Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.
Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.
JAMA Psychiatry. 2021 Jul 1;78(7):705-713. doi: 10.1001/jamapsychiatry.2021.0469.
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.
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.
ICBT and ISUPPORT, both including 10 online modules, 5 separate parental modules, and 3 video call sessions with a therapist.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT03247075.
社交焦虑障碍(SAD)是一种常见的儿童期发病障碍,与终生逆境和个人及整个社会的高成本相关。认知行为疗法(CBT)是一种已确立的治疗 SAD 的循证治疗方法,但可用性有限。
评估治疗师指导的互联网认知行为疗法(ICBT)与积极对照(互联网支持治疗[ISUPPORT])相比,在青少年 SAD 中的疗效和成本效益。
设计、设置和参与者:这是一项单盲、优势随机临床试验,参与者在瑞典斯德哥尔摩的儿童和青少年心理健康服务机构内的临床研究单位招募,招募时间为 2017 年 9 月 1 日至 2018 年 10 月 31 日。最后一名参与者在 2019 年 5 月达到 3 个月随访(主要终点)。包括患有 SAD 主要诊断的 10 至 17 岁儿童和青少年及其父母。
ICBT 和 ISUPPORT,均包括 10 个在线模块、5 个单独的家长模块和 3 次与治疗师的视频通话。
由蒙面评估者在治疗结束后 3 个月评估临床严重程度评分(CSR),源自焦虑症访谈量表。CSR 范围为 0 至 8,得分 4 或更高表示患有病例。次要结局包括蒙面评估者评定的 SAD 和总体功能的诊断状态、儿童和家长报告的社交焦虑和抑郁症状、以及与健康相关的成本。
共有 307 名接受评估的青少年符合条件,其中 103 名被随机分配接受 10 周治疗师指导的 ICBT(n = 51)或治疗师指导的 ISUPPORT(n = 52)治疗 SAD。该样本由 103 名青少年组成(平均[标准差]年龄,14.1[2.1]岁;79[77%]女性)。与 ISUPPORT 相比,互联网认知行为疗法在减轻 SAD 症状严重程度方面更有效。ICBT 的基线和 3 个月随访时的平均(SD)CSR 评分分别为 5.06(0.95)和 3.96(1.46),而 ISUPPORT 的评分分别为 4.94(0.94)和 4.48(1.30)。在 3 个月随访时,存在显著的组间效应大小 d = 0.67(95%置信区间,0.21-1.12)。同样,除了儿童评定的生活质量(无统计学意义)外,所有次要结局衡量指标都显示出显著差异,且具有小到中等的效应大小。成本效益分析表明,与 ISUPPORT 相比,ICBT 具有成本效益,节省的主要驱动因素是较低的药物治疗费用(z = 2.38,P = .02)和增加的学校生产力(z = 1.99,P = .047)在 ICBT 组。ISUPPORT 组发生 1 例自杀未遂;两组均未发生其他严重不良事件。
在这项随机临床试验中,互联网认知行为疗法是一种有效的、具有成本效益的儿童和青少年 SAD 干预措施。在临床实践中的实施可以显著增加 SAD 有效干预措施的可及性。
ClinicalTrials.gov 标识符:NCT03247075。