PsychosisCBTproNCT05127837
CBTpro: Scaling up CBT for Psychosis Using Simulated Patients and Spoken Language Technologies
A study testing CBTpro in people with Psychosis and Schizophrenia, run by University of Washington at 13 sites in United States.
Trial summary
The primary objective of this grant is to develop and evaluate an Artificial Intelligence-based clinical training tool--CBTpro--to support high-quality skills training in CBT for psychosis (CBTp). CBTpro will provide a rapid means of scaling and sustaining high-quality CBTp in routine care settings across the US. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Psychosis, Schizophrenia, Schizo Affective Disorder
- What is being tested?
- CBTpro
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 13 sitesUnited States
- Study dates
- 28 Jun 2022to 9 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Client Inclusion: Adults who speak English, meet with their provider who is participating in the study at least bi-weekly (2x a month), and do not plan to leave services in the next 6 months. Qualifying diagnoses for clients include: schizophrenia; schizoaffective disorder; schizophreniform disorder; delusional disorder; other specified schizophrenia spectrum and other psychotic disorder; unspecified schizophrenia spectrum or other psychotic disorder; bipolar disorder with psychotic features; major depressive disorder with psychotic features
Exclusion criteria: Dx of psychosis secondary to substance intoxication
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Coleman Health Services
Akron, Ohio, 44223
PeaceHealth
Eugene, Oregon, 97401
Integrated Services of Kalamazoo
Kalamazoo, Michigan, 49007
Community Mental Health Authority of Clinton, Eaton, and Ingham Counties (CEICMH)
Lansing, Michigan, 48823
South Central Health and Rehabilitation Programs
Los Angeles, California, 90003
Psynergy
Morgan Hill, California, 93927
Cascadia
Portland, Oregon, 97207
Lifeworks NW
Portland, Oregon, 97221
Telecare
San Jose, California, 95116
Harborview Medical Center
Seattle, Washington, 98104
Sound Health
Seattle, Washington, 98122
Frontier Behavioral Health
Spokane, Washington, 99208
Comprehensive Healthcare
Yakima, Washington, 98902
About this study
Official title: Development of an Artificial Intelligence- Informed Digital Tool to Help Clinicians Practice Cognitive Behavioral Therapy for Psychosis (CBTp)
The primary objective of this grant is to develop and evaluate an Artificial Intelligence-based clinical training tool--CBTpro--to support high-quality skills training in CBT for psychosis (CBTp). CBTpro will provide a rapid means of scaling and sustaining high-quality CBTp in routine care settings across the US.
Read the detailed description
This fast-track Small Business Technology Transfer (STTR) grant is a partnership between the University of Washington and private company LYSSN that includes the development and iterative testing of CBTpro, a Computerized Clinician Support Tool designed to teach behavioral health providers and students Cognitive Behavioral Therapy for psychosis (CBTp). CBTpro uses natural language processing to provide automated speech-to-text and machine learning to score trainee's responses to simulated patients with psychosis.
Once technical reliability of the tool is achieved through iterative modifications based on usability and field trials, a randomized control trial will be conducted to assess CBTpro training vs. training as usual with N=100 providers / N=300 clients on clinician skills and client outcomes.
- Conditions
- Psychosis, Schizophrenia, Schizo Affective Disorder, Bipolar Disorder, Depressive Disorder
- Being tested
- CBTpro
- Keywords
- Clinician Training, AI (artificial Intelligence), Machine learning, NLP (natural language processing), Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Bipolar Disorder, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTproBehavioural
CBTpro is a novel spoken language technology tool to support high-quality skills training in CBT for psychosis.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | No intervention | CBT for psychosis distance learning course. |
| CBTpro | Experimental | In addition to TAU, clinicians also receive the CBTpro training. Clients do not receive CBTpro training directly; rather, they receive routine clinical care from participating providers, and client outcomes are assessed to evaluate the effects of provider training. Receives: Behavioral: CBTpro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Green Paranoid Thoughts Scale (R-GPTS) Mean Score
The Revised Green Paranoid Thoughts Scale (R-GPTS) is a self-report measure of paranoid thinking over the past month, consisting of two validated subscales: Subscale A: Ideas of Reference (0-32) and Subscale B: Ideas of Persecution (0-40). Items are rated from 0 ("Not at all") to 4 ("Totally"), and each subscale is scored independently by summing item responses, with higher scores indicating greater severity. Scores ≥18 on the Persecution scale indicate clinically severe paranoid ideation. This measure was only collected and reported for client participants.
Measured: 0,3,6 months
Secondary outcomes (2)
Change in CHOICE-SF (Choice of Outcome in CBT for Psychosis- Short Form)
The CHOICE-SF is a 12-item self-report questionnaire designed to assess perceived progress toward recovery among individuals receiving cognitive behavioral therapy for psychosis (CBTp). Each item is rated on a scale from 0 ("Not at all") to 10 ("Extremely") with the exception of the final question which is open-entry. Total scores range from 0 to 110, with higher scores reflecting greater perceived progress in psychological recovery. An increase in the CHOICE-SF score indicates improvement in recovery; a decrease suggests reduced perceived progress.This measure was only collected and reported for client participants.
Measured: 0,3,6 months
Change in in Sheehan Disability Scale (SDS) Mean Score
The Sheehan Disability Scale (SDS) is a 3-item self-report measure that assesses functional impairment in three domains: work/school, social life, and family life/home responsibilities. Each item is rated on an 11-point scale from 0 ("Not at all impaired") to 10 ("Extremely impaired"). The total score ranges from 0 to 30, with higher scores indicating greater functional impairment. A decrease in the total score reflects improved functioning. This measure was only collected and reported for client participants.
Measured: 0,3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start28 Jun 2022
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Lyssn.io, Inc.
- Responsible party
- Principal investigator, Sarah Kopelovich, University of Washington
- Investigators
- Sarah Kopelovich, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127837
- Sponsor's protocol ID
- STUDY00014706
- Other IDs
- 5R42MH123215-02
- Acronym
- CBTpro
- Status last verified
- Feb 2026
- First submitted
- 9 Nov 2021
- Last updated
- 24 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research subject's de-identified data will be shared through the National Institute of Mental Health Data Archive (NDA).
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Artificial Intelligence- Informed Digital Tool to Help Clinicians Practice Cognitive Behavioral Therapy for Psychosis (CBTp)
- ClinicalTrials.gov ID
- NCT05127837
- Acronym / sponsor ID
- CBTpro / STUDY00014706
- Conditions
- Psychosis, Schizophrenia, Schizo Affective Disorder, Bipolar Disorder, Depressive Disorder
- Keywords
- Clinician Training, AI (artificial Intelligence), Machine learning, NLP (natural language processing), Cognitive Behavioral Therapy (CBT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Lyssn.io, Inc.
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this grant is to develop and evaluate an Artificial Intelligence-based clinical training tool--CBTpro--to support high-quality skills training in CBT for psychosis (CBTp). CBTpro will provide a rapid means of scaling and sustaining high-quality CBTp in routine care settings across the US.
Detailed description
This fast-track Small Business Technology Transfer (STTR) grant is a partnership between the University of Washington and private company LYSSN that includes the development and iterative testing of CBTpro, a Computerized Clinician Support Tool designed to teach behavioral health providers and students Cognitive Behavioral Therapy for psychosis (CBTp). CBTpro uses natural language processing to provide automated speech-to-text and machine learning to score trainee's responses to simulated patients with psychosis.
Once technical reliability of the tool is achieved through iterative modifications based on usability and field trials, a randomized control trial will be conducted to assess CBTpro training vs. training as usual with N=100 providers / N=300 clients on clinician skills and client outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | No intervention | –CBT for psychosis distance learning course. |
| CBTpro | Experimental | Behavioral: CBTproIn addition to TAU, clinicians also receive the CBTpro training. Clients do not receive CBTpro training directly; rather, they receive routine clinical care from participating providers, and client outcomes are assessed to evaluate the effects of provider training. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| CBTproCBTpro is a novel spoken language technology tool to support high-quality skills training in CBT for psychosis. | Behavioural | CBTpro |
Primary outcome
Revised Green Paranoid Thoughts Scale (R-GPTS) Mean Score
Time frame: 0,3,6 months
The Revised Green Paranoid Thoughts Scale (R-GPTS) is a self-report measure of paranoid thinking over the past month, consisting of two validated subscales: Subscale A: Ideas of Reference (0-32) and Subscale B: Ideas of Persecution (0-40). Items are rated from 0 ("Not at all") to 4 ("Totally"), and each subscale is scored independently by summing item responses, with higher scores indicating greater severity. Scores ≥18 on the Persecution scale indicate clinically severe paranoid ideation. This measure was only collected and reported for client participants.
2 secondary outcomes
Change in CHOICE-SF (Choice of Outcome in CBT for Psychosis- Short Form)
Time frame: 0,3,6 months
Change in in Sheehan Disability Scale (SDS) Mean Score
Time frame: 0,3,6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Research subject's de-identified data will be shared through the National Institute of Mental Health Data Archive (NDA).
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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.
Sarah Kopelovich, PhD principal investigator
University of Washington
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBTpro in people with Psychosis and Schizophrenia, run by University of Washington at 13 sites 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?
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 24 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 13 sites 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. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Revised Green Paranoid Thoughts Scale (R-GPTS) Mean Score (time frame: 0,3,6 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 24 Aug 2026.