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

• Published in: JMIR Research Protocols
• Main Authors: Seon, Quinta, Mady, Noor, Yang, Michelle, Karia, Maharshee, Lashley, Myrna, Sescu, Claudia, Lalonde, Maud, Puskas, Stephen, Outerbridge, Joy, Parent-Racine, Echo, Pagiatakis, Catherine, Gomez-Cardona, Liliana, Jiang, Di, Bouchard, Stéphane, Linnaranta, Outi
• Format: Text
• Language: English
• Published: JMIR Publications 2023
• Subjects: Protocol; inuit
• Online Access: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10248771/; http://www.ncbi.nlm.nih.gov/pubmed/37223973; https://doi.org/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. 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 ...