Generalized Anxiety Disorder (GAD)NCT07225192
Therapy and Tech Study
A study testing Chatbot Therapy in people with Generalized Anxiety Disorder (GAD) and Major Depressive Disorder, run by University of California, Irvine.
Trial summary
The investigators want to test if gen AI can support therapy by recruiting patients already in therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder (GAD), Major Depressive Disorder
- What is being tested?
- Chatbot Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Jan 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+
- US Resident
- English-speaking
- Self-report having been treated for or diagnosed with generalized anxiety disorder or major depressive disorder by a licensed provider (e.g., MD, DO, LPCC, LCSW, LMFT) in the past 12 months
- Self-report currently being in individual therapy
Who cannot join
- Ever diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or hospitalized for suicidality
About this study
The investigators want to test if gen AI can support therapy by recruiting patients already in therapy.
Read the detailed description
Recent advancements in AI have led to chatbots, such as ChatGPT, capable of providing therapeutic responses. Early research evaluating chatbots' ability to provide relationship advice and single-session relationship interventions has showed that both laypeople and relationship therapists rate them high on attributes such as empathy and helpfulness. The investigators want to test if chatbots can be a good adjunct to traditional therapy. The investigators hypothesize that participants who regularly use a chatbot as an adjunct to traditional therapy will have better mental health outcomes. Participants will complete baseline, 4-week (post-intervention) and 4-week post-intervention measures and will be invited to gain their therapists ratings.
- Being tested
- Chatbot Therapy
- Medical subject headings
- Generalized Anxiety Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot TherapyBehavioural
This group will be asked to use an AI chatbot like chatgpt as an adjunct to their regular therapy
| Study group | Role | What they receive |
|---|---|---|
| Chatbot Therapy Group | Experimental | Group 1 will be asked to use an AI chatbot like chatgpt as an adjunct to their regular therapy Receives: Behavioral: Chatbot Therapy |
| Control | No intervention | Group 2 will be asked to continue their regular therapy as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder (GAD-7)
Questions about symptoms of generalized anxiety disorder. Scale is 0-21. Higher scores is a worse outcome.
Measured: Baseline, 4-week follow-up, 8-week follow-up
Patient Health Questionnaire (PHQ-9)
Questions about symptoms of depression. Scale is 0-27. Higher score is a worse outcome.
Measured: Baseline, 4-week follow-up, 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Sean D Young, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225192
- Sponsor's protocol ID
- STUDY00000488
- Other IDs
- 4R33AT010606
- Status last verified
- Nov 2025
- First submitted
- 3 Nov 2025
- Last updated
- 21 Nov 2025
- 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy and Tech Study
- ClinicalTrials.gov ID
- NCT07225192
- Acronym / sponsor ID
- STUDY00000488
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 6 Nov 2025 (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 want to test if gen AI can support therapy by recruiting patients already in therapy.
Detailed description
Recent advancements in AI have led to chatbots, such as ChatGPT, capable of providing therapeutic responses. Early research evaluating chatbots' ability to provide relationship advice and single-session relationship interventions has showed that both laypeople and relationship therapists rate them high on attributes such as empathy and helpfulness. The investigators want to test if chatbots can be a good adjunct to traditional therapy. The investigators hypothesize that participants who regularly use a chatbot as an adjunct to traditional therapy will have better mental health outcomes. Participants will complete baseline, 4-week (post-intervention) and 4-week post-intervention measures and will be invited to gain their therapists ratings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot Therapy Group | Experimental | Behavioral: Chatbot TherapyGroup 1 will be asked to use an AI chatbot like chatgpt as an adjunct to their regular therapy |
| Control | No intervention | –Group 2 will be asked to continue their regular therapy as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18+
- US Resident
- English-speaking
- Self-report having been treated for or diagnosed with generalized anxiety disorder or major depressive disorder by a licensed provider (e.g., MD, DO, LPCC, LCSW, LMFT) in the past 12 months
- Self-report currently being in individual therapy
Key exclusion criteria (1 listed)
- Ever diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or hospitalized for suicidality
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 |
|---|---|---|
| Chatbot TherapyThis group will be asked to use an AI chatbot like chatgpt as an adjunct to their regular therapy | Behavioural | Chatbot Therapy Group |
Primary outcome
Generalized Anxiety Disorder (GAD-7)
Time frame: Baseline, 4-week follow-up, 8-week follow-up
Questions about symptoms of generalized anxiety disorder. Scale is 0-21. Higher scores is a worse outcome.
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 4-week follow-up, 8-week follow-up
Questions about symptoms of depression. Scale is 0-27. Higher score is a worse outcome.
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 21 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Generalized Anxiety Disorder (GAD)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 1
Microbiota Modulation for Psychiatry Patients
Depression - Major Depressive Disorder, Generalized Anxiety Disorder (GAD)
RecruitingPhase 3
A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Recruiting
Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
Generalized Anxiety Disorder
Not yet recruiting
Miles for Mental Health
Generalized Anxiety Disorder (GAD), Depressive and Anxiety Disorders
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot Therapy in people with Generalized Anxiety Disorder (GAD) and Major Depressive Disorder, run by University of California, Irvine.
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 5 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: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Generalized Anxiety Disorder (GAD-7) (time frame: Baseline, 4-week follow-up, 8-week follow-up). 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 21 Nov 2025.