Importance Social anxiety disorder (SAD) is a prevalent childhood-onset disorder associated with lifelong adversity and high costs for the individual and society at large. Cognitive behavioral therapy (CBT) is an established evidence-based treatment for SAD, but its availability is limited. Objective To assess the efficacy and cost-effectiveness of therapist-guided internet-delivered cognitive behavioral therapy (ICBT) for SAD in youths vs an active comparator, internet-delivered supportive therapy (ISUPPORT). Design, Setting, and Participants This single-masked, superiority randomized clinical trial enrolled participants at a clinical research unit integrated within the child and adolescent mental health services in Stockholm, Sweden, from September 1, 2017, to October 31, 2018. The final participant reached the 3-month follow-up (primary end point) in May 2019. Children and adolescents 10 to 17 years of age with a principal diagnosis of SAD and their parents were included in the study. Interventions ICBT and ISUPPORT, both including 10 online modules, 5 separate parental modules, and 3 video call sessions with a therapist. Main Outcomes and Measures The Clinician Severity Rating (CSR), derived from the Anxiety Disorder Interview Schedule, rated by masked assessors 3 months after the end of treatment. The CSR ranges from 0 to 8, with scores of 4 or higher indicating caseness. Secondary outcomes included masked assessor-rated diagnostic status of SAD and global functioning, child- and parent-reported social anxiety and depressive symptoms, and health-related costs. Results Of the 307 youths assessed for eligibility, 103 were randomized to 10 weeks of therapist-guided ICBT (n = 51) or therapist-guided ISUPPORT (n = 52) for SAD. The sample consisted of 103 youths (mean [SD] age, 14.1 [2.1] years; 79 [77%] female). Internet-delivered cognitive behavioral therapy was significantly more efficacious than ISUPPORT in reducing the severity of SAD symptoms. Mean (SD) CSR scores for ICBT at baseline and at the 3-month follow-up were 5.06 (0.95) and 3.96 (1.46), respectively, compared with 4.94 (0.94) and 4.48 (1.30) for ISUPPORT. There was a significant between-group effect size of d = 0.67 (95% CI, 0.21-1.12) at the 3-month follow-up. Similarly, all of the secondary outcome measures demonstrated significant differences with small to large effect sizes, except for child-rated quality of life (nonsignificant). The cost-effectiveness analyses indicated cost savings associated with ICBT compared with ISUPPORT, with the main drivers of the savings being lower medication costs (z = 2.38, P = .02) and increased school productivity (z = 1.99, P = .047) in the ICBT group. There was 1 suicide attempt in the ISUPPORT group; no other serious adverse events occurred in either group. Conclusions and Relevance In this randomized clinical trial, internet-delivered cognitive behavioral therapy was an efficacious and cost-effective intervention for children and adolescents with SAD. Implementation in clinical practice could markedly increase the availability of effective interventions for SAD. Trial Registration ClinicalTrials.gov Identifier: NCT03247075.

中文翻译：

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治疗师指导的网络认知行为疗法与网络支持治疗儿童和青少年社交焦虑症：一项随机临床试验。

重要性 社交焦虑症 (SAD) 是一种普遍的儿童期发病障碍，与终生的逆境以及个人和整个社会的高成本有关。认知行为疗法 (CBT) 是一种成熟的基于证据的 SAD 治疗方法，但其可用性有限。目的 评估治疗师指导的互联网提供的认知行为疗法（ICBT）对青少年 SAD 的疗效和成本效益与积极的比较，互联网提供的支持疗法（ISUPPORT）。设计、设置和参与者这项单盲、优效性随机临床试验在 2017 年 9 月 1 日至 2018 年 10 月 31 日期间在瑞典斯德哥尔摩的儿童和青少年心理健康服务整合的临床研究单位招募参与者。最终参与者于 2019 年 5 月完成了 3 个月的随访（主要终点）。主要诊断为 SAD 的 10 至 17 岁的儿童和青少年及其父母被纳入研究。干预 ICBT 和 ISUPPORT，均包括 10 个在线模块、5 个单独的家长模块和 3 个与治疗师的视频通话。主要结果和措施 临床医生严重程度评分 (CSR)，源自焦虑症访谈时间表，由蒙面评估员在治疗结束后 3 个月进行评分。CSR 的范围从 0 到 8，得分为 4 或更高表示 caseness。次要结果包括 SAD 的蒙面评估者评定的诊断状态和整体功能、儿童和父母报告的社交焦虑和抑郁症状，以及与健康相关的费用。结果 在评估合格的 307 名青年中，103 人被随机分配到治疗师指导的 ICBT（n = 51）或治疗师指导的 ISUPPORT（n = 52）治疗 SAD 的 10 周。样本包括 103 名青年（平均 [SD] 年龄，14.1 [2.1] 岁；79 [77%] 女性）。互联网提供的认知行为疗法在减轻 SAD 症状严重程度方面明显比 ISUPPORT 更有效。ICBT 在基线和 3 个月随访时的平均 (SD) CSR 分数分别为 5.06 (0.95) 和 3.96 (1.46)，而 ISUPPORT 为 4.94 (0.94) 和 4.48 (1.30)。在 3 个月的随访中，d = 0.67 (95% CI, 0.21-1.12) 的显着组间效应大小。同样，除了儿童评定的生活质量（不显着）外，所有次要结果测量都显示出从小到大的显着差异。成本效益分析表明，与 ISUPPORT 相比，ICBT 节省了成本，节省的主要驱动因素是降低药物成本（z = 2.38，P = .02）和提高学校生产力（z = 1.99，P = .047）在 ICBT 组。ISUPPORT 组有 1 次自杀未遂；两组均未发生其他严重不良事件。结论和相关性 在这项随机临床试验中，互联网提供的认知行为疗法对患有 SAD 的儿童和青少年来说是一种有效且具有成本效益的干预措施。在临床实践中实施可以显着增加 SAD 有效干预措施的可用性。试验注册 ClinicalTrials.gov 标识符：NCT03247075。38, P = .02) 并提高了 ICBT 组的学校生产力 (z = 1.99, P = .047)。ISUPPORT 组有 1 次自杀未遂；两组均未发生其他严重不良事件。结论和相关性 在这项随机临床试验中，互联网提供的认知行为疗法对患有 SAD 的儿童和青少年来说是一种有效且具有成本效益的干预措施。在临床实践中实施可以显着增加 SAD 有效干预措施的可用性。试验注册 ClinicalTrials.gov 标识符：NCT03247075。38, P = .02) 并提高了 ICBT 组的学校生产力 (z = 1.99, P = .047)。ISUPPORT 组有 1 次自杀未遂；两组均未发生其他严重不良事件。结论和相关性 在这项随机临床试验中，互联网提供的认知行为疗法对患有 SAD 的儿童和青少年来说是一种有效且具有成本效益的干预措施。在临床实践中实施可以显着增加 SAD 有效干预措施的可用性。试验注册 ClinicalTrials.gov 标识符：NCT03247075。互联网提供的认知行为疗法对患有 SAD 的儿童和青少年来说是一种有效且具有成本效益的干预措施。在临床实践中实施可以显着增加 SAD 有效干预措施的可用性。试验注册 ClinicalTrials.gov 标识符：NCT03247075。互联网提供的认知行为疗法对患有 SAD 的儿童和青少年来说是一种有效且具有成本效益的干预措施。在临床实践中实施可以显着增加 SAD 有效干预措施的可用性。试验注册 ClinicalTrials.gov 标识符：NCT03247075。