■精神卫生服务的需求和可用性之间存在巨大差距。数字心理健康干预(DMHI)是弥合这一差距的有希望的工具,然而,人们对它们的相对有效性知之甚少。
■评估随机接受基于认知行为疗法(CBT)或基于正念的DMHI的患者是否比随机接受增强个性化反馈(EPF)的患者在心理健康症状方面有更大的改善。
■设置,和参与者这项随机临床试验于2020年5月13日至2022年12月12日进行,随访6周。招募了密歇根大学卫生系统内各个诊所的门诊精神病学服务的成年患者,并定期或最近进行了门诊精神病学预约。符合条件的患者被随机分配到干预组。所有分析都遵循意向治疗原则。
■参与者被随机分配到5个干预组中的1个:(1)仅限EPF;(2)仅限Silvercloud,旨在提供CBT策略的移动应用程序;(3)Silvercloud加EPF;(4)仅头空间,旨在训练用户进行正念练习的移动应用程序;(5)Headspace加EPF。
■主要结果是患者健康问卷-9(PHQ-9;评分范围:0-27,评分越高表示抑郁症状)所测量的抑郁症状的变化。次要结果包括焦虑的变化,自杀,和物质使用症状。
■总共2079名参与者(平均[SD]年龄,36.8[14.3]年;1423名自我认定为女性[68.4%])完成了基线调查。基线平均(SD)PHQ-9评分为12.7(6.4),所有5个干预组在6周时均显着降低(从-2.1[95%CI,-2.6至-1.7]至-2.9[95%CI,-3.4至-2.4];n=1885)。5臂之间的变化幅度没有显着差异(F4,1879=1.19;P=0.31)。此外,两组在焦虑或药物使用症状减轻方面没有差异.然而,与Silvercloud臂相比,顶部空间臂在自杀性测量子量表上的改善明显更大(平均变化差异=0.63;95%CI,0.20-1.06;P=.004)。
■这项随机临床试验发现,所有DMHI的抑郁和焦虑症状都有所减少,并且很少有证据表明特定应用优于其他应用。研究结果表明,DMHI可以在与等待列表相关的护理延迟期间为患者提供支持。
■ClinicalTrials.gov标识符:NCT04342494。
UNASSIGNED: There is a substantial gap between demand for and availability of mental health services. Digital mental health interventions (DMHIs) are promising tools for bridging this gap, yet little is known about their comparative effectiveness.
UNASSIGNED: To assess whether patients randomized to a cognitive behavioral therapy (CBT)-based or mindfulness-based DMHI had greater improvements in mental health symptoms than patients randomized to the enhanced personalized feedback (EPF)-only DMHI.
UNASSIGNED: SETTING, AND PARTICIPANTS This randomized clinical trial was conducted between May 13, 2020, and December 12, 2022, with follow-up at 6 weeks. Adult patients of outpatient psychiatry services across various clinics within the University of Michigan Health System with a scheduled or recent outpatient psychiatry appointment were recruited. Eligible patients were randomized to an intervention arm. All analyses followed the intent-to-treat principle.
UNASSIGNED: Participants were randomized to 1 of 5 intervention arms: (1) EPF only; (2) Silvercloud only, a mobile application designed to deliver CBT strategies; (3) Silvercloud plus EPF; (4) Headspace only, a mobile application designed to train users in mindfulness practices; and (5) Headspace plus EPF.
UNASSIGNED: The primary outcome was change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9; score range: 0-27, with higher scores indicating greater depression symptoms). Secondary outcomes included changes in anxiety, suicidality, and substance use symptoms.
UNASSIGNED: A total of 2079 participants (mean [SD] age, 36.8 [14.3] years; 1423 self-identified as women [68.4%]) completed the baseline survey. The baseline mean (SD) PHQ-9 score was 12.7 (6.4) and significantly decreased for all 5 intervention arms at 6 weeks (from -2.1 [95% CI, -2.6 to -1.7] to -2.9 [95% CI, -3.4 to -2.4]; n = 1885). The magnitude of change was not significantly different across the 5 arms (F4,1879 = 1.19; P = .31). Additionally, the groups did not differ in decrease in anxiety or substance use symptoms. However, the Headspace arms reported significantly greater improvements on a suicidality measure subscale compared with the Silvercloud arms (mean difference in mean change = 0.63; 95% CI, 0.20-1.06; P = .004).
UNASSIGNED: This randomized clinical trial found decreases in depression and anxiety symptoms across all DMHIs and minimal evidence that specific applications were better than others. The findings suggest that DMHIs may provide support for patients during waiting list-related delays in care.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04342494.