The Safety, Acceptability and Efficacy of Alena , a Modularized CBT-based Mobile App Intervention for Social Anxiety: a Randomised Controlled Trial

Social anxiety disorder is a debilitating mental health condition characterized by intense fear of social situations that can significantly impair daily life if left untreated. Cognitive behavioral therapy (CBT) is an effective treatment, but many patients experience slow progress, possibly due to the heterogeneity of cognitive dysfunction contributing to the maintenance of the disease that is not adequately reflected in a typical one-size-fits-all CBT approach. In addition, many patients only seek treatment late, because human therapists can themselves constitute phobic stimuli. To address these challenges, we developed Alena, a digital CBT program based on the Clark and Wells model of social anxiety (Clark and Wells, 1995) that was reorganized to target the four key cognitive functions associated with the maintenance of social anxiety disorder in separate therapy modules: negative beliefs, self-directed attention, rumination, and avoidance behaviors. Here, we tested the safety, acceptability and efficacy of this therapy program. In a randomized controlled trial, primary outcomes showed the app to be safe and acceptable. Secondary endpoint analyses showed that SPIN scores were significantly reduced in the treatment compared to the control group, and a larger number of participants who completed the four-week digital CBT program showed a reliable reduction in their social anxiety scores compared to a waitlist control group. Our findings suggest that targeted digital CBT without therapist involvement was safe, acceptable and showed promising signs of rapid efficacy in the treatment of social anxiety disorder.