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

Not Applicable

• Conditions: Schizo Affective Disorder; Bipolar Disorder; Psychosis; Schizophrenia; Depressive Disorder
• Interventions: Behavioral: CBTpro

• Registration Number: NCT05127837
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-19
• Study Start: 2022-06-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-22
• Primary Completion: 2023-09-12
• Study Completion: 2024-02-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBTpro	CBTpro	In addition to TAU, clinicians and clients receive the CBTpro training.

Primary Outcome Measures

Name	Time	Method
Change in Positive and Negative Syndrome Scale (PANSS)	0,3,6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Recovery Assessment Scale (RAS)	0,3,6 months	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.
Change in WHO Disability Assessment Schedule 2.0 (WHODAS)	0,3,6 months	The WHODAS ranges from 0 to 48 points. A lower score means better functioning. As such, a lower score is a better outcome.

Trial Locations

Locations (6)

Sound Health; 🇺🇸 Seattle, Washington, United States

Lifeworks NW; 🇺🇸 Portland, Oregon, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Comprehensive Healthcare; 🇺🇸 Yakima, Washington, United States

Psynergy; 🇺🇸 Morgan Hill, California, United States

Frontier Behavioral Health; 🇺🇸 Spokane, Washington, United States