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

NCT ID: NCT05127837

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-28

Study Completion Date

2024-12-09

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.

Conditions

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Psychosis Schizophrenia Schizo Affective Disorder Bipolar Disorder Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment as Usual (TAU)

CBT for psychosis distance learning course.

Group Type NO_INTERVENTION

No interventions assigned to this group

CBTpro

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

Group Type EXPERIMENTAL

CBTpro

Intervention Type BEHAVIORAL

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

Interventions

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CBTpro

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Lyssn.io, Inc.

INDUSTRY

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Sarah Kopelovich

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Kopelovich, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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South Central Health and Rehabilitation Programs

Los Angeles, California, United States

Site Status

Psynergy

Morgan Hill, California, United States

Site Status

Telecare

San Jose, California, United States

Site Status

Integrated Services of Kalamazoo

Kalamazoo, Michigan, United States

Site Status

Community Mental Health Authority of Clinton, Eaton, and Ingham Counties (CEICMH)

Lansing, Michigan, United States

Site Status

Coleman Health Services

Akron, Ohio, United States

Site Status

PeaceHealth

Eugene, Oregon, United States

Site Status

Cascadia

Portland, Oregon, United States

Site Status

Lifeworks NW

Portland, Oregon, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Sound Health

Seattle, Washington, United States

Site Status

Frontier Behavioral Health

Spokane, Washington, United States

Site Status

Comprehensive Healthcare

Yakima, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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5R42MH123215-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00014706

Identifier Type: -

Identifier Source: org_study_id

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