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

Sponsor

University of Washington (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05127837

Collaborator

National Institute of Mental Health (NIMH) (NIH)

300

Enrollment

Locations

Arms

17.4

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psychosis Schizophrenia Schizo Affective Disorder Bipolar Disorder Depressive Disorder	Behavioral: CBTpro	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Development of an Artificial Intelligence- Informed Digital Tool to Help Clinicians Practice Cognitive Behavioral Therapy for Psychosis (CBTp)

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 12, 2023

Anticipated Study Completion Date :

Jan 12, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Treatment as Usual (TAU) CBT for psychosis distance learning course.
Experimental: CBTpro In addition to TAU, clinicians and clients receive the CBTpro training.	Behavioral: CBTpro CBTpro is a novel spoken language technology tool to support high-quality skills training in CBT for psychosis.

Arm

Intervention/Treatment

No Intervention: Treatment as Usual (TAU)

CBT for psychosis distance learning course.

Experimental: CBTpro

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

Behavioral: CBTpro

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

Outcome Measures

Primary Outcome Measures

Change in Positive and Negative Syndrome Scale (PANSS) [0,3,6 months]
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) [0,3,6 months]
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) [0,3,6 months]
The WHODAS ranges from 0 to 48 points. A lower score means better functioning. As such, a lower score is a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valley Cities Behavioral Health Care	Auburn	Washington	United States	98002
2	Comprehensive Healthcare	Ellensburg	Washington	United States	98926
3	Valley Cities Behavioral Health Care	Federal Way	Washington	United States	98003
4	Comprehensive Healthcare	Goldendale	Washington	United States	98620
5	Valley Cities Behavioral Health Care	Kent	Washington	United States	98032
6	Valley Cities Behavioral Health Care	Midway	Washington	United States	98198
7	Valley Cities Behavioral Health Care	Seattle	Washington	United States	98118
8	Comprehensive Healthcare	Sunnyside	Washington	United States	98944
9	Comprehensive Healthcare	Walla Walla	Washington	United States	99362
10	Comprehensive Healthcare	Yakima	Washington	United States	98902