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| ID | Type | Description | Link |
|---|---|---|---|
| 5R42MH123215-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Lyssn.io, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBTpro | Behavioral | CBTpro is a novel spoken language technology tool to support high-quality skills training in CBT for psychosis. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CHOICE-SF (Choice of Outcome in CBT for Psychosis- Short Form) | The CHOICE-SF is a 12-item self-report questionnaire designed to assess perceived progress toward recovery among individuals receiving cognitive behavioral therapy for psychosis (CBTp). Each item is rated on a scale from 0 ("Not at all") to 10 ("Extremely") with the exception of the final question which is open-entry. Total scores range from 0 to 110, with higher scores reflecting greater perceived progress in psychological recovery. An increase in the CHOICE-SF score indicates improvement in recovery; a decrease suggests reduced perceived progress.This measure was only collected and reported for client participants. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Kopelovich, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Central Health and Rehabilitation Programs | Los Angeles | California | 90003 | United States | ||
| Psynergy |
Research subject's de-identified data will be shared through the National Institute of Mental Health Data Archive (NDA).
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Community mental health clinics were recruited and randomized to one of two training conditions (CBTpro vs. TAU). Eligible providers at each site participated along with three clients during the training period. Client data, including clinical outcomes associated with provider training, are reported on.
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment as Usual (TAU) | CBT for psychosis distance learning course. |
| FG001 | CBTpro | In addition to TAU, clinicians receive the CBTpro training and apply what is learned to sessions with participating clients. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2025 |
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| 0,3,6 months |
| Change in in Sheehan Disability Scale (SDS) Mean Score | The Sheehan Disability Scale (SDS) is a 3-item self-report measure that assesses functional impairment in three domains: work/school, social life, and family life/home responsibilities. Each item is rated on an 11-point scale from 0 ("Not at all impaired") to 10 ("Extremely impaired"). The total score ranges from 0 to 30, with higher scores indicating greater functional impairment. A decrease in the total score reflects improved functioning. This measure was only collected and reported for client participants. | 0,3,6 months |
| Morgan Hill |
| California |
| 93927 |
| United States |
| Telecare | San Jose | California | 95116 | United States |
| Integrated Services of Kalamazoo | Kalamazoo | Michigan | 49007 | United States |
| Community Mental Health Authority of Clinton, Eaton, and Ingham Counties (CEICMH) | Lansing | Michigan | 48823 | United States |
| Coleman Health Services | Akron | Ohio | 44223 | United States |
| PeaceHealth | Eugene | Oregon | 97401 | United States |
| Cascadia | Portland | Oregon | 97207 | United States |
| Lifeworks NW | Portland | Oregon | 97221 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Sound Health | Seattle | Washington | 98122 | United States |
| Frontier Behavioral Health | Spokane | Washington | 99208 | United States |
| Comprehensive Healthcare | Yakima | Washington | 98902 | United States |
| Provider Participants |
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| Client Participants |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Client Treatment as Usual (TAU) | CBT for psychosis distance learning course. |
| BG001 | Client CBTpro | In addition to TAU, clinicians and clients receive the CBTpro training. |
| BG002 | Provider Treatment as Usual (TAU) | CBT for psychosis distance learning course. |
| BG003 | Provider CBTpro | In addition to TAU, clinicians and clients receive the CBTpro training. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex/Gender, Customized | Baseline Gender Identity | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Ethnicity | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Race | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The population number analyzed varies across time points because some participants were lost to follow-up at the 3- and 6-month assessments. | Posted | Mean | Standard Deviation | Score on a Scale | 0,3,6 months |
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| Secondary | Change in CHOICE-SF (Choice of Outcome in CBT for Psychosis- Short Form) | The CHOICE-SF is a 12-item self-report questionnaire designed to assess perceived progress toward recovery among individuals receiving cognitive behavioral therapy for psychosis (CBTp). Each item is rated on a scale from 0 ("Not at all") to 10 ("Extremely") with the exception of the final question which is open-entry. Total scores range from 0 to 110, with higher scores reflecting greater perceived progress in psychological recovery. An increase in the CHOICE-SF score indicates improvement in recovery; a decrease suggests reduced perceived progress.This measure was only collected and reported for client participants. | The population number analyzed varies across time points because some participants were lost to follow-up at the 3- and 6-month assessments. | Posted | Mean | Standard Deviation | Score on a Scale | 0,3,6 months |
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| Secondary | Change in in Sheehan Disability Scale (SDS) Mean Score | The Sheehan Disability Scale (SDS) is a 3-item self-report measure that assesses functional impairment in three domains: work/school, social life, and family life/home responsibilities. Each item is rated on an 11-point scale from 0 ("Not at all impaired") to 10 ("Extremely impaired"). The total score ranges from 0 to 30, with higher scores indicating greater functional impairment. A decrease in the total score reflects improved functioning. This measure was only collected and reported for client participants. | The population number analyzed varies across time points because some participants were lost to follow-up at the 3- and 6-month assessments. | Posted | Mean | Standard Deviation | Score on a Scale | 0,3,6 months |
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Data was collected for each participant at baseline, 3 months post-intervention. 6 months follow-up were collected for clients only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Client Treatment as Usual (TAU) | CBT for psychosis distance learning course. | 1 | 173 | 0 | 173 | 0 | 173 |
| EG001 | Client CBTpro | In addition to TAU, clinicians and clients receive the CBTpro training. | 0 | 206 | 0 | 206 | 0 | 206 |
| EG002 | Provider Treatment as Usual (TAU) | CBT for psychosis distance learning course. | 0 | 112 | 0 | 112 | 0 | 112 |
| EG003 | Provider CBTpro | In addition to TAU, clinicians and clients receive the CBTpro training. | 0 | 110 | 0 | 110 | 0 | 110 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Kopelovich, PhD | University of Washington | 206-543-3750 | skopelov@uw.edu |
| Nov 21, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| Male |
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| Non-binary or non-gender conforming |
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| Transgender FTM |
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| Transgender MTF |
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| Other |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 3 Months - Subscale A |
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| 6 Months - Subscale A |
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| Baseline - Subscale B |
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| 3 Months - Subscale B |
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| 6 Months - Subscale B |
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