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

Andrew Allen; Allan H. Young; Francine C. Jellesma; Anton Vorobev; Evgeniia Ivanova; Nikolay Babakov; Ani Gisnarian; Lee Kannis-Dymand

doi:10.1016/j.jad.2026.121275

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

Journal article

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Peer reviewed

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

Andrew Allen, Allan H. Young, Francine C. Jellesma, Anton Vorobev, Evgeniia Ivanova, Nikolay Babakov, Ani Gisnarian and Lee Kannis-Dymand

Journal of Affective Disorders, Vol.401, pp.1-12

2026

DOI: https://doi.org/10.1016/j.jad.2026.121275

PMID: 41633449

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Abstract

mental health apps

digital health

congitive behaviour therapy

artificial intelligence

depression

anxiety

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.

Details

Title: An exploratory randomized controlled trial of an AI-enabled mental health intervention for generalized anxiety
Authors: Andrew Allen (Corresponding Author) - University of the Sunshine Coast, Queensland, School of Health - Psychology
Allan H. Young - Imperial College London
Francine C. Jellesma
Anton Vorobev
Evgeniia Ivanova
Nikolay Babakov
Ani Gisnarian
Lee Kannis-Dymand - University of the Sunshine Coast, Queensland, School of Health - Psychology
Publication details: Journal of Affective Disorders, Vol.401, pp.1-12
Publisher: Elsevier BV
Date published: 2026
DOI: 10.1016/j.jad.2026.121275
ISSN: 1573-2517
PMID: 41633449
Data Availability: Data can be made available upon reasonable request.
Grant note: Recruitment for this study was funded by Dr. Jay SAS.
Organisation Unit: School of Health - Psychology; Sexual Violence Research and Prevention Unit; Sustainability Research Cluster
Language: English
Record Identifier: 991210067902621
Output Type: Journal article

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