation found that coronary branch steal has a significant impact on the functionality of the disease and can render a two-lesion configuration more severe compared to a three-lesion configuration. As a result of the complexity of this phenomenon, it was also suggested that certain lesion configurations could result in false negatives in diagnosis when employing a pullback pressure recording across the tandem lesions. In conclusion, this study showed that coronary bifurcation lesions are subject to intricate haemodynamic interactions which render the characterization of their functionality complex and could have significant clinical implications with regards to their diagnosis and prognosis.

A comparison between the principal stress direction and collagen fiber orientation in coronary atherosclerotic plaque fibrous caps.

The rupture of coronary atherosclerotic plaque fibrous caps has been associated with acute myocardial infarctions. Collagen fibers, the main structural component of vascular tissue, have been observed to change orientation and align themselves with the principal stress direction. This study compared the principal stress direction in stenosed coronary arteries obtained from 3D fluid-structure interaction simulations to the orientation of collagen fibers in the fibrous cap of human specimens. The principal stress direction at the peak of the stenosis was found to be axially oriented and correlated well with the determined orientation of the collagen fibers in the fibrous cap specimens.

Numerical study of stenotic side branch hemodynamics in true bifurcation lesions.

Coronary bifurcation lesions are complex. Whether a critical condition exists in the stenotic side branch (SB) of bifurcation lesions, according to the Medina classification, is unassessed. Computational models of coronary bifurcations were developed with different stenosis severities and locations, in order to study the flow distribution and wall shear stress (WSS) in the SB. It was found that bifurcation lesion type (1,0,1) had a flow ratio of 0.25, much less than the corresponding normal ratio of 0.47, and the 0.46 and 0.39 ratios computed for lesion types (0,1,1) and (1,1,1), respectively. Bifurcation type (1,0,1) was associated with a 47% reduction from normal coronary flow, resulting in coronary branch steal. Blood flow to the SB decreased as the stenosis severity increased and approached the carina, in the proximal, distal, and side branches. Similarly, WSS values decreased with increasing stenosis severity. Bifurcation type (1,0,1) had the lowest WSS values in the SB, and were below the 0.5Pa threshold for atherosclerotic growth. In conclusion, the results suggest that lesion type (1,0,1) is at the greatest risk of coronary branch steal, leading to potential ischemia, as well as further atherosclerotic growth. This is counterintuitive to the Medina classification, where bifurcation type (1,1,1) is usually considered the most severe.