ClinicalTrials.gg
Active, not recruitingNCT07777224AASPUpdated Oct 28, 2026

AI Ambient Scribe in Psychiatry

An interventional study of Artificial Intelligence Ambient Scribe in Therapeutic Alliance, Empathy and Documentation, sponsored by Psychiatrie St. Gallen. Active, not recruiting at 8 sites in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Psychiatrie St. Gallen · Not applicable, Interventional, and Health services research

Updated Oct 28, 2026Primary completion movedStudy completion moved+2 moreGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Burnout, Psychological with a site in Switzerland — 7 open to participants now, 8 under way, none of them phase 3. Burnout, Psychological · Switzerland.

Started
2026
with 2 others
No phase
8 of 13
2 open now
Registered
12th of 13
by date
Lead sponsor
1 of 13
Psychiatrie St. Gallen

Among the 13 studies in Burnout, Psychological with a site in Switzerland, this one is one of 3 that started in 2026, is one of 8 with no phase, and was the 12th registered.

Burnout, Psychological

467 studies on the registry are indexed under Burnout, Psychological; 121 are open to participants now.

Browse Burnout, Psychological studies →

Open to participants now

7 of the 13 studies in Burnout, Psychological with a site in Switzerland are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 66 Burnout, Psychological studies recruiting now, 43 (65%) set no upper age limit and 17 (26%) stop at 75 or younger; 15 take children under 18; 34 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Burnout, Psychological with a site in Switzerland, or all of them as a file.
02

Study 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. 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 17, 2026 (7 clinicians whose devices were delivered late start on November 9, 2026). The other group keeps writing notes the usual way. Both groups will be observed until the end of November 2026 (the 7 late-starting clinicians and additional control data collection until February 22, 2027), with note quality evaluation in February and March 2027. 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.

03

Conditions studied

  • Therapeutic Alliance
  • Empathy
  • Documentation
  • Artificial Intelligence (AI)
  • Efficiency of Physician Documentation
  • Quality Improvement
  • Burnout

Keywords

  • Artificial Intelligence
  • Psychiatry
  • Ambient Scribing
04

Who can participate

The criteria were revised on the registry on Oct 28, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
47 participants (actual)

Study arms

  • No intervention
    Control Group

    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.

  • Experimental
    AI-Group

    The mental health care providers in this group use an AI ambient scribe to create their clinical notes from consultations, beginning August 17, 2026, or November 9, 2026, for 7 providers whose mobile devices were delivered late.

    Device: Artificial Intelligence Ambient Scribe

Interventions

  • DeviceArtificial Intelligence Ambient Scribe

    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. It also includes a general-purpose chatbot.

    Also known as: Artificial Intelligence

06

What researchers measure

Primary outcomes

  1. Time spent on psychiatric documentation

    Mean minutes spent writing clinical notes (progress notes, initial psychiatric assessment reports), extracted automatically from EHR (ORBIS) audit logs as form-level editing durations, compared pre-intervention vs. during intervention between groups.

    Time frame: Pre-intervention period (13 weeks; 25 weeks for late-starting providers) and 15-week intervention period.

  2. 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.

    Time frame: Pre-intervention period (13 weeks; 25 weeks for late-starting providers) and 15-week intervention period.

  3. 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. Tests are two-sided; a deterioration margin of -3.5 sum-scale points is prespecified as an interpretive benchmark (not a validated non-inferiority threshold): a lower bound of the two-sided 95% CI of the effect estimate above -3.5 points will be interpreted as evidence against a deterioration of this size.

    Time frame: 5 weeks pre intervention and 5 weeks during the intervention.

Secondary outcomes

  1. 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.

    Time frame: Pre-intervention period (13 weeks; 25 weeks for late-starting providers) and 15-week intervention period.

  2. 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 (Bernina, AlpineAI) against a 64-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), not covered (0), or not applicable (conditional items without a documented trigger); the score is the proportion of applicable items covered, and report length in characters is used to compute information density.

    Time frame: 24 Weeks

  3. 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. A deterioration margin of -4 points is prespecified as an interpretive benchmark, interpreted as for the WAI-SR.

    Time frame: 5 weeks pre intervention and 5 weeks during the intervention.

  4. 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 psychiatric adaptation of the Provider Documentation Summarization Quality Instrument (PDSQI-9) that uses the consultation as the reference standard, 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.

    Time frame: 15 Weeks

  5. 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.

    Time frame: 5 weeks in the pre-intervention period and the last Week (Week 15) of the post-intervention period.

07

Study locations

8 sites
  • Psychiatrie St. Gallen
    Heerbrugg, Canton of St. Gallen 9435, Switzerland
  • Psychiatrie St. Gallen
    Pfäfers Dorf, Canton of St. Gallen 7312, Switzerland
  • Psychiatrie St. Gallen
    Rorschach, Canton of St. Gallen 9400, Switzerland
  • Psychiatrie St. Gallen
    Sankt Gallen, Canton of St. Gallen 9000, Switzerland
  • Psychiatrie St. Gallen
    Sargans, Canton of St. Gallen 7320, Switzerland
  • Psychiatrie St. Gallen
    Uznach, Canton of St. Gallen 8730, Switzerland
  • Psychiatrie St. Gallen
    Wattwil, Canton of St. Gallen 9630, Switzerland
  • Psychiatrie St. Gallen
    Wil, Canton of St. Gallen 9500, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Mar 2027, 8 months after the start.

Of 253 non-industry interventional studies with no phase under Burnout, Psychological, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 8 months is below that.

Counting every sponsor, half of 260 studies reached it within 12 months; a quarter within 5 and three quarters within 24.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 28, 2026: primary completion Dec 2026 → Mar 2027 and completion Dec 2026 → Mar 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2026
First posted
Aug 20, 2026
StartActual
Jul 13, 2026
Primary completionEst.
Mar 31, 2027was Dec 2026
CompletionEst.
Mar 31, 2027was Dec 2026
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Dec 31, 2026→Mar 31, 2027
Oct 28, 2026
Study completion
Dec 31, 2026→Mar 31, 2027
Oct 28, 2026
Eligibility
1 criterion edited
What changed in the criteria
  • EditedPatients 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.
Oct 28, 2026
Primary outcomes
2 time frame changed, 2 description edited
What changed in the outcomes
  • Time frameTime spent on psychiatric documentation24 Weeks → Pre-intervention period (13 weeks; 25 weeks for late-starting providers) and 15-week intervention period.
  • Time frameDocumentation quality of initial psychiatric asessment reports24 Weeks → Pre-intervention period (13 weeks; 25 weeks for late-starting providers) and 15-week intervention period.
  • DescriptionTime spent on psychiatric documentation: how it is measured was reworded
  • DescriptionWorking Alliance: how it is measured was reworded
Oct 28, 2026
Secondary outcomes
1 time frame changed, 3 description edited
What changed in the outcomes
  • Time frameTime passed from initial psychiatric assessment note creation to its completion24 Weeks → Pre-intervention period (13 weeks; 25 weeks for late-starting providers) and 15-week intervention period.
  • DescriptionDocumentation quality of ambient scribe-generated initial psychiatric assessment reports (raw AI output): how it is measured was reworded
  • DescriptionGuideline-relevant information coverage and density in initial psychiatric assessment reports: how it is measured was reworded
  • DescriptionPatient-perceived empathy of mental health care providers during consultations: how it is measured was reworded
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    Primary completion Dec 31, 2026→Mar 31, 2027
    Study completion Dec 31, 2026→Mar 31, 2027
    Eligibility 1 criterion edited
    What changed in the criteria
    • EditedPatients 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.
    Primary outcomes 2 time frame changed, 2 description edited
    What changed in the outcomes
    • Time frameTime spent on psychiatric documentation24 Weeks → Pre-intervention period (13 weeks; 25 weeks for late-starting providers) and 15-week intervention period.
    • Time frameDocumentation quality of initial psychiatric asessment reports24 Weeks → Pre-intervention period (13 weeks; 25 weeks for late-starting providers) and 15-week intervention period.
    • DescriptionTime spent on psychiatric documentation: how it is measured was reworded
    • DescriptionWorking Alliance: how it is measured was reworded
    Secondary outcomes 1 time frame changed, 3 description edited
    What changed in the outcomes
    • Time frameTime passed from initial psychiatric assessment note creation to its completion24 Weeks → Pre-intervention period (13 weeks; 25 weeks for late-starting providers) and 15-week intervention period.
    • DescriptionDocumentation quality of ambient scribe-generated initial psychiatric assessment reports (raw AI output): how it is measured was reworded
    • DescriptionGuideline-relevant information coverage and density in initial psychiatric assessment reports: how it is measured was reworded
    • DescriptionPatient-perceived empathy of mental health care providers during consultations: how it is measured was reworded
    + 4 other changes: verification date, description, design details and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07777224
Lead sponsor
Psychiatrie St. Gallen
Collaborators
University of St.Gallen
Responsible party
Maja Dobelsek, MD (Acting Consultant Psychiatrist & Head of the Wattwil Outpatient Clinic, Psychiatrie St. Gallen) — Principal investigator
First posted
Aug 20, 2026
Start date
Jul 13, 2026
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

Maja Dobelsek, MD
principal investigator · Universität St. Gallen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion