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

Schizophrenia Clinical Trial

— CBTpro  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05127837
• Other study ID #: STUDY00014706
• Secondary ID: 5R42MH123215-02
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: February 12, 2024

Study information

• Verified date: March 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: February 12, 2024
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder
• Disease
• Mental Disorders
• Mood Disorders
• Psychosis
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
United States	Psynergy	Morgan Hill	California
United States	Lifeworks NW	Portland	Oregon
United States	Harborview Medical Center	Seattle	Washington
United States	Sound Health	Seattle	Washington
United States	Frontier Behavioral Health	Spokane	Washington
United States	Comprehensive Healthcare	Yakima	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Lyssn.io, Inc., National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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