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
Department of Psychiatry, McGill University, Montreal, QC, Canada.
Douglas Mental Health University Institute, Montreal, QC, Canada.
JMIR Res Protoc. 2023 May 24;12:e40236. doi: 10.2196/40236.
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.
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.
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).
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.
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.
International Standard Randomized Controlled Trial Number (ISRCTN) 21831510; https://www.isrctn.com/ISRCTN21831510.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40236.
情绪调节是一种与心理健康相关的能力；当调节失调时，个体可能会出现精神症状和适应不良的生理反应。虚拟现实辅助认知行为疗法（VR-CBT）是一种针对并强化情绪调节的有效心理治疗方法；然而，它目前缺乏文化敏感性，可以通过使其适应服务对象的文化背景来加以改进。在之前的参与式研究中，我们共同设计了一本经过文化调适的认知行为疗法（CBT）手册和两个虚拟现实（VR）环境，作为因纽特人心理治疗（VR-CBT）的补充，这些因纽特人希望获得心理治疗服务。情绪调节技能的培养将在具有诸如心率生物反馈等交互组件的虚拟环境中进行。
我们描述了一项针对魁北克因纽特人（n = 40）的概念验证双臂随机对照试验（RCT）方案。本研究的主要目的是调查经过文化调适的VR-CBT干预与市售的既定VR自我管理方法相比的可行性、益处和挑战。我们还将调查自我报告的心理健康状况和客观的心理生理测量指标。最后，我们将使用概念验证数据来确定合适的主要结局指标，在更大规模的疗效试验中进行效能计算，并收集关于现场治疗或居家治疗偏好的信息。
试验参与者将按1:1的比例随机分配到主动治疗组或主动对照组。14至60岁的因纽特人将在10周内接受经过文化调适且有治疗师指导的带生物反馈的VR-CBT，或接受带有非个性化指导组件的VR放松程序。我们将收集治疗前后的情绪调节测量指标，并在治疗期间和3个月随访时每两周进行一次评估。主要结局将通过情绪调节困难量表（DERS-16）和一种新的心理生理反应范式来测量。次要测量指标包括通过量表（如焦虑或抑郁症状）评估的心理症状和幸福感。
由于这是一项RCT方案的前瞻性注册，我们尚未报告该试验的任何结果。资金于2020年1月得到确认，预计招募工作将于2023年3月开始，并于2025年8月结束。预期结果将于2026年春季发表。
拟议的研究回应了社区对获得可及且合适的心理健康资源的需求，因为它是与魁北克的因纽特社区积极合作开展的。我们将通过比较经过文化调适的现场心理治疗与商业自我管理方案来测试可行性和可接受性，同时在原住民健康领域纳入新技术和测量方法。我们还旨在满足加拿大缺乏经过文化调适的心理治疗的RCT证据这一需求。
国际标准随机对照试验编号（ISRCTN）21831510；https://www.isrctn.com/ISRCTN21831510。
国际注册报告识别码（IRRID）：PRR1-10.2196/40236。
