Trial Outcomes & Findings for Improving Negative Symptoms of Psychosis In Real-world Environments (NCT NCT02170051)
NCT ID: NCT02170051
Last Updated: 2021-05-19
Results Overview
Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
baseline, 12.5 weeks
Results posted on
2021-05-19
Participant Flow
2 participants received the wrong diagnosis, and were withdrawn from the study; 7 participants had a CAINS score of ≤19, and were excluded from the study
Participant milestones
| Measure |
CBSST-CCT
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
CBSST-CCT
|
Goal-focused Supportive Contact
Goal-focused supportive contact
Goal focused supportive contact
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
29
|
|
Overall Study
Tested at Mid-point
|
13
|
18
|
|
Overall Study
Tested at Post-treatment
|
15
|
16
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
CBSST-CCT
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
CBSST-CCT
|
Goal-focused Supportive Contact
Goal-focused supportive contact
Goal focused supportive contact
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
10
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Improving Negative Symptoms of Psychosis In Real-world Environments
Baseline characteristics by cohort
| Measure |
CBSST-CCT
n=26 Participants
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
CBSST-CCT
|
Goal-focused Supportive Contact
n=29 Participants
Goal-focused supportive contact
Goal focused supportive contact
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
50.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
29 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 12.5 weeksChange in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity.
Outcome measures
| Measure |
CBSST-CCT
n=15 Participants
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
CBSST-CCT
|
Goal-focused Supportive Contact
n=17 Participants
Goal-focused supportive contact
Goal focused supportive contact
|
|---|---|---|
|
Clinical Assessment Interview for Negative Symptoms (CAINS)
|
.0667 score on a scale
Standard Deviation 4.02611
|
-.0588 score on a scale
Standard Deviation 5.85737
|
SECONDARY outcome
Timeframe: baseline, 12.5 weeksChange in cognitive performance in several domains at 12.5 weeks. Scores range from 0-80; higher scores indicate better performance.
Outcome measures
| Measure |
CBSST-CCT
n=15 Participants
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
CBSST-CCT
|
Goal-focused Supportive Contact
n=17 Participants
Goal-focused supportive contact
Goal focused supportive contact
|
|---|---|---|
|
MATRICS Consensus Cognitive Battery (MCCB)
|
.8778 score on a scale
Standard Deviation 3.40143
|
-.0065 score on a scale
Standard Deviation 2.87904
|
SECONDARY outcome
Timeframe: baseline, 12.5 weeksChange in communication and financial functioning at 12.5 weeks. Scores range from 0-100; higher scores indicate better performance.
Outcome measures
| Measure |
CBSST-CCT
n=15 Participants
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
CBSST-CCT
|
Goal-focused Supportive Contact
n=17 Participants
Goal-focused supportive contact
Goal focused supportive contact
|
|---|---|---|
|
UCSD Performance-based Skills Assessment-Brief (UPSA-B)
|
3.1667 score on a scale
Standard Deviation 13.91000
|
1.3882 score on a scale
Standard Deviation 10.42682
|
SECONDARY outcome
Timeframe: baseline, 12.5 weeksChange in social skills performance at 12.5 weeks. Scores range from 2-10; higher scores indicate better social skills.
Outcome measures
| Measure |
CBSST-CCT
n=15 Participants
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
CBSST-CCT
|
Goal-focused Supportive Contact
n=17 Participants
Goal-focused supportive contact
Goal focused supportive contact
|
|---|---|---|
|
Social Skills Performance Assessment (SSPA)
|
.1824 score on a scale
Standard Deviation .56812
|
.0548 score on a scale
Standard Deviation .43854
|
SECONDARY outcome
Timeframe: baseline, 12.5 weeksChange in self-reported functioning at 12.5 weeks. Scores range from 30-150. Higher score indicates better functioning.
Outcome measures
| Measure |
CBSST-CCT
n=15 Participants
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
CBSST-CCT
|
Goal-focused Supportive Contact
n=17 Participants
Goal-focused supportive contact
Goal focused supportive contact
|
|---|---|---|
|
Specific Levels of Functioning Scale (SLOF)
|
.1718 score on a scale
Standard Deviation .38527
|
.2498 score on a scale
Standard Deviation .63886
|
SECONDARY outcome
Timeframe: baseline, 12.5 weeksChange in self-reported functioning at 12.5 weeks. Scores range from 0-1; higher score indicates better skills.
Outcome measures
| Measure |
CBSST-CCT
n=15 Participants
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
CBSST-CCT
|
Goal-focused Supportive Contact
n=15 Participants
Goal-focused supportive contact
Goal focused supportive contact
|
|---|---|---|
|
Independent Living Skills Survey (ILSS)
|
.0121 score on a scale
Standard Deviation .04379
|
-.0078 score on a scale
Standard Deviation .06717
|
SECONDARY outcome
Timeframe: baseline, 12.5 weeksChange in defeatist attitudes at 12.5 weeks. Likert Scale 1-7; scores range from 15-105; higher scores indicate a more severe defeatist performance attitude.
Outcome measures
| Measure |
CBSST-CCT
n=15 Participants
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
CBSST-CCT
|
Goal-focused Supportive Contact
n=17 Participants
Goal-focused supportive contact
Goal focused supportive contact
|
|---|---|---|
|
Defeatist Performance Attitudes Scale (DPAS)
|
-3.8667 score on a scale
Standard Deviation 11.01860
|
1.1765 score on a scale
Standard Deviation 19.38825
|
SECONDARY outcome
Timeframe: baseline, 12.5 weeksChange in negative symptom severity at 12.5 weeks. Scores range from 0-25; higher values indicate greater severity.
Outcome measures
| Measure |
CBSST-CCT
n=15 Participants
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
CBSST-CCT
|
Goal-focused Supportive Contact
n=17 Participants
Goal-focused supportive contact
Goal focused supportive contact
|
|---|---|---|
|
Scale for the Assessment of Negative Symptoms (SANS)
|
-.8000 score on a scale
Standard Deviation 2.45531
|
-.1176 score on a scale
Standard Deviation 2.95555
|
Adverse Events
CBSST-CCT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Goal-focused Supportive Contact
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elizabeth W Twamley, PhD
Professor of Psychiatry, UC San Diego
Phone: 858-642-3848
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place