Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, United States.
Department of Communication, Stanford University, Stanford, CA, United States.
JMIR Ment Health. 2024 Apr 15;11:e52326. doi: 10.2196/52326.
Major depressive disorder (MDD) is a global concern with increasing prevalence. While many evidence-based psychotherapies (EBPs) have been identified to treat MDD, there are numerous barriers to patients accessing them. Virtual reality (VR) has been used as a treatment enhancement for a variety of mental health disorders, but few studies have examined its clinical use in treating MDD. Behavioral activation (BA) is a simple yet effective and established first-line EBP for MDD that has the potential to be easily enhanced and adapted with VR technology. A previous report by our group explored the feasibility and acceptability of VR-enhanced BA in a small clinical proof-of-concept pilot. This study examines the clinical efficacy of a more immersive extended reality (XR)-enhanced BA (XR-BA) prototype. This is the first clinical efficacy test of an XR-BA protocol.
This study examined whether XR-BA was feasible and efficacious in treating MDD in an ambulatory telemedicine clinic.
A nonblinded between-subject randomized controlled trial compared XR-BA to traditional BA delivered via telehealth. The study used a previously established, brief 3-week, 4-session BA EBP intervention. The experimental XR-BA participants were directed to use a Meta Quest 2 (Reality Labs) VR headset to engage in simulated pleasant or mastery activities and were compared to a control arm, which used only real-life mastery or pleasant activities as between-session homework. The Patient Health Questionnaire (PHQ)-9 was the primary outcome measure. Independent-sample and paired-sample t tests (2-tailed) were used to determine statistical significance and confirmed using structural equation modeling.
Overall, 26 participants with MDD were randomized to receive either XR-BA (n=13, 50%) or traditional BA (n=13, 50%). The mean age of the 26 participants (n=6, 23% male; n=19, 73% female; n=1, 4% nonbinary or third gender) was 50.3 (SD 17.3) years. No adverse events were reported in either group, and no substantial differences in dropout rates or homework completion were observed. XR-BA was found to be statistically noninferior to traditional BA (t=-0.28; P=.78). Both the XR-BA (t=2.5; P=.04) and traditional BA (t=2.3; P=.04) arms showed a statistically significant decrease in PHQ-9 and clinical severity from the beginning of session 1 to the beginning of session 4. There was a significant decrease in PHQ-8 to PHQ-9 scores between the phone intake and the beginning of session 1 for the XR-BA group (t=2.6; P=.03) but not the traditional BA group (t=1.4; P=.20).
This study confirmed previous findings that XR-BA may be a feasible, non-inferior, and acceptable enhancement to traditional BA. Additionally, there was evidence that supports the potential of XR to enhance expectation or placebo effects. Further research is needed to examine the potential of XR to improve access, outcomes, and barriers to MDD care.
ClinicalTrials.gov NCT05525390; https://clinicaltrials.gov/study/NCT05525390.
重度抑郁症（MDD）是一个全球性问题，其患病率呈上升趋势。虽然已经确定了许多循证心理疗法（EBPs）来治疗 MDD，但患者获得这些疗法的障碍很多。虚拟现实（VR）已被用作各种心理健康障碍的治疗增强手段，但很少有研究探讨其在治疗 MDD 中的临床应用。行为激活（BA）是一种简单但有效的、已确立的一线 MDD EBP，具有通过 VR 技术进行简单增强和适应的潜力。我们小组的先前报告探讨了小型临床概念验证试验中 VR 增强 BA 的可行性和可接受性。本研究检查了更具沉浸感的扩展现实（XR）增强 BA（XR-BA）原型的临床疗效。这是对 XR-BA 方案的首次临床疗效测试。
本研究在远程医疗的门诊环境中，考察 XR-BA 治疗 MDD 是否可行和有效。
一项非盲、受试者间随机对照试验比较了 XR-BA 与通过远程医疗提供的传统 BA。该研究使用了先前建立的、简短的 3 周、4 节的 BA EBP 干预。实验组的 XR-BA 参与者被要求使用 Meta Quest 2（Reality Labs）VR 耳机参与模拟愉快或掌握活动，并与对照组进行比较，对照组仅在现实生活中使用掌握或愉快活动作为会话之间的家庭作业。患者健康问卷（PHQ）-9 是主要的结局衡量标准。采用独立样本和配对样本 t 检验（双侧）确定统计学意义，并使用结构方程模型进行确认。
共有 26 名 MDD 患者被随机分配接受 XR-BA（n=13，50%）或传统 BA（n=13，50%）。26 名参与者（n=6，23%男性；n=19，73%女性；n=1，4%非二元或第三性别）的平均年龄为 50.3（SD 17.3）岁。两组均未报告不良事件，且两组的辍学率或家庭作业完成率无明显差异。XR-BA 在统计学上不比传统 BA 差（t=-0.28；P=.78）。XR-BA（t=2.5；P=.04）和传统 BA（t=2.3；P=.04）组均显示 PHQ-9 和临床严重程度从第 1 次治疗开始到第 4 次治疗开始显著降低。XR-BA 组从电话摄入到第 1 次治疗开始时 PHQ-8 到 PHQ-9 的评分显著降低（t=2.6；P=.03），但传统 BA 组没有（t=1.4；P=.20）。
本研究证实了之前的发现，即 XR-BA 可能是传统 BA 的一种可行、非劣效和可接受的增强手段。此外，有证据表明 XR 有可能增强预期或安慰剂效应。需要进一步研究以探讨 XR 改善 MDD 护理的可及性、结果和障碍的潜力。
ClinicalTrials.gov NCT05525390；https://clinicaltrials.gov/study/NCT05525390。
