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.

This study was sponsored and funded in full by Alena (Aya Technologies Ltd). Study authors MMG, TM, SSM, SS and AL were employed by Alena at the time of conducting the study and SL is paid on a consultancy basis. MMG, SSM, SS, AL and MA own share options. QJMH is employed by University College London and acknowledges research grant funding from the Wellcome Trust, Carigest S.A. and Koa Health, and fees and share options for consultancies for Aya Technologies Ltd and Alto Neuroscience.

NCT05858294

This study was sponsored and funded in full by Alena (Aya Technologies Ltd).

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Reading Independent Ethics Committee gav ethical approval for this work (study reference: AYSATOL).

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All data produced in the present study are available upon reasonable request to the authors.