ORCID
- Rohit Shankar: 0000-0002-1183-6933
- Edward Meinert: 0000-0003-2484-3347
Abstract
Background: The incidence of mental health concerns is growing, and demand for support is exceeding service capacity.Digital tools can provide additional support but risk causing harm if not delivered safely.Aims: We aimed to establish real-world evidence of the impact of an artificial intelligence-based mental healthconversational agent (Wysa) on depression and anxiety in patients waiting for Talking Therapies treatment.Methods: A mixed-methods randomized controlled trial was conducted with patients referred to Talking Therapies inthe Central and Northwest London NHS Foundation Trust. The primary outcome was change in depression severityover 12weeks between groups; secondary outcomes included anxiety severity, quality of life, safety, engagement, andapp usage. Comparative analyses used linear regression; thematic analysis was conducted on qualitative data.Results: 2,161 patients were screened, 625 were invited, 99 consented, and 76 were randomized (2:1). Thirty patientswere lost to follow-up. Descriptive analysis found that mean differences in depression were similar between arms, butwith large standard deviations (M=2.62, SD=5.07 and 6.56 for Wysa; M=2.59, SD=4.38 and 3.82 for control). Resultswere similar for secondary outcomes. Wysa was potentially helpful, easy to use, and appreciated as an accessible sourceof support, but limitations with the conversational agent negatively affected engagement.Conclusions: Although sample size limited the analysis, participant feedback highlighted its potential to supplementclinical services. Our study findings suggest that the change of depression score is similar in both arms thus indicatingthat there is no evidence that Wysa treats depression in this study. However, limited sample size could have influencedthis. Key lessons to improve the quality of effectiveness studies of digital health technologies were identified.
DOI Link
Publication Date
2026-03-05
Publication Title
International Journal of Social Psychiatry
ISSN
0020-7640
Deposit Date
2026-03-07
Funding
The author disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the National Institute for Health Research (NIHR) and NHSX (Artificial Intelligence in Health and Care Award, AI_AWARD02176). EM, MMI, and AA are supported by the NIHR Newcastle BRC. The views expressed in this publication are those of the author (s) and not necessarily those of the NIHR, NHS, Wysa Limited, or any of the authors’ affiliated universities or BRCs. The funding body was not involved in the study design, data collection or analysis, or the writing and decision to submit the article for publication.
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Recommended Citation
Shankar, R., Meinert, E., Milne-Ives, M., Taylor, E., Inkster, B., Paik, A., Ananthakrishnan, A., Orr, M., & Costelloe, C. (2026) 'Real-World Testing of an Artificial Intelligence Conversational Agent as an Early Intervention and Support Tool in the Mental Health Referral Care Pathway: A Mixed-Methods Study', International Journal of Social Psychiatry, . Available at: 10.1177/00207640251415507
