Therapeutic AllianceAASPNCT07777224
AI Ambient Scribe in Psychiatry
A study testing Artificial Intelligence Ambient Scribe in people with Therapeutic Alliance and Empathy, run by Psychiatrie St. Gallen at 8 sites in Switzerland.
Trial summary
The goal of this clinical trial is to learn if an artificial intelligence (AI) tool that listens to appointments and drafts clinical notes can help clinicians in psychiatric care. Researchers also want to know if the tool changes how patients experience their care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Alliance, Empathy, Documentation
- What is being tested?
- Artificial Intelligence Ambient Scribe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 8 sitesSwitzerland
- Study dates
- 13 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
The observed study population comprises mental health care providers (physicians, psychologists/psychotherapists, nurses, and social workers) employed at Psychiatrie St. Gallen.
Provider Inclusion Criteria:
- Readiness to use an artificial intelligence ambient scribe during patient consultations (intervention group)
- Regular clinical consultations with adult psychiatric patients
Two outcome-specific criteria apply: contribution to the report quality outcomes requires that the provider regularly conducts new-patient intakes and writes initial psychiatric assessment reports; contribution to the patient-reported outcomes requires working in the outpatient setting. Providers who cannot or no longer wish to contribute to any actively collected outcome may, with their consent, remain enrolled for passive documentation-time measurement only; for analysis, such providers stay in the group which was fixed at enrollment..
Provider Exclusion Criteria:
- notice of termination of the employment contract given during the data collection period
- Working in the dementia inpatient clinic
Patients are not the observed population, but anonymous ratings of their subjective consultation experience are collected from them, and written consent for the review of initial assessment reports is obtained.
Patient Inclusion Criteria:
- All adult patients visiting the outpatient clinic during the data collection periods for a consultation with a participating provider
Patient Exclusion Criteria:
- Insufficient German proficiency (below level B2)
- Cognitive impairment precluding informed participation
- Acute psychosis, acute suicidality, mania, or intoxication
- Severe emotional distress
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Switzerland8 sites
Psychiatrie St. Gallen
Heerbrugg, Canton of St. Gallen, 9435
Psychiatrie St. Gallen
Pfäfers Dorf, Canton of St. Gallen, 7312
Psychiatrie St. Gallen
Rorschach, Canton of St. Gallen, 9400
Psychiatrie St. Gallen
Sankt Gallen, Canton of St. Gallen, 9000
Psychiatrie St. Gallen
Sargans, Canton of St. Gallen, 7320
Psychiatrie St. Gallen
Uznach, Canton of St. Gallen, 8730
Psychiatrie St. Gallen
Wattwil, Canton of St. Gallen, 9630
Psychiatrie St. Gallen
Wil, Canton of St. Gallen, 9500
About this study
Official title: Evaluating the Use of an Artificial Intelligence Ambient Scribe in a Swiss Psychiatric Clinic: Efficiency, Documentation Quality, and Therapeutic Alliance
The goal of this clinical trial is to learn if an artificial intelligence (AI) tool that listens to appointments and drafts clinical notes can help clinicians in psychiatric care. Researchers also want to know if the tool changes how patients experience their care. The study includes mental health care providers (physicians, psychologists/psychotherapists, nurses, and social workers) at Psychiatrie St. Gallen and the adult patients they see in their appointments.
The main questions it aims to answer are:
Read more
- Does the AI tool lower the time clinicians spend writing notes?
- Are notes written with the AI tool as good as or better than notes written without it?
- Do patients notice a difference in their relationship with their clinician when the tool is used?
Researchers will compare clinicians who use the AI tool to clinicians who keep writing notes their usual way, before and during the intervention period, to see if writing time, note quality, and the patient-rated therapeutic relationship differ between the two groups.
Clinicians will:
Join one of two groups. One group starts using the AI tool on August 14, 2026. The other group keeps writing notes the usual way. Both groups will be observed until the end of November 2026, with note quality evaluation completed in December 2026. Clinicians who cannot contribute to all measurements may, with their consent, remain in the study for automated measurement of documentation time only.
Patients will:
- Be invited to fill out a short, anonymous survey about their experience with their clinician.
- Be asked to agree, in writing, that researchers may review the report from their initial assessment appointment.
- Conditions
- Therapeutic Alliance, Empathy, Documentation, Artificial Intelligence (AI), Efficiency of Physician Documentation, Quality Improvement
- Being tested
- Artificial Intelligence Ambient Scribe
- Keywords
- Artificial Intelligence, Psychiatry, Ambient Scribing
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence Ambient ScribeDevice
Also called Artificial Intelligence
Listener Tool of the SwissGPT application (AlpineAI AG). After the patient's verbal consent, the provider records the consultation audio via mobile phone or laptop. All audio and text data are processed exclusively on AlpineAI's own GPU infrastructure located in Switzerland and are encrypted with individual keys per customer and per data type. Transcription uses the speech-to-text models Whisper 3 Turbo; from the transcript, a draft clinical note is generated by open-weight large language model Mistral Large 3 based on a standardized prompt developed for the institution. The provider transfers the generated draft note unedited into the electronic health record (ORBIS) and performs all review and editing directly in the EHR, so that the effort of correcting AI-generated drafts is captured by the automated documentation-time measurement. Audio recordings and transcripts are automatically deleted after 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The mental health care providers (physicians, psychologists/psychotherapists, nurses, and social workers) in this group document their consultations as usual (typing or conventional dictation), without access to the ambient scribe. Under institutional policy, all clinicians irrespective of study participation may use general-purpose AI tools for administrative and documentation support, provided no patient-identifying data are entered; the control condition is therefore defined as documentation without the ambient scribe, not as documentation without any AI assistance. |
| AI-Group | Experimental | The mental health care providers in this group use an AI ambient scribe to create their clinical notes from consultations, beginning August 14, 2026. Receives: Device: Artificial Intelligence Ambient Scribe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent on psychiatric documentation
Mean minutes spent writing clinical notes (progress notes, initial psychiatric assessment reports, and discharge letters), extracted automatically from EHR (ORBIS) audit logs as form-level editing durations, compared pre-intervention vs. during intervention between groups.
Measured: 24 Weeks
Documentation quality of initial psychiatric asessment reports
Quality of initial psychiatric assessment reports rated with the Physician Documentation Quality Instrument, 9-item version (PDQI-9). Each of the 9 items is scored on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree) and summed to a total score ranging from 9 (minimum) to 45 (maximum); higher scores indicate better documentation quality. Each report is independently rated by 2 of 8 experienced mental health specialists in a balanced rotating-pair design, blinded to provider identity, group, time point, and site.
Measured: 24 Weeks
Working Alliance
Patient-rated working alliance measured with the Working Alliance Inventory-Short Revised, German patient version (WAI-SR). The 12 items are each scored on a 5-point scale (1 to 5) and summed to a total score ranging from 12 (minimum) to 60 (maximum); higher scores indicate a stronger (better) working alliance. Reported anonymously by patients after outpatient consultations. In addition to the two-sided superiority test, non-inferiority is prespecified: a lower bound of the two-sided 95% CI of the difference-in-differences estimate above -3.5 WAI-SR sum-scale points will be interpreted as evidence against a clinically relevant deterioration of the alliance.
Measured: 5 weeks pre intervention and 5 weeks during the intervention.
Secondary outcomes (5)
Time passed from initial psychiatric assessment note creation to its completion
Calendar time from the administrative creation of the initial psychiatric assessment note in the EHR to its completion, capturing documentation backlog. This outcome is separate from total active time spent writing the note.
Measured: 24 Weeks
Guideline-relevant information coverage and density in initial psychiatric assessment reports
Coverage and density of guideline-relevant psychiatric assessment content, scored by a large language model (SwissGPT) against a 71-item checklist derived from the American Psychiatric Association practice guidelines for the psychiatric evaluation of adults. Each item is scored as covered (1), partially covered (0.5), or not covered (0); report length in characters is used to compute information density.
Measured: 24 Weeks
Patient-perceived empathy of mental health care providers during consultations
Patient-perceived empathy measured with the Consultation and Relational Empathy (CARE) measure. The 10 items are each scored on a 5-point scale (1 = poor to 5 = excellent) and summed to a total score ranging from 10 (minimum) to 50 (maximum); higher scores indicate greater perceived empathy (better). Completed anonymously by patients alongside the WAI-SR. A study-specific German translation is used; its psychometric properties will be examined and reported.
Measured: 5 weeks pre intervention and 5 weeks during the intervention.
Documentation quality of ambient scribe-generated initial psychiatric assessment reports (raw AI output)
AI-generated initial psychiatric assessment reports, exactly as produced by the ambient scribe and before any human correction, rated by the generating providers (intervention group only) with the Provider Documentation Summarization Quality Instrument (PDSQI-9), an LLM-adapted 9-attribute instrument screening for hallucinations, omissions, redundancy, and biased language. Each attribute is scored on a 5-point scale (1 to 5) and summed to a total score ranging from 9 (minimum) to 45 (maximum); higher scores indicate better quality of the AI-generated summary.
Measured: 15 Weeks
Clinician Burnout
Work-related burnout of participating providers in both groups, measured with the German version of the Burnout Assessment Tool (BAT). The 23 core-symptom items (subscales: exhaustion, mental distance, cognitive impairment, emotional impairment) are each scored on a 5-point frequency scale (1 = never to 5 = always) and averaged to a core score ranging from 1.00 (minimum) to 5.00 (maximum); higher scores indicate more burnout symptoms (worse outcome). The 10 secondary-symptom items are scored and averaged on the same 1.00-5.00 metric, with higher scores likewise indicating a worse outcome.
Measured: 5 weeks in the pre-intervention period and the last Week (Week 15) of the post-intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start13 Jul 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic AllianceStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Nonrandomized, open-label controlled trial with parallel assignment at the level of mental health care providers, analyzed within a difference-in-differences (DiD) framework. Outcomes are measured in both groups before and during the intervention period. Providers group assignment is fixed at enrollment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatrie St. Gallen
- Sponsor type
- Other government
- Collaborators
- University of St.Gallen
- Responsible party
- Principal investigator, Maja Dobelsek, MD, Psychiatrie St. Gallen
- Investigators
- Maja Dobelsek, MD, Principal investigator, Universität St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777224
- Sponsor's protocol ID
- S012026
- Acronym
- AASP
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of an Artificial Intelligence Ambient Scribe in a Swiss Psychiatric Clinic: Efficiency, Documentation Quality, and Therapeutic Alliance
- ClinicalTrials.gov ID
- NCT07777224
- Acronym / sponsor ID
- AASP / S012026
- Conditions
- Therapeutic Alliance, Empathy, Documentation, Artificial Intelligence (AI), Efficiency of Physician Documentation, Quality Improvement
- Keywords
- Artificial Intelligence, Psychiatry, Ambient Scribing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Psychiatrie St. GallenOther government
- Collaborators
- University of St.Gallen
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Aug 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 goal of this clinical trial is to learn if an artificial intelligence (AI) tool that listens to appointments and drafts clinical notes can help clinicians in psychiatric care. Researchers also want to know if the tool changes how patients experience their care. The study includes mental health care providers (physicians, psychologists/psychotherapists, nurses, and social workers) at Psychiatrie St. Gallen and the adult patients they see in their appointments.
The main questions it aims to answer are:
- Does the AI tool lower the time clinicians spend writing notes?
- Are notes written with the AI tool as good as or better than notes written without it?
- Do patients notice a difference in their relationship with their clinician when the tool is used?
Researchers will compare clinicians who use the AI tool to clinicians who keep writing notes their usual way, before and during the intervention period, to see if writing time, note quality, and the patient-rated therapeutic relationship differ between the two groups.
Clinicians will:
Join one of two groups. One group starts using the AI tool on August 14, 2026. The other group keeps writing notes the usual way. Both groups will be observed until the end of November 2026, with note quality evaluation completed in December 2026. Clinicians who cannot contribute to all measurements may, with their consent, remain in the study for automated measurement of documentation time only.
Patients will:
- Be invited to fill out a short, anonymous survey about their experience with their clinician.
- Be asked to agree, in writing, that researchers may review the report from their initial assessment appointment.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Nonrandomized, open-label controlled trial with parallel assignment at the level of mental health care providers, analyzed within a difference-in-differences (DiD) framework. Outcomes are measured in both groups before and during the intervention period. Providers group assignment is fixed at enrollment.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The mental health care providers (physicians, psychologists/psychotherapists, nurses, and social workers) in this group document their consultations as usual (typing or conventional dictation), without access to the ambient scribe. Under institutional policy, all clinicians irrespective of study participation may use general-purpose AI tools for administrative and documentation support, provided no patient-identifying data are entered; the control condition is therefore defined as documentation without the ambient scribe, not as documentation without any AI assistance. |
| AI-Group | Experimental | Device: Artificial Intelligence Ambient ScribeThe mental health care providers in this group use an AI ambient scribe to create their clinical notes from consultations, beginning August 14, 2026. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Artificial Intelligence Ambient ScribeAlso: Artificial IntelligenceListener Tool of the SwissGPT application (AlpineAI AG). After the patient's verbal consent, the provider records the consultation audio via mobile phone or laptop. All audio and text data are processed exclusively on AlpineAI's own GPU infrastructure located in Switzerland and are encrypted with individual keys per customer and per data type. Transcription uses the speech-to-text models Whisper 3 Turbo; from the transcript, a draft clinical note is generated by open-weight large language model Mistral Large 3 based on a standardized prompt developed for the institution. The provider transfers the generated draft note unedited into the electronic health record (ORBIS) and performs all review and editing directly in the EHR, so that the effort of correcting AI-generated drafts is captured by the automated documentation-time measurement. Audio recordings and transcripts are automatically deleted after 30 days. | Device | AI-Group |
Primary outcome
Time spent on psychiatric documentation
Time frame: 24 Weeks
Mean minutes spent writing clinical notes (progress notes, initial psychiatric assessment reports, and discharge letters), extracted automatically from EHR (ORBIS) audit logs as form-level editing durations, compared pre-intervention vs. during intervention between groups.
Documentation quality of initial psychiatric asessment reports
Time frame: 24 Weeks
Quality of initial psychiatric assessment reports rated with the Physician Documentation Quality Instrument, 9-item version (PDQI-9). Each of the 9 items is scored on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree) and summed to a total score ranging from 9 (minimum) to 45 (maximum); higher scores indicate better documentation quality. Each report is independently rated by 2 of 8 experienced mental health specialists in a balanced rotating-pair design, blinded to provider identity, group, time point, and site.
Working Alliance
Time frame: 5 weeks pre intervention and 5 weeks during the intervention.
Patient-rated working alliance measured with the Working Alliance Inventory-Short Revised, German patient version (WAI-SR). The 12 items are each scored on a 5-point scale (1 to 5) and summed to a total score ranging from 12 (minimum) to 60 (maximum); higher scores indicate a stronger (better) working alliance. Reported anonymously by patients after outpatient consultations. In addition to the two-sided superiority test, non-inferiority is prespecified: a lower bound of the two-sided 95% CI of the difference-in-differences estimate above -3.5 WAI-SR sum-scale points will be interpreted as evidence against a clinically relevant deterioration of the alliance.
5 secondary outcomes
Time passed from initial psychiatric assessment note creation to its completion
Time frame: 24 Weeks
Guideline-relevant information coverage and density in initial psychiatric assessment reports
Time frame: 24 Weeks
Patient-perceived empathy of mental health care providers during consultations
Time frame: 5 weeks pre intervention and 5 weeks during the intervention.
Documentation quality of ambient scribe-generated initial psychiatric assessment reports (raw AI output)
Time frame: 15 Weeks
Clinician Burnout
Time frame: 5 weeks in the pre-intervention period and the last Week (Week 15) of the post-intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Maja Dobelsek, MD principal investigator
Universität St. Gallen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence Ambient Scribe in people with Therapeutic Alliance and Empathy, run by Psychiatrie St. Gallen at 8 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time spent on psychiatric documentation (time frame: 24 Weeks). The study lists 3 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 20 Aug 2026.