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

NCT05127837 | Completed Results DMC

• 2 other identifiers: STUDY000147065R42MH123215-02
• Study Type: interventional
• Target: 601
• Locations: 1 country
• Sites: 13

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.

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)

Outcome Measures

Primary Outcomes (1)

• Revised Green Paranoid Thoughts Scale (R-GPTS) Mean Score

  The Revised Green Paranoid Thoughts Scale (R-GPTS) is a self-report measure of paranoid thinking over the past month, consisting of two validated subscales: Subscale A: Ideas of Reference (0-32) and Subscale B: Ideas of Persecution (0-40). Items are rated from 0 ("Not at all") to 4 ("Totally"), and each subscale is scored independently by summing item responses, with higher scores indicating greater severity. Scores ≥18 on the Persecution scale indicate clinically severe paranoid ideation. This measure was only collected and reported for client participants.

  0,3,6 months

Secondary Outcomes (2)

• Change in CHOICE-SF (Choice of Outcome in CBT for Psychosis- Short Form)

  0,3,6 months

• Change in in Sheehan Disability Scale (SDS) Mean Score

  0,3,6 months

Study Arms (2)

Treatment as Usual (TAU)

NO INTERVENTION

CBT for psychosis distance learning course.

CBTpro

EXPERIMENTAL

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

Behavioral: CBTpro

Interventions

CBTpro BEHAVIORAL

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

CBTpro

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator
• Lyssn.io, Inc.: collaborator

Study Sites (13)

South Central Health and Rehabilitation Programs

Los Angeles, California, 90003, United States

Location

Psynergy

Morgan Hill, California, 93927, United States

Location

Telecare

San Jose, California, 95116, United States

Location

Integrated Services of Kalamazoo

Kalamazoo, Michigan, 49007, United States

Location

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

Lansing, Michigan, 48823, United States

Location

Coleman Health Services

Akron, Ohio, 44223, United States

Location

PeaceHealth

Eugene, Oregon, 97401, United States

Location

Cascadia

Portland, Oregon, 97207, United States

Location

Lifeworks NW

Portland, Oregon, 97221, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Sound Health

Seattle, Washington, 98122, United States

Location

Frontier Behavioral Health

Spokane, Washington, 99208, United States

Location

Comprehensive Healthcare

Yakima, Washington, 98902, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Bipolar Disorder; Depressive Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Results Point of Contact

• Title: Sarah Kopelovich, PhD
• Organization: University of Washington

skopelov@uw.edu

206-543-3750

Study Officials

• Sarah Kopelovich, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 19, 2021
• Study Start: June 28, 2022
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (13)