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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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San Francisco, California, Forenede Stater, 94108
- Office of Sonia Health
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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. |
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Placebo komparator: Control Group
This group received web-based psychoeducational material |
The material consisted of a summary of publicly available information published by the WHO. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Generalised Anxiety Disorder-7
Tidsramme: 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
|
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Self-Reported Perception of Safety Relative to Other AI-Chatbots
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 240088NR
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
Available from September 2026
IPD-delingsadgangskriterier
Publicly available
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .