Trial of a Voice-Based Generative AI Emotional Support Companion
A Randomised Controlled Trial of a Voice-Based Generative AI Emotional Support Companion
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94108
- Office of Sonia Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Uses an iPhone running iOS 18 or newer to complete the screening survey
- Reports using an iPhone as their primary phone
- Aged 18 years or older
- Currently located in the United States and a US resident
- Not currently receiving psychological therapy
- Reports less than "very" or "extremely" concerned about privacy when using AI for emotional support
- Reports a comfort level of at least 50 on a 0-100 scale for using AI for emotional support
- Generalised Anxiety Disorder-7 (GAD-7) score between 13 and 20, inclusive
- Successfully completes the phone screening and confirms sufficient time to participate in the study
Exclusion Criteria:*
- Current suicidal ideation identified during the phone screening
- Residence in Nevada or Illinois
- Failure to meet minimum engagement or data-quality criteria during the screening survey, including extremely short completion times inconsistent with attentive participation
- Failure to meet any of the inclusion criteria above
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sonia Arm
This arm got access to 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. |
|
Placebo Comparator: Control Group
This group received web-based psychoeducational material |
The material consisted of a summary of publicly available information published by the WHO. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalised Anxiety Disorder-7
Time Frame: 2 weeks
|
The Generalised Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure of generalised anxiety symptoms, with scores ranging from 0 to 21 and higher scores indicating greater symptom severity (see Spitzer et al. 2006). |
2 weeks
|
|
Self-Reported Perception of Safety Relative to Other AI-Chatbots
Time Frame: 2 weeks
|
Answers to a survey question asking wether the intervention feels safe relative to traditional AI-chatbots (yes/no). If participants answer no, they are asked in an open-text box to explain their reasoning. Summaries of these answers will also be reported. |
2 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 240088NR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
We will share data from our surveys using a github repository. However, this data is sufficiently sparse so that no individual can be identified from it.
IPD Sharing Time Frame
Available from September 2026
IPD Sharing Access Criteria
Publicly available
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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