An exploratory randomized controlled trial of an AI-enabled mental health intervention for generalized anxiety.

Clinical Snapshot

Key Findings

• P Value: Significant differences reported but specific values not provided

• Effect Size: Medium effect sizes at 2 weeks, moderate to large effect sizes maintained at 12 weeks

• Primary Outcome: GAD-7 anxiety scores significantly lower in intervention group at 2 weeks

• Nnt Or Sensitivity: Not calculable from available data

• Confidence Interval: Not reported

Clinical Application

High feasibility as digital intervention, though significant attrition suggests acceptability challenges requiring further investigation Relevant to Australian mental health landscape given similar healthcare system to UK. Could complement existing digital mental health initiatives and address workforce shortages in psychological services Adults with GAD symptoms in primary care settings, particularly those with limited access to face-to-face psychological therapy

Abstract

Generalized Anxiety Disorder (GAD) is prevalent and often co-occurs with depression, contributing to significant disability and healthcare burden. Although treatments such as CBT and SSRIs are effective, access remains limited. This exploratory, randomized controlled trial evaluated the effectiveness of an AI-powered mental health app (PATH) in reducing symptoms of anxiety and depression. A total of 316 UK-based participants (aged 19-70) were randomized to either the intervention group (PATH) or a control group (NHS self-help website). The intervention provided evidence-based strategies including CBT-informed chat therapy and interactive tools. Anxiety (GAD-7) and depression (PHQ-9) scores were measured at baseline, two, eight, and twelve weeks. Of the 316 randomized participants, 235 completed the post-intervention assessment (33.0% attrition in the intervention group vs. 18.5% in the control group). Retention at 8-week and 12-week follow-ups was 77.4% and 54.0%, respectively. At two weeks, the intervention group showed significantly lower GAD-7 and PHQ-9 scores compared to control, with medium effect sizes. At eight weeks, those who continued using the app showed significant reductions in both anxiety and depression, while those who discontinued still showed medium improvements in anxiety. Effects were maintained at twelve weeks, with moderate to large effect sizes. Findings suggest that PATH significantly reduces anxiety and depressive symptoms, particularly with continued use. These results support the app's potential as a scalable, accessible digital intervention to address mental health treatment gaps.

References

1. 1.Allen, A., Young, A. H., Jellesma, F. C., Vorobev, A., Ivanova, E., Babakov, N., Gisnarian, A., & Kannis-Dymand, L. (2026). An exploratory randomized controlled trial of an AI-enabled mental health intervention for generalized anxiety. Journal of Affective Disorders, 121275. https://doi.org/10.1016/j.jad.2026.121275