Department of Developmental Psychology, University of Amsterdam, Amsterdam, Netherlands.
Technical Support Psychology Department, University of Amsterdam, Amsterdam, Netherlands.
JMIR Ment Health. 2024 Jun 19;11:e50503. doi: 10.2196/50503.
Internet-based cognitive behavioral interventions (iCBTs) are efficacious treatments for depression and anxiety. However, it is unknown whether adding human guidance is feasible and beneficial within a large educational setting.
This study aims to potentially demonstrate the superiority of 2 variants of a transdiagnostic iCBT program (human-guided and computer-guided iCBT) over care as usual (CAU) in a large sample of university students and the superiority of human-guided iCBT over computer-guided iCBT.
A total of 801 students with elevated levels of anxiety, depression, or both from a large university in the Netherlands were recruited as participants and randomized to 1 of 3 conditions: human-guided iCBT, computer-guided iCBT, and CAU. The primary outcome measures were depression (Patient Health Questionnaire) and anxiety (Generalized Anxiety Disorder scale). Secondary outcomes included substance use-related problems (Alcohol Use Disorder Identification Test and Drug Abuse Screening Test-10 items). Linear mixed models were used to estimate the effects of time, treatment group, and their interactions (slopes). The primary research question was whether the 3 conditions differed in improvement over 3 time points (baseline, midtreatment, and after treatment) in terms of depression and anxiety symptoms. Results were analyzed according to the intention-to-treat principle using multiple imputation. Patients were followed exploratively from baseline to 6 and 12 months.
In both short-term and long-term analyses, the slopes for the 3 conditions did not differ significantly in terms of depression and anxiety, although both web-based interventions were marginally more efficacious than CAU over 6 months (P values between .02 and .03). All groups showed significant improvement over time (P<.001). For the secondary outcomes, only significant improvements over time (across and not between groups) were found for drug use (P<.001). Significant differences were found in terms of adherence, indicating that participants in the human-guided condition did more sessions than those in the computer-guided condition (P=.002).
The transdiagnostic iCBT program offers a practical, feasible, and efficacious alternative to usual care to tackle mental health problems in a large university setting. There is no indication that human guidance should be preferred over technological guidance. The potential preference of human support also depends on the scale of implementation and cost-effectiveness, which need to be addressed in future trials.
International Clinical Trials Registry Platform NL7328/NTR7544; https://trialsearch.who.int/Trial2.aspx?TrialID=NL-OMON26795.
基于互联网的认知行为干预（iCBT）是治疗抑郁和焦虑的有效方法。然而，在大型教育环境中，增加人工指导是否可行和有益尚不清楚。
本研究旨在通过对荷兰一所大型大学的大量学生进行研究，证明一种跨诊断 iCBT 程序（人工指导和计算机指导 iCBT）的 2 种变体相对于常规护理（CAU）具有潜在优势，以及人工指导 iCBT 优于计算机指导 iCBT。
共招募了 801 名来自荷兰一所大型大学的焦虑、抑郁或两者均有升高的学生作为参与者，并随机分为 3 组：人工指导 iCBT、计算机指导 iCBT 和 CAU。主要结局测量指标为抑郁（患者健康问卷）和焦虑（广泛性焦虑障碍量表）。次要结局指标包括物质使用相关问题（酒精使用障碍识别测试和药物滥用筛查测试-10 项）。使用线性混合模型来估计时间、治疗组及其相互作用（斜率）的影响。主要研究问题是，在 3 个条件下，在抑郁和焦虑症状方面，是否在 3 个时间点（基线、中期治疗和治疗后）的改善程度存在差异。根据意向治疗原则，使用多重插补进行分析。对患者进行探索性随访，从基线到 6 个月和 12 个月。
在短期和长期分析中，3 个条件的斜率在抑郁和焦虑方面没有显著差异，尽管这两种基于网络的干预措施在 6 个月时比 CAU 略有效（P 值在.02 到.03 之间）。所有组在治疗期间都有显著改善（P<.001）。对于次要结局，仅在药物使用方面发现了随着时间的推移（跨组和不跨组）的显著改善（P<.001）。在依从性方面存在显著差异，表明人工指导组的参与者比计算机指导组的参与者完成了更多的疗程（P=.002）。
跨诊断 iCBT 方案为解决大型大学环境中的心理健康问题提供了一种实用、可行且有效的替代常规护理的方法。没有迹象表明人工指导应该优于技术指导。对人工支持的潜在偏好也取决于实施规模和成本效益，这需要在未来的试验中加以解决。
国际临床试验注册平台 NL7328/NTR7544；https://trialsearch.who.int/Trial2.aspx?TrialID=NL-OMON26795。
