Trial Outcomes & Findings for USS Training to Improve Social Function in People With Psychosis (NCT NCT04557124)
NCT ID: NCT04557124
Last Updated: 2025-10-15
Results Overview
The SFS is one of the best known measures of social functioning in schizophrenia, and was one of two social function measures nominated by experts and selected by a RAND panel for a large-scale investigation of measures to assess real-world outcomes based on its psychometric properties, sensitivity to change, relationship to symptoms, and comprehensiveness. The total score ranges from 55 to 135, with a higher score indicates better social functioning. Score change at post-testing (2 months) and follow-up (4 months) was calculated by subtracting the baseline score, with negative values indicating worse and positive values indicating better social functioning compared to baseline. Mid-testing (1 month) score change was included in the mixed-effects model, but its least square mean was not calculated as it was not a time point of interest.
COMPLETED
NA
113 participants
Post-testing (2 months) and follow-up (4 months)
2025-10-15
Participant Flow
After obtaining consent but before randomization, 5 participants withdrew and 5 participants did not meet the inclusion criteria.
Participant milestones
| Measure |
Understanding Social Situations (USS)
social cognitive training
USS: social cognitive training
|
Moving Forward (MF)
problem solving training
MovingForward: problem solving training
|
|---|---|---|
|
Allocation (Baseline)
STARTED
|
53
|
50
|
|
Allocation (Baseline)
COMPLETED
|
53
|
49
|
|
Allocation (Baseline)
NOT COMPLETED
|
0
|
1
|
|
Mid-point (1 Month)
STARTED
|
53
|
49
|
|
Mid-point (1 Month)
COMPLETED
|
47
|
43
|
|
Mid-point (1 Month)
NOT COMPLETED
|
6
|
6
|
|
Post-testing (2 Months)
STARTED
|
52
|
47
|
|
Post-testing (2 Months)
COMPLETED
|
49
|
39
|
|
Post-testing (2 Months)
NOT COMPLETED
|
3
|
8
|
|
Follow-up (4 Months)
STARTED
|
50
|
44
|
|
Follow-up (4 Months)
COMPLETED
|
48
|
43
|
|
Follow-up (4 Months)
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Understanding Social Situations (USS)
social cognitive training
USS: social cognitive training
|
Moving Forward (MF)
problem solving training
MovingForward: problem solving training
|
|---|---|---|
|
Allocation (Baseline)
Withdrawal by Subject
|
0
|
1
|
|
Mid-point (1 Month)
Missed testing
|
5
|
4
|
|
Mid-point (1 Month)
Lost to Follow-up
|
1
|
2
|
|
Post-testing (2 Months)
Missed testing
|
1
|
5
|
|
Post-testing (2 Months)
Lost to Follow-up
|
2
|
3
|
|
Follow-up (4 Months)
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
USS Training to Improve Social Function in People With Psychosis
Baseline characteristics by cohort
| Measure |
Understanding Social Situations (USS)
n=53 Participants
Social cognitive training
USS: social cognitive training
|
Moving Forward (MF)
n=50 Participants
Problem solving training
Moving Forward: problem solving training
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=99 Participants
|
61 years
n=107 Participants
|
60 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Social Functioning Scale (SFS)
|
105.57 units on a scale
n=99 Participants
|
107.32 units on a scale
n=107 Participants
|
105.79 units on a scale
n=206 Participants
|
|
Social Skill Performance Assessment (SSPA)
|
7.42 units on a scale
n=99 Participants
|
7.38 units on a scale
n=107 Participants
|
7.42 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: Post-testing (2 months) and follow-up (4 months)Population: An intention-to-treat analysis, including all randomized participants, was performed. A mixed-effects model was used to include all data points from randomization onward.
The SFS is one of the best known measures of social functioning in schizophrenia, and was one of two social function measures nominated by experts and selected by a RAND panel for a large-scale investigation of measures to assess real-world outcomes based on its psychometric properties, sensitivity to change, relationship to symptoms, and comprehensiveness. The total score ranges from 55 to 135, with a higher score indicates better social functioning. Score change at post-testing (2 months) and follow-up (4 months) was calculated by subtracting the baseline score, with negative values indicating worse and positive values indicating better social functioning compared to baseline. Mid-testing (1 month) score change was included in the mixed-effects model, but its least square mean was not calculated as it was not a time point of interest.
Outcome measures
| Measure |
Understanding Social Situations (USS)
n=53 Participants
social cognitive training
USS: social cognitive training
|
Moving Forward (MF)
n=50 Participants
problem solving training
MovingForward: problem solving training
|
|---|---|---|
|
Social Functioning Scale (SFS) Change
Post-testing (2 months)
|
1.28 score on a scale
Interval -0.04 to 2.59
|
0.19 score on a scale
Interval -1.22 to 1.6
|
|
Social Functioning Scale (SFS) Change
Follow-up (4 months)
|
1.56 score on a scale
Interval 0.11 to 3.01
|
0.32 score on a scale
Interval -1.18 to 1.81
|
SECONDARY outcome
Timeframe: Post-training (2 months) and follow-up (4 months).Population: An intention-to-treat analysis, including all randomized participants, was performed. A mixed-effects model was used to include all data points from randomization onward.
SSPA is a role-play measure of social skill ability. It consists of two, 3-minute, structured role plays (tenant meeting a new neighbor; tenant calling landlord to request repair). Each role play is rated between 1 and 5. The total score is calculated by summing up the ratings, and ranges from 2 to 10. A higher score indicates better social skill performance. Score change at post-testing (2 months) and follow-up (4 months) was calculated by subtracting the baseline score, with negative values indicating worse and positive values indicating better social skill performance compared to baseline.
Outcome measures
| Measure |
Understanding Social Situations (USS)
n=53 Participants
social cognitive training
USS: social cognitive training
|
Moving Forward (MF)
n=50 Participants
problem solving training
MovingForward: problem solving training
|
|---|---|---|
|
Social Skills Performance Assessment (SSPA) Change
Post-training (2 months)
|
0.01 score on a scale
Interval -0.21 to 0.22
|
-0.11 score on a scale
Interval -0.34 to 0.12
|
|
Social Skills Performance Assessment (SSPA) Change
Follow-up (4 months)
|
0.00 score on a scale
Interval -0.21 to 0.22
|
-0.03 score on a scale
Interval -0.24 to 0.18
|
Adverse Events
Understanding Social Situations (USS)
Moving Forward (MF)
Serious adverse events
| Measure |
Understanding Social Situations (USS)
n=53 participants at risk
social cognitive training USS: social cognitive training
|
Moving Forward (MF)
n=50 participants at risk
problem solving training MovingForward: problem solving training
|
|---|---|---|
|
Cardiac disorders
Heart failure exacerbation
|
1.9%
1/53 • Number of events 1 • Up to 4 months.
|
2.0%
1/50 • Number of events 1 • Up to 4 months.
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/53 • Up to 4 months.
|
2.0%
1/50 • Number of events 1 • Up to 4 months.
|
|
Psychiatric disorders
Delusions/Psychosis
|
1.9%
1/53 • Number of events 1 • Up to 4 months.
|
2.0%
1/50 • Number of events 1 • Up to 4 months.
|
|
Nervous system disorders
Tremor
|
1.9%
1/53 • Number of events 1 • Up to 4 months.
|
0.00%
0/50 • Up to 4 months.
|
|
Psychiatric disorders
Suicide ideation
|
0.00%
0/53 • Up to 4 months.
|
2.0%
1/50 • Number of events 1 • Up to 4 months.
|
|
Nervous system disorders
Transient ischemic attacks
|
1.9%
1/53 • Number of events 1 • Up to 4 months.
|
0.00%
0/50 • Up to 4 months.
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/53 • Up to 4 months.
|
2.0%
1/50 • Number of events 1 • Up to 4 months.
|
|
General disorders
Fatigue
|
0.00%
0/53 • Up to 4 months.
|
2.0%
1/50 • Number of events 1 • Up to 4 months.
|
|
Musculoskeletal and connective tissue disorders
Sprain and strain of ankle
|
0.00%
0/53 • Up to 4 months.
|
2.0%
1/50 • Number of events 1 • Up to 4 months.
|
|
Psychiatric disorders
Substance use
|
1.9%
1/53 • Number of events 1 • Up to 4 months.
|
0.00%
0/50 • Up to 4 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/53 • Number of events 1 • Up to 4 months.
|
0.00%
0/50 • Up to 4 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Joanna Fiszdon, Principal Investigator
VA Connecticut Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place