Trial Outcomes & Findings for Improving Basic and Social Cognition in Veterans With Schizophrenia (NCT NCT00470106)
NCT ID: NCT00470106
Last Updated: 2016-04-22
Results Overview
This is a test of social cognition that measures the ability to identify the emotion shown in photos of still faces. The construct of interest is facial affect perception. It is an experimental measure and does not have norms or cut-offs. The range of accuracy scores is 0-56 with higher being better.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
Assessments for end point (12 weeks).
Results posted on
2016-04-22
Participant Flow
Participants were recruited from outpatient clinics at VA Greater Los Angeles Health care system and local mental health facilities. All patients met Diagnostic and Statistical Manual-IV criteria for schizophrenia, schizoaffective disorder, delusional disorder, or psychosis not otherwise specified (not secondary to substance use disorder)
This is not a drug study so there is no wash out or run in. Participants were excluded if they did not meet diagnostic criteria.
Participant milestones
| Measure |
Social Cognition
Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
|
Cognitive Remediation
Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
|
Hybrid Group
Half of the sessions were cognitive remediation and half were social cognitive training.
|
Control - Social Skills Training
This group was a control for the amount of time in sessions. There was no social cognitive training.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
24
|
21
|
21
|
|
Overall Study
COMPLETED
|
16
|
19
|
14
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Basic and Social Cognition in Veterans With Schizophrenia
Baseline characteristics by cohort
| Measure |
Social Cognition
n=16 Participants
Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
|
Cognitive Remediation
n=19 Participants
Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
|
Hybrid Group
n=14 Participants
Half of the sessions were cognitive remediation and half were social cognitive training.
|
Control - Social Skills Training
n=19 Participants
This group was a control for the amount of time in sessions. There was no social cognitive training.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 7.1 • n=99 Participants
|
46.6 years
STANDARD_DEVIATION 7.4 • n=107 Participants
|
50.4 years
STANDARD_DEVIATION 10.1 • n=206 Participants
|
45.1 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 8.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
19 participants
n=107 Participants
|
14 participants
n=206 Participants
|
19 participants
n=7 Participants
|
68 participants
n=31 Participants
|
|
Affect perception
|
37.1 number of correct answers
STANDARD_DEVIATION 6.1 • n=99 Participants
|
40.6 number of correct answers
STANDARD_DEVIATION 8.4 • n=107 Participants
|
38.6 number of correct answers
STANDARD_DEVIATION 8.3 • n=206 Participants
|
43.4 number of correct answers
STANDARD_DEVIATION 3.7 • n=7 Participants
|
39.8 number of correct answers
STANDARD_DEVIATION 7.0 • n=31 Participants
|
PRIMARY outcome
Timeframe: Assessments for end point (12 weeks).This is a test of social cognition that measures the ability to identify the emotion shown in photos of still faces. The construct of interest is facial affect perception. It is an experimental measure and does not have norms or cut-offs. The range of accuracy scores is 0-56 with higher being better.
Outcome measures
| Measure |
Social Cognitive Skills Training
n=16 Participants
social cognitive skills training
Social Cognitive skills training: Group training on emotion perception, social perception, and understanding others' mental states.
|
Cognitive Remediation
n=19 Participants
cognitive remediation
Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
|
Hybrid Intervention
n=14 Participants
combined social cognitive and cognitive remediation training
hybrid intervention: A combination of the two groups listed above.
|
Skills Training
n=19 Participants
control training
skills training: Skills training in how to identify symptoms of illness and medication side effects.
|
|---|---|---|---|---|
|
Mean Test Scores for Facial Emotion Identification.
|
45.5 number of correct answers
Standard Deviation 8.2
|
41.1 number of correct answers
Standard Deviation 12.1
|
43.8 number of correct answers
Standard Deviation 6.7
|
45.1 number of correct answers
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Assessments at endpoint (12 weeks).This is a role play demonstration test that measures how well someone handles social communication in daily life. The scores reflect overall effectiveness and are the mean number scored across different social situations with a range of 0-5 with higher being better. There are no norms for this test.
Outcome measures
| Measure |
Social Cognitive Skills Training
n=16 Participants
social cognitive skills training
Social Cognitive skills training: Group training on emotion perception, social perception, and understanding others' mental states.
|
Cognitive Remediation
n=19 Participants
cognitive remediation
Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
|
Hybrid Intervention
n=14 Participants
combined social cognitive and cognitive remediation training
hybrid intervention: A combination of the two groups listed above.
|
Skills Training
n=19 Participants
control training
skills training: Skills training in how to identify symptoms of illness and medication side effects.
|
|---|---|---|---|---|
|
Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities).
|
3.43 number correct
Standard Deviation .78
|
3.57 number correct
Standard Deviation .74
|
3.35 number correct
Standard Deviation 1.11
|
3.19 number correct
Standard Deviation .86
|
Adverse Events
Social Cognition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Remediation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Hybrid Group
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Control - Social Skills Training
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Social Cognition
n=19 participants at risk
Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
|
Cognitive Remediation
n=24 participants at risk
Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
|
Hybrid Group
n=21 participants at risk
Half of the sessions were cognitive remediation and half were social cognitive training.
|
Control - Social Skills Training
n=21 participants at risk
This group was a control for the amount of time in sessions. There was no social cognitive training.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
MRSA cellulitis in both hands.
|
0.00%
0/19 • October 2007 to September 2009
|
4.2%
1/24 • Number of events 1 • October 2007 to September 2009
|
0.00%
0/21 • October 2007 to September 2009
|
0.00%
0/21 • October 2007 to September 2009
|
|
Psychiatric disorders
5150 hold for suicidal thinking, aggressive behavior and exessive use of alcohol
|
0.00%
0/19 • October 2007 to September 2009
|
0.00%
0/24 • October 2007 to September 2009
|
4.8%
1/21 • Number of events 1 • October 2007 to September 2009
|
0.00%
0/21 • October 2007 to September 2009
|
|
Psychiatric disorders
5150 hold for relapse using cocaine and alcohol
|
0.00%
0/19 • October 2007 to September 2009
|
0.00%
0/24 • October 2007 to September 2009
|
0.00%
0/21 • October 2007 to September 2009
|
4.8%
1/21 • Number of events 1 • October 2007 to September 2009
|
|
Psychiatric disorders
5150 for threatening to sexually assault a female Veteran
|
0.00%
0/19 • October 2007 to September 2009
|
0.00%
0/24 • October 2007 to September 2009
|
4.8%
1/21 • Number of events 1 • October 2007 to September 2009
|
0.00%
0/21 • October 2007 to September 2009
|
|
Endocrine disorders
Subject was hospitalized for 8 days due to an inflammed pancreas.
|
0.00%
0/19 • October 2007 to September 2009
|
0.00%
0/24 • October 2007 to September 2009
|
0.00%
0/21 • October 2007 to September 2009
|
4.8%
1/21 • Number of events 1 • October 2007 to September 2009
|
|
Psychiatric disorders
5150 hold for aggressive argument with his mother.
|
0.00%
0/19 • October 2007 to September 2009
|
0.00%
0/24 • October 2007 to September 2009
|
0.00%
0/21 • October 2007 to September 2009
|
4.8%
1/21 • Number of events 1 • October 2007 to September 2009
|
Other adverse events
| Measure |
Social Cognition
n=19 participants at risk
Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
|
Cognitive Remediation
n=24 participants at risk
Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
|
Hybrid Group
n=21 participants at risk
Half of the sessions were cognitive remediation and half were social cognitive training.
|
Control - Social Skills Training
n=21 participants at risk
This group was a control for the amount of time in sessions. There was no social cognitive training.
|
|---|---|---|---|---|
|
Psychiatric disorders
ER visit for public intoxication.
|
0.00%
0/19 • October 2007 to September 2009
|
0.00%
0/24 • October 2007 to September 2009
|
4.8%
1/21 • Number of events 1 • October 2007 to September 2009
|
0.00%
0/21 • October 2007 to September 2009
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place