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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: CBTpro


Participation Criteria
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Eligibility Criteria
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Provider Inclusion Criteria: Frontline clinical staff who provide direct clinical services to adult outpatients at designated study sites Providers must carry a caseload that includes adults with primary psychotic disorders and / or major mood disorders with psychotic features Provider Exclusion Criteria: Providers who participated in previous activities for this grant Providers who have been previously trained in CBTp Client Inclusion Criteria: Over 18 English-speaking and can read English at a 4th grade level or higher Chart diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar or depressive disorder with psychotic features, brief psychotic disorder, other specified psychotic disorder, unspecified schizophrenia spectrum and other psychotic disorder. Working with a provider who is enrolled in the study Can provide consent Client Exclusion Criteria: Psychosis secondary to substance intoxication, withdrawal or medical condition Unwilling to commit to weekly or biweekly clinic-based appointments Unwilling to consent to have clinic sessions recorded Plan to move or discontinue services at a participating clinic over the 6-month study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as Usual (TAU)<br>CBT for psychosis distance learning course. | |
| Experimental: CBTpro<br>In addition to TAU, clinicians and clients receive the CBTpro training. | Behavioral: CBTpro<br>* CBTpro is a novel spoken language technology tool to support high-quality skills training in CBT for psychosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Positive and Negative Syndrome Scale (PANSS) | The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For positive symptoms, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in symptoms. | 0,3,6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Recovery Assessment Scale (RAS) | The RAS is a 41-item self-report measure using a 5-point Likert scale with outcome scores ranging from 1-5 and increasing scores indicating better outcomes. | 0,3,6 months | 
| Change in WHO Disability Assessment Schedule 2.0 (WHODAS) | The WHODAS ranges from 0 to 48 points. A lower score means better functioning. As such, a lower score is a better outcome. | 0,3,6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinician Training, AI (artificial Intelligence), Machine learning, NLP (natural language processing), Cognitive Behavioral Therapy (CBT)