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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

BACKGROUND Emotion regulation is an ability related to psychological well-being; when dysregulated, individuals may have psychiatric symptoms and maladapted physiological responses. Cognitive behavioural therapy combined with virtual reality (VR-CBT or CBT-VR) is an effective psychotherapy to target and strengthen emotion regulation, but currently lacks cultural sensitivity and could be improved by adapting it to the cultural context of service users. OBJECTIVE We describe a protocol for a proof-of-concept two-arm randomized controlled trial (RCT) with n=40 Inuit in Quebec. METHODS In a ten-week intervention, Inuit aged 14-60 will receive a culturally adapted VR-CBT with biofeedback or self-guided VR relaxation program. The trial will assess emotion regulation with objective and subjective measures at baseline, throughout and after the treatment and at a 3-month follow-up. The primary outcome is measured by the Difficulties in Emotion Regulation Scale (DERS-16) and a novel psychophysiological reactivity paradigm. Secondary measures include psychological symptoms and wellbeing via rating scales. RESULTS NA CONCLUSIONS The proposed study responds to community desire for accessible and appropriate resources for psychological well-being, as it was developed in active collaboration with the Inuit community in Quebec. We compare a culturally adapted psychotherapy to a commercial self-management program, incorporate novel technology and measurement, and fulfill needs for RCT evidence of culturally adapted psychotherapies. CLINICALTRIAL ISRCTN, ISRCTN21831510, registered 29 April 2022, https://www.isrctn.com/ISRCTN21831510