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CBTpro: Scaling up CBT for Psychosis Using Simulated Patients and Spoken Language Technologies

Development of an Artificial Intelligence- Informed Digital Tool to Help Clinicians Practice Cognitive Behavioral Therapy for Psychosis (CBTp)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05127837
Acronym
CBTpro
Enrollment
601
Registered
2021-11-19
Start date
2022-06-28
Completion date
2024-12-09
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Depressive Disorder, Psychosis, Schizo Affective Disorder, Schizophrenia

Keywords

Clinician Training, AI (artificial Intelligence), Machine learning, NLP (natural language processing), Cognitive Behavioral Therapy (CBT)

Brief 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.

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.

Interventions

BEHAVIORALCBTpro

CBTpro is a novel spoken language technology tool to support high-quality skills training in CBT for psychosis.

Sponsors

University of Washington
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Lyssn.io, Inc.
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Revised Green Paranoid Thoughts Scale (R-GPTS) Mean Score0,3,6 monthsThe 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.

Secondary

MeasureTime frameDescription
Change in CHOICE-SF (Choice of Outcome in CBT for Psychosis- Short Form)0,3,6 monthsThe 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.
Change in in Sheehan Disability Scale (SDS) Mean Score0,3,6 monthsThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSarah Kopelovich, PhD

University of Washington

Participant flow

Recruitment details

Community mental health clinics were recruited and randomized to one of two training conditions (CBTpro vs. TAU). Eligible providers at each site participated along with three clients during the training period. Client data, including clinical outcomes associated with provider training, are reported on.

Baseline characteristics

Characteristic
Age, Continuous42.83 years
STANDARD_DEVIATION 13.97
Ethnicity (NIH/OMB)
Hispanic or Latino
21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
143 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
8 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
45 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
White
121 Participants
Sex/Gender, Customized
Gender Identity
Female
41 Participants
Sex/Gender, Customized
Gender Identity
Male
16 Participants
Sex/Gender, Customized
Gender Identity
Non-binary or non-gender conforming
3 Participants
Sex/Gender, Customized
Gender Identity
Other
1 Participants
Sex/Gender, Customized
Gender Identity
Transgender FTM
0 Participants
Sex/Gender, Customized
Gender Identity
Transgender MTF
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
1 / 1730 / 2060 / 1120 / 110
other
Total, other adverse events
0 / 1730 / 2060 / 1120 / 110
serious
Total, serious adverse events
0 / 1730 / 2060 / 1120 / 110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026