Robinson Noah, Ramos Francisco N, Hollon Steven D, Han Gloria T, Ezawa Iony D
Department of Psychology, Vanderbilt University, Nashville, TN, United States.
Department of Psychology, University of Southern California, Los Angeles, CA, United States.
JMIR Res Protoc. 2025 May 6;14:e65970. doi: 10.2196/65970.
Depression and anxiety are among the most common mental health concerns globally. Efficacious treatments such as cognitive behavioral therapy exist but remain difficult to access and scale. Cognitive behavioral immersion (CBI)-a cognitive behavioral skills training intervention delivered by peer coaches in the metaverse-has been developed to address these barriers. CBI can be used through a virtual reality headset or via flat-screen devices such as phones, tablets, or computers. Pilot data have established its usability among participants with clinical levels of depression and anxiety. However, more research is needed to determine whether CBI causes decreases in these symptoms and how delivery via virtual reality compares to flat-screen devices.
This protocol aims to conduct a randomized controlled trial evaluating the efficacy of immersive CBI accessed via a virtual reality headset (CBI-VR) as compared to a less immersive (but more accessible) CBI condition accessed via a flat-screen device (CBI-FS) and each to a delayed access control (DAC).
A total of 306 adults experiencing clinical levels of depressive symptoms are being recruited nationally to participate in this web-based trial. Participants will be randomized according to a 1:1:1 ratio to one of three conditions: (1) CBI-VR, (2) CBI-FS, and (3) DAC. The CBI program consists of eight weekly 60-minute group sessions led by trained peer coaches who teach cognitive behavioral skills. The acute period of each condition will last 8 weeks with a follow-up period of 6 months. The primary outcome is depressive symptoms; secondary outcomes are anxiety symptoms and quality of life. Outcomes will be assessed once at baseline, weekly during the course of the intervention, and monthly during follow-ups. We will use hierarchical linear models to assess differences in the rate of symptom change among conditions. We will also explore potential prognostic (demographics and immersion) and prescriptive (cognitive behavioral skills, group alliance, and program engagement) predictors, as well as potential mechanisms (cognitive change and social support) of response.
We hypothesize that participants randomized to either CBI group will experience greater symptom improvement than those in DAC and that CBI-VR participants will improve more than CBI-FS participants. This study was funded in September 2023. Data collection began in February 2024. As of January 2025, all 306 participants have been enrolled. Data collection should conclude by September 2025. Data have not yet been analyzed. Expected results to be submitted for publication in the winter of 2025.
This trial will determine if CBI via either device is efficacious as compared to DAC and whether virtual reality enhances outcomes. Findings will contribute to the literature on using the metaverse and virtual reality to facilitate effective accessible mental health interventions, particularly for depression.
ClinicalTrials.gov NCT06418997; https://clinicaltrials.gov/study/NCT06418997.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/65970.
抑郁症和焦虑症是全球最常见的心理健康问题。虽然存在如认知行为疗法等有效治疗方法，但这些方法仍难以获得且难以推广。为解决这些障碍，人们开发了认知行为沉浸式疗法（CBI）——一种由同伴教练在元宇宙中提供的认知行为技能培训干预措施。CBI可通过虚拟现实头显使用，也可通过手机、平板电脑或电脑等平面屏幕设备使用。初步数据已证实其在患有临床水平抑郁症和焦虑症的参与者中的可用性。然而，需要更多研究来确定CBI是否能减轻这些症状，以及通过虚拟现实设备与平面屏幕设备进行治疗的效果对比。
本方案旨在进行一项随机对照试验，评估通过虚拟现实头显进行的沉浸式CBI（CBI-VR）与通过平面屏幕设备进行的沉浸式程度较低（但更易获得）的CBI（CBI-FS）以及各自与延迟接入对照组（DAC）相比的疗效。
全国范围内共招募306名有临床水平抑郁症状的成年人参与这项基于网络的试验。参与者将按1:1:1的比例随机分为三个组：（1）CBI-VR组，（2）CBI-FS组，（3）DAC组。CBI项目包括由经过培训的同伴教练主持的为期八周、每周60分钟的小组课程，教练会教授认知行为技能。每个组的急性期将持续8周，随访期为6个月。主要结局指标是抑郁症状；次要结局指标是焦虑症状和生活质量。结局指标将在基线时评估一次，干预期间每周评估一次，随访期间每月评估一次。我们将使用分层线性模型来评估各组症状变化率的差异。我们还将探索潜在的预后因素（人口统计学和沉浸程度）和处方因素（认知行为技能、小组联盟和项目参与度）预测指标，以及反应的潜在机制（认知改变和社会支持）。
我们假设随机分配到任一CBI组的参与者比DAC组的参与者症状改善更明显，且CBI-VR组的参与者比CBI-FS组的参与者改善更多。本研究于2023年9月获得资助。数据收集于2024年2月开始。截至2025年1月，306名参与者均已入组。数据收集应于2025年9月结束。数据尚未进行分析。预计结果将于2025年冬季提交发表。
本试验将确定与DAC相比，通过任一设备进行的CBI是否有效，以及虚拟现实是否能改善治疗效果。研究结果将为利用元宇宙和虚拟现实促进有效的可及心理健康干预措施，尤其是针对抑郁症的干预措施的文献做出贡献。
ClinicalTrials.gov NCT06418997；https://clinicaltrials.gov/study/NCT06418997。
国际注册报告识别码（IRRID）：DERR1-10.2196/65970。
