Garvert Mona M, McFadyen Jessica, Linke Stuart, McCloud Tayla, Meyer Sofie S, Sobanska Sandra, Sharp Paul B, Long Alex, Huys Quentin J M, Ahmadi Mandana
Alena, London, United Kingdom.
J Med Internet Res. 2025 Apr 10;27:e64138. doi: 10.2196/64138.
Social anxiety disorder is a common mental health condition characterized by an intense fear of social situations that can lead to significant impairment in daily life. Cognitive behavioral therapy (CBT) has been recognized as an effective treatment; however, access to therapists is limited, and the fear of interacting with therapists can delay treatment seeking. Furthermore, not all individuals respond. Tailoring modular treatments to individual cognitive profiles may improve efficacy. We developed a novel digital adaptation of CBT for social anxiety that is both modular and fully digital without a therapist in the loop and implemented it in the smartphone app Alena.
This study aimed to evaluate the safety, acceptability, and efficacy of the new treatment in online participants with symptoms of social anxiety.
In total, 2 web-based randomized controlled trials (RCTs) comparing individuals with access to the treatment through the app to a waitlist control group were conducted. Participants were recruited on the web and reported Social Phobia Inventory (SPIN) total scores of ≥30. Primary outcomes were safety and efficacy over 6 weeks in 102 women aged 18 to 35 years (RCT 1) and symptom reduction (SPIN scores) after 8 weeks in 248 men and women aged 18 to 75 years (RCT 2).
In RCT 1, active and control arm adverse event frequency and severity were not distinguishable (intervention: 7/52, 13%; waitlist control: 8/50, 16%; χ=0.007; P=.93). App acceptability was high, with a median completion rate of 90.91% (IQR 54.55%-100%). Secondary outcomes suggested greater symptom reduction in the active arm (mean SPIN score reduction -9.83, SD 12.80) than in the control arm (mean SPIN score reduction -4.13, SD 11.59; t=-2.23; false discovery rate P=.04; Cohen d=0.47). RCT 2 replicated these findings. Adverse event frequency was comparable across the 2 groups (intervention: 20/124, 16.1%; waitlist control: 21/124, 16.8%; χ<0.001; P>.99). Despite a longer treatment program, median completion remained high (84.85%, IQR 51.52%-96.97%). SPIN score reduction was greater in the active arm (mean -12.89, SD 13.87) than in the control arm (mean -7.48, SD 12.24; t=-3.13; false discovery rate P=.008; Cohen d=0.42).
The web-only, modular social anxiety CBT program appeared safe, acceptable, and efficacious in 2 independent RCTs on online patient groups with self-reported symptoms of social anxiety.
ClinicalTrials.gov NCT05858294; https://clinicaltrials.gov/study/NCT05858294 (RCT 1) and ClinicalTrials.gov NCT05987969; https://clinicaltrials.gov/study/NCT05987969 (RCT 2).
社交焦虑障碍是一种常见的心理健康状况，其特征是对社交场合存在强烈恐惧，这可能导致日常生活受到严重影响。认知行为疗法（CBT）已被公认为一种有效的治疗方法；然而，能够接触到治疗师的机会有限，而且与治疗师互动的恐惧可能会延迟寻求治疗。此外，并非所有个体都有反应。根据个体认知特征量身定制模块化治疗可能会提高疗效。我们开发了一种针对社交焦虑的新型数字化CBT疗法，它既是模块化的，又完全数字化，无需治疗师参与，并将其应用于智能手机应用程序Alena中。
本研究旨在评估这种新疗法对有社交焦虑症状的在线参与者的安全性、可接受性和疗效。
总共进行了2项基于网络的随机对照试验（RCT），将通过该应用程序获得治疗的个体与等待名单对照组进行比较。参与者通过网络招募，报告社交恐惧症量表（SPIN）总分≥30。主要结局是102名年龄在18至35岁的女性在6周内的安全性和疗效（RCT 1），以及248名年龄在18至75岁的男性和女性在8周后的症状减轻情况（SPIN评分）（RCT 2）。
在RCT 1中，治疗组和对照组不良事件的频率和严重程度没有明显差异（干预组：7/52，13%；等待名单对照组：8/50，16%；χ=0.007；P=.93）。应用程序的可接受性很高，中位完成率为90.91%（四分位间距54.55%-100%）。次要结局表明，治疗组的症状减轻程度（平均SPIN评分降低-9.83，标准差12.80）大于对照组（平均SPIN评分降低-4.13，标准差11.59；t=-2.23；错误发现率P=.04；Cohen d=0.47）。RCT 2重复了这些发现。两组的不良事件频率相当（干预组：20/124，16.1%；等待名单对照组：21/124，16.8%；χ<0.001；P>.99）。尽管治疗方案更长，但中位完成率仍然很高（84.85%，四分位间距51.52%-96.97%）。治疗组的SPIN评分降低幅度（平均-12.89，标准差13.87）大于对照组（平均-7.48，标准差12.24；t=-3.13；错误发现率P=.008；Cohen d=0.42）。
仅通过网络的模块化社交焦虑CBT程序在两项针对有自我报告社交焦虑症状的在线患者群体的独立RCT中显示出安全、可接受且有效。
ClinicalTrials.gov NCT05858294；https://clinicaltrials.gov/study/NCT05858294（RCT 1）和ClinicalTrials.gov NCT05987969；https://clinicaltrials.gov/study/NCT05987969（RCT 2）。
