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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
First received
Last updated
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
Health authority
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

Study Design


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
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