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

Primary Purpose

Psychosis, Schizophrenia, Schizo Affective Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBTpro
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Clinician Training, AI (artificial Intelligence), Machine learning, NLP (natural language processing), Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psynergy
  • Lifeworks NW
  • Harborview Medical Center
  • Sound Health
  • Frontier Behavioral Health
  • Comprehensive Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as Usual (TAU)

CBTpro

Arm Description

CBT for psychosis distance learning course.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 9, 2021
Last Updated
March 20, 2023
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH), Lyssn.io, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05127837
Brief Title
CBTpro: Scaling up CBT for Psychosis Using Simulated Patients and Spoken Language Technologies
Acronym
CBTpro
Official Title
Development of an Artificial Intelligence- Informed Digital Tool to Help Clinicians Practice Cognitive Behavioral Therapy for Psychosis (CBTp)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
September 12, 2023 (Anticipated)
Study Completion Date
February 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH), Lyssn.io, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
CBT for psychosis distance learning course.
Arm Title
CBTpro
Arm Type
Experimental
Arm Description
In addition to TAU, clinicians and clients receive the CBTpro training.
Intervention Type
Behavioral
Intervention Name(s)
CBTpro
Intervention Description
CBTpro is a novel spoken language technology tool to support high-quality skills training in CBT for psychosis.
Primary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS)
Description
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.
Time Frame
0,3,6 months
Secondary Outcome Measure Information:
Title
Change in Recovery Assessment Scale (RAS)
Description
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.
Time Frame
0,3,6 months
Title
Change in WHO Disability Assessment Schedule 2.0 (WHODAS)
Description
The WHODAS ranges from 0 to 48 points. A lower score means better functioning. As such, a lower score is a better outcome.
Time Frame
0,3,6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Kopelovich, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psynergy
City
Morgan Hill
State/Province
California
ZIP/Postal Code
93927
Country
United States
Facility Name
Lifeworks NW
City
Portland
State/Province
Oregon
ZIP/Postal Code
97221
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Sound Health
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Frontier Behavioral Health
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Comprehensive Healthcare
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Research subject's de-identified data will be shared through the National Institute of Mental Health Data Archive (NDA).

Learn more about this trial

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

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