Severe Mental IllnessNUKI-PSYNCT07658547
Use of AI Chatbots for Mental Health
An observational study of Severe Mental Illness, run by Medizinische Hochschule Brandenburg Theodor Fontane at 1 site in Germany.
Trial summary
The goal of this observational study is to learn how patients with mental disorders use, perceive, and evaluate generative artificial intelligence (AI) chatbots for mental health-related purposes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Mental Illness
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jul 2026to Nov 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Psychiatric outpatient clinics, medical practices, and counseling centers in Berlin/Brandenburg
Who may be able to join
- diagnosed mental illness
Who cannot join
- incapable of giving consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Use of AI Chatbots for Mental Health - an Online Survey of Patients With Severe Mental Illness
The goal of this observational study is to learn how patients with mental disorders use, perceive, and evaluate generative artificial intelligence (AI) chatbots for mental health-related purposes. The study aims to investigate usage patterns, expectations, experiences, perceived benefits, barriers, and concerns regarding AI chatbots among adults receiving psychiatric or psychotherapeutic treatment.
The main questions it aims to answer are:
Read more
- "How do patients with mental disorders use generative AI chatbots in the context of their mental health?"
- "What expectations, attitudes, and experiences do patients have regarding AI chatbots for mental health support?"
Participants will:
- Provide electronic informed consent before participation.
- Complete a one-time anonymous online survey lasting approximately 8 to 10 minutes.
- Answer questions about sociodemographic characteristics, psychiatric diagnoses, psychological distress, and digital device use.
- Report their expectations regarding AI chatbots for mental health support.
- Provide information about AI chatbot use, including frequency, duration, applications used, and purposes of use.
- Answer questions regarding satisfaction, trust, privacy concerns, perceived problems, and potential future integration of AI chatbots into mental health care.
- Optionally provide qualitative comments and suggestions in open-text fields.
- Optionally participate in semi-structured qualitative interviews to explore their experiences, attitudes, and perceptions regarding AI chatbots in greater depth.
There is no intervention, randomization, control group, or comparison arm in this study. The study follows a prospective cross-sectional mixed-methods design using quantitative survey data, qualitative free-text responses, and semi-structured interviews.
- Conditions
- Severe Mental Illness
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe Mental Illness | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who have used generative AI for mental health issues
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start31 Jul 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental IllnessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor Fontane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Schwarz, Medizinische Hochschule Brandenburg Theodor Fontane
- Investigators
- Schwarz, Principal investigator, Medizinische Hochschule Brandenburg Theodor Fontane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658547
- Sponsor's protocol ID
- 401022026-BO-E
- Acronym
- NUKI-PSY
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of AI Chatbots for Mental Health - an Online Survey of Patients With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT07658547
- Acronym / sponsor ID
- NUKI-PSY / 401022026-BO-E
- Conditions
- Severe Mental Illness
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor FontaneUniversity, hospital or other
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Jun 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 observational study is to learn how patients with mental disorders use, perceive, and evaluate generative artificial intelligence (AI) chatbots for mental health-related purposes. The study aims to investigate usage patterns, expectations, experiences, perceived benefits, barriers, and concerns regarding AI chatbots among adults receiving psychiatric or psychotherapeutic treatment.
The main questions it aims to answer are:
- "How do patients with mental disorders use generative AI chatbots in the context of their mental health?"
- "What expectations, attitudes, and experiences do patients have regarding AI chatbots for mental health support?"
Participants will:
- Provide electronic informed consent before participation.
- Complete a one-time anonymous online survey lasting approximately 8 to 10 minutes.
- Answer questions about sociodemographic characteristics, psychiatric diagnoses, psychological distress, and digital device use.
- Report their expectations regarding AI chatbots for mental health support.
- Provide information about AI chatbot use, including frequency, duration, applications used, and purposes of use.
- Answer questions regarding satisfaction, trust, privacy concerns, perceived problems, and potential future integration of AI chatbots into mental health care.
- Optionally provide qualitative comments and suggestions in open-text fields.
- Optionally participate in semi-structured qualitative interviews to explore their experiences, attitudes, and perceptions regarding AI chatbots in greater depth.
There is no intervention, randomization, control group, or comparison arm in this study. The study follows a prospective cross-sectional mixed-methods design using quantitative survey data, qualitative free-text responses, and semi-structured interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Mental Illness | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Psychiatric outpatient clinics, medical practices, and counseling centers in Berlin/Brandenburg
Key inclusion criteria (1 listed)
- diagnosed mental illness
Key exclusion criteria (1 listed)
- incapable of giving consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients who have used generative AI for mental health issues
Time frame: up to 6 months
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 8 Oct 2026.
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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.
Schwarz principal investigator
Medizinische Hochschule Brandenburg Theodor Fontane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Mental Illness, run by Medizinische Hochschule Brandenburg Theodor Fontane at 1 site in Germany.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 8 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 Germany. 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?
Percentage of patients who have used generative AI for mental health issues (time frame: up to 6 months). 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 8 Oct 2026.