Clinical trial NCT05127837: CBTpro: Scaling up CBT for Psychosis Using Simulated Patients and Spoken Language Technologies
Official title: Development of an Artificial Intelligence- Informed Digital Tool to Help Clinicians Practice Cognitive Behavioral Therapy for Psychosis (CBTp)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Schizophrenia
Schizo Affective Disorder
Bipolar Disorder
Depressive Disorder
Keywords: Clinician Training
AI (artificial Intelligence)
Machine learning
NLP (natural language processing)
Cognitive Behavioral Therapy (CBT)
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Lyssn.io, Inc.
First posted: 2021-11-19
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Green Paranoid Thoughts Scale (GPTS) Total Score
timeFrame: 0,3,6 months
Secondary outcomes:
measure: Change in CHOICE-SF (Choice of Outcome in CBT for Psychosis- Short Form)
timeFrame: 0,3,6 months
measure: Change in in Sheehan Disability Scale (SDS) Total Score
timeFrame: 0,3,6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: South Central Health and Rehabilitation Programs
state: California
city: Morgan Hill
country: United States
facility: Psynergy
state: California
city: San Jose
country: United States
facility: Telecare
state: California
city: Kalamazoo
country: United States
facility: Integrated Services of Kalamazoo
state: Michigan
city: Lansing
country: United States
facility: Community Mental Health Authority of Clinton, Eaton, and Ingham Counties (CEICMH)
state: Michigan
city: Akron
country: United States
facility: Coleman Health Services
state: Ohio
city: Eugene
country: United States
facility: PeaceHealth
state: Oregon
city: Portland
country: United States
facility: Cascadia
state: Oregon
city: Portland
country: United States
facility: Lifeworks NW
state: Oregon
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Sound Health
state: Washington
city: Spokane
country: United States
facility: Frontier Behavioral Health
state: Washington
city: Yakima
country: United States
facility: Comprehensive Healthcare
state: Washington
Study officials:
affiliation: University of Washington
name: Sarah Kopelovich, PhD
role: PRINCIPAL_INVESTIGATOR
References: