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Trial of a Voice-Based Generative AI Emotional Support Companion
Sponsor: University of Cologne
Summary
The investigators conduct a randomized controlled trial (RCT) to study an AI-based emotional support app. The focus in this paper is on two main areas: (1) changes in anxiety levels, and (2) safety.
Official title: A Randomised Controlled Trial of a Voice-Based Generative AI Emotional Support Companion
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-11-14
Completion Date
2025-12-24
Last Updated
2026-10-06
Healthy Volunteers
Yes
Conditions
Interventions
The intervention was the AI-based emotional support app.
Sonia is a commercially available voice-based application built around a real-time conversation with a voice generated by artificial intelligence (AI). The application first assesses the user's situation during the initial session and uses this information to create a ''case conceptualisation''. This conceptualisation guides the content and structure of subsequent sessions and is continuously updated as new information emerges. Each of these subsequent sessions is structured around the five standard cognitive behavioural therapy (CBT) building blocks (a mood check, collaborative agenda setting, review of between-session practice, introduction and rehearsal of a specific technique, and a homework assignment). Technically, Sonia uses a reasoning model to create and continuously update the ''case conceptualisation''. The model is prompted to draw on its learned knowledge base when creating or updating the conceptualisation.
Psychoeducational Material
The material consisted of a summary of publicly available information published by the WHO.
Locations (1)
Office of Sonia Health
San Francisco, California, United States