A Virtual Reality-Assisted Cognitive Behavioral Therapy (VR-CBT) for and with Inuit in Quebec – a protocol for a proof-of-concept randomized controlled trial (Preprint)

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