Anxiety and FearNCT07860034
Trial of a Voice-Based Generative AI Emotional Support Companion
A study testing The intervention was the AI-based emotional support app. and Psychoeducational Material in people with Anxiety and Fear, run by University of Cologne at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety and Fear
- What is being tested?
- The intervention was the AI-based emotional support app. and Psychoeducational Material
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2025to 24 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Office of Sonia Health
San Francisco, California, 94108
About this study
Official title: 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.
- Conditions
- Anxiety and Fear
- Being tested
- The intervention was the AI-based emotional support app., Psychoeducational Material
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention was the AI-based emotional support app.Device
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 MaterialOther
The material consisted of a summary of publicly available information published by the WHO.
| Study group | Role | What they receive |
|---|---|---|
| Sonia Arm | Experimental | This arm got access to the AI-based emotional support app Receives: Device: The intervention was the AI-based emotional support app. |
| Control Group | Placebo comparator | This group received web-based psychoeducational material Receives: Other: Psychoeducational Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalised Anxiety Disorder-7
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).
Measured: 2 weeks
Self-Reported Perception of Safety Relative to Other AI-Chatbots
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start14 Nov 2025
- Primary completion2 Dec 2025
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Sonia Health
- Responsible party
- Principal investigator, Nicolas Roever, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860034
- Sponsor's protocol ID
- 240088NR
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a Voice-Based Generative AI Emotional Support Companion
- ClinicalTrials.gov ID
- NCT07860034
- Acronym / sponsor ID
- 240088NR
- Conditions
- Anxiety and Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Sonia Health
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonia Arm | Experimental | Device: The intervention was the AI-based emotional support app.This arm got access to the AI-based emotional support app |
| Control Group | Placebo comparator | Other: Psychoeducational MaterialThis group received web-based psychoeducational material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Sonia Arm |
| Psychoeducational MaterialThe material consisted of a summary of publicly available information published by the WHO. | Other | Control Group |
Primary outcome
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention was the AI-based emotional support app. and Psychoeducational Material in people with Anxiety and Fear, run by University of Cologne at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalised Anxiety Disorder-7 (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.