Trial Outcomes & Findings for CBTpro: Scaling up CBT for Psychosis Using Simulated Patients and Spoken Language Technologies (NCT NCT05127837)
NCT ID: NCT05127837
Last Updated: 2026-08-24
Results Overview
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.
COMPLETED
NA
601 participants
0,3,6 months
2026-08-24
Participant Flow
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.
Unit of analysis: Clinic Sites
Participant milestones
| Measure |
Treatment as Usual (TAU)
CBT for psychosis distance learning course.
|
CBTpro
In addition to TAU, clinicians receive the CBTpro training and apply what is learned to sessions with participating clients.
|
|---|---|---|
|
Overall Study
STARTED
|
285 31
|
316 33
|
|
Overall Study
Provider Participants
|
112 31
|
110 33
|
|
Overall Study
Client Participants
|
173 31
|
206 33
|
|
Overall Study
COMPLETED
|
165 31
|
201 33
|
|
Overall Study
NOT COMPLETED
|
120 0
|
115 0
|
Reasons for withdrawal
| Measure |
Treatment as Usual (TAU)
CBT for psychosis distance learning course.
|
CBTpro
In addition to TAU, clinicians receive the CBTpro training and apply what is learned to sessions with participating clients.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
27
|
24
|
|
Overall Study
Physician Decision
|
18
|
22
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Incarcerated
|
3
|
2
|
|
Overall Study
No longer at agency
|
17
|
20
|
|
Overall Study
Long term hospitalization
|
3
|
1
|
|
Overall Study
No longer meets eligibility criteria
|
18
|
16
|
|
Overall Study
Lost to Follow-up
|
33
|
30
|
Baseline Characteristics
CBTpro: Scaling up CBT for Psychosis Using Simulated Patients and Spoken Language Technologies
Baseline characteristics by cohort
| Measure |
Client Treatment as Usual (TAU)
n=136 Participants
CBT for psychosis distance learning course.
|
Client CBTpro
n=164 Participants
In addition to TAU, clinicians and clients receive the CBTpro training.
|
Provider Treatment as Usual (TAU)
n=51 Participants
CBT for psychosis distance learning course.
|
Provider CBTpro
n=51 Participants
In addition to TAU, clinicians and clients receive the CBTpro training.
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.27 years
STANDARD_DEVIATION 12.86 • n=1541 Participants
|
44.95 years
STANDARD_DEVIATION 14.53 • n=1121 Participants
|
38.1 years
STANDARD_DEVIATION 13.09 • n=2662 Participants
|
36.43 years
STANDARD_DEVIATION 11.33 • n=113 Participants
|
42.83 years
STANDARD_DEVIATION 13.97 • n=793 Participants
|
|
Sex/Gender, Customized
Gender Identity · Female
|
57 Participants
n=1541 Participants
|
78 Participants
n=1121 Participants
|
31 Participants
n=2662 Participants
|
41 Participants
n=113 Participants
|
207 Participants
n=793 Participants
|
|
Sex/Gender, Customized
Gender Identity · Male
|
70 Participants
n=1541 Participants
|
79 Participants
n=1121 Participants
|
16 Participants
n=2662 Participants
|
8 Participants
n=113 Participants
|
173 Participants
n=793 Participants
|
|
Sex/Gender, Customized
Gender Identity · Non-binary or non-gender conforming
|
2 Participants
n=1541 Participants
|
3 Participants
n=1121 Participants
|
4 Participants
n=2662 Participants
|
2 Participants
n=113 Participants
|
11 Participants
n=793 Participants
|
|
Sex/Gender, Customized
Gender Identity · Transgender FTM
|
2 Participants
n=1541 Participants
|
2 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
0 Participants
n=113 Participants
|
4 Participants
n=793 Participants
|
|
Sex/Gender, Customized
Gender Identity · Transgender MTF
|
4 Participants
n=1541 Participants
|
1 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
0 Participants
n=113 Participants
|
5 Participants
n=793 Participants
|
|
Sex/Gender, Customized
Gender Identity · Other
|
1 Participants
n=1541 Participants
|
1 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
0 Participants
n=113 Participants
|
2 Participants
n=793 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=1541 Participants
|
21 Participants
n=1121 Participants
|
13 Participants
n=2662 Participants
|
10 Participants
n=113 Participants
|
69 Participants
n=793 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
111 Participants
n=1541 Participants
|
143 Participants
n=1121 Participants
|
38 Participants
n=2662 Participants
|
41 Participants
n=113 Participants
|
333 Participants
n=793 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=793 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=1541 Participants
|
1 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
1 Participants
n=113 Participants
|
7 Participants
n=793 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=1541 Participants
|
8 Participants
n=1121 Participants
|
1 Participants
n=2662 Participants
|
3 Participants
n=113 Participants
|
16 Participants
n=793 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1541 Participants
|
1 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
0 Participants
n=113 Participants
|
1 Participants
n=793 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=1541 Participants
|
17 Participants
n=1121 Participants
|
11 Participants
n=2662 Participants
|
3 Participants
n=113 Participants
|
62 Participants
n=793 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=1541 Participants
|
121 Participants
n=1121 Participants
|
27 Participants
n=2662 Participants
|
39 Participants
n=113 Participants
|
269 Participants
n=793 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=1541 Participants
|
16 Participants
n=1121 Participants
|
12 Participants
n=2662 Participants
|
3 Participants
n=113 Participants
|
45 Participants
n=793 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
2 Participants
n=113 Participants
|
2 Participants
n=793 Participants
|
PRIMARY outcome
Timeframe: 0,3,6 monthsPopulation: The population number analyzed varies across time points because some participants were lost to follow-up at the 3- and 6-month assessments.
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.
Outcome measures
| Measure |
Treatment as Usual (TAU)
n=136 Participants
CBT for psychosis distance learning course.
|
CBTpro
n=164 Participants
In addition to TAU, clinicians and clients receive the CBTpro training.
|
|---|---|---|
|
Revised Green Paranoid Thoughts Scale (R-GPTS) Mean Score
Baseline - Subscale A
|
12.1 Score on a Scale
Standard Deviation 8.7
|
12.3 Score on a Scale
Standard Deviation 8.8
|
|
Revised Green Paranoid Thoughts Scale (R-GPTS) Mean Score
3 Months - Subscale A
|
12.1 Score on a Scale
Standard Deviation 8.9
|
11.4 Score on a Scale
Standard Deviation 8.1
|
|
Revised Green Paranoid Thoughts Scale (R-GPTS) Mean Score
6 Months - Subscale A
|
11.1 Score on a Scale
Standard Deviation 8.4
|
11 Score on a Scale
Standard Deviation 8.3
|
|
Revised Green Paranoid Thoughts Scale (R-GPTS) Mean Score
Baseline - Subscale B
|
12.7 Score on a Scale
Standard Deviation 11.1
|
14.1 Score on a Scale
Standard Deviation 12.6
|
|
Revised Green Paranoid Thoughts Scale (R-GPTS) Mean Score
3 Months - Subscale B
|
13.3 Score on a Scale
Standard Deviation 12.3
|
10.7 Score on a Scale
Standard Deviation 10.7
|
|
Revised Green Paranoid Thoughts Scale (R-GPTS) Mean Score
6 Months - Subscale B
|
11.9 Score on a Scale
Standard Deviation 12.2
|
11.4 Score on a Scale
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 0,3,6 monthsPopulation: The population number analyzed varies across time points because some participants were lost to follow-up at the 3- and 6-month assessments.
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.
Outcome measures
| Measure |
Treatment as Usual (TAU)
n=136 Participants
CBT for psychosis distance learning course.
|
CBTpro
n=164 Participants
In addition to TAU, clinicians and clients receive the CBTpro training.
|
|---|---|---|
|
Change in CHOICE-SF (Choice of Outcome in CBT for Psychosis- Short Form)
Baseline
|
6.2 Score on a Scale
Standard Deviation 2.0
|
6.1 Score on a Scale
Standard Deviation 1.8
|
|
Change in CHOICE-SF (Choice of Outcome in CBT for Psychosis- Short Form)
3 Months
|
6.1 Score on a Scale
Standard Deviation 1.8
|
6.4 Score on a Scale
Standard Deviation 1.8
|
|
Change in CHOICE-SF (Choice of Outcome in CBT for Psychosis- Short Form)
6 Months
|
6.1 Score on a Scale
Standard Deviation 1.9
|
6.6 Score on a Scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 0,3,6 monthsPopulation: The population number analyzed varies across time points because some participants were lost to follow-up at the 3- and 6-month assessments.
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.
Outcome measures
| Measure |
Treatment as Usual (TAU)
n=136 Participants
CBT for psychosis distance learning course.
|
CBTpro
n=163 Participants
In addition to TAU, clinicians and clients receive the CBTpro training.
|
|---|---|---|
|
Change in in Sheehan Disability Scale (SDS) Mean Score
6 Months
|
14.4 Score on a Scale
Standard Deviation 10.2
|
13.1 Score on a Scale
Standard Deviation 9.6
|
|
Change in in Sheehan Disability Scale (SDS) Mean Score
Baseline
|
14.5 Score on a Scale
Standard Deviation 8.8
|
14.2 Score on a Scale
Standard Deviation 9.4
|
|
Change in in Sheehan Disability Scale (SDS) Mean Score
3 Months
|
14.0 Score on a Scale
Standard Deviation 9.6
|
13.9 Score on a Scale
Standard Deviation 9.4
|
Adverse Events
Provider Treatment as Usual (TAU)
Provider CBTpro
Client CBTpro
Client Treatment as Usual (TAU)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place