Trial Outcomes & Findings for Social Cognition Intervention (NCT NCT01267019)
NCT ID: NCT01267019
Last Updated: 2017-03-15
Results Overview
A standardized measure of emotion processing. It is scored as a standard score with a population mean of 100 and standard deviation of 15. It can range from 0 to 200. Higher is better. Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
153 participants
Primary outcome timeframe
baseline, 6 weeks, 12 weeks, and 3 months.
Results posted on
2017-03-15
Participant Flow
Participant milestones
| Measure |
Arm 1: Vivo Augmentation
social cognitive training with in vivo augmentation
social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises
|
Arm 2: Social Cognitive
social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises
|
Arm 3: Non-social Skills
non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
53
|
53
|
|
Overall Study
COMPLETED
|
41
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Social Cognition Intervention
Baseline characteristics by cohort
| Measure |
Arm 1: Vivo Augmentation
n=41 Participants
social cognitive training with in vivo augmentation
social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises
|
Arm 2: Social Cognitive
n=47 Participants
social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises
|
Arm 3: Non-social Skills
n=47 Participants
non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
48.8 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeks, and 3 months.A standardized measure of emotion processing. It is scored as a standard score with a population mean of 100 and standard deviation of 15. It can range from 0 to 200. Higher is better. Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.
Outcome measures
| Measure |
Arm 1: Vivo Augmentation
n=41 Participants
social cognitive training with in vivo augmentation
social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises
|
Arm 2: Social Cognitive
n=47 Participants
social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises
|
Arm 3: Non-social Skills
n=47 Participants
non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content
|
|---|---|---|---|
|
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Baseline
|
87.30 units on a scale
Standard Deviation 1.12
|
87.30 units on a scale
Standard Deviation 1.12
|
88.46 units on a scale
Standard Deviation 1.58
|
|
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
6 weeks
|
89.23 units on a scale
Standard Deviation 1.16
|
89.23 units on a scale
Standard Deviation 1.16
|
87.61 units on a scale
Standard Deviation 1.62
|
|
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
12 weeks
|
87.84 units on a scale
Standard Deviation 1.76
|
89.78 units on a scale
Standard Deviation 1.36
|
87.68 units on a scale
Standard Deviation 1.62
|
|
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
3 months
|
86.78 units on a scale
Standard Deviation 1.87
|
90.42 units on a scale
Standard Deviation 1.46
|
86.51 units on a scale
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeks, and 3 months.A measure of mentalizing (i.e., making inferences about other people). It is scored for accuracy in which higher is better. It ranges from 0 - 64. Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.
Outcome measures
| Measure |
Arm 1: Vivo Augmentation
n=41 Participants
social cognitive training with in vivo augmentation
social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises
|
Arm 2: Social Cognitive
n=47 Participants
social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises
|
Arm 3: Non-social Skills
n=47 Participants
non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content
|
|---|---|---|---|
|
The Awareness of Social Inference Test (TASIT)
Baseline
|
44.67 units on a scale
Standard Deviation .82
|
44.67 units on a scale
Standard Deviation .82
|
46.79 units on a scale
Standard Deviation .93
|
|
The Awareness of Social Inference Test (TASIT)
6 weeks
|
45.45 units on a scale
Standard Deviation .77
|
45.45 units on a scale
Standard Deviation .77
|
46.22 units on a scale
Standard Deviation 1.04
|
|
The Awareness of Social Inference Test (TASIT)
12 weeks
|
46.00 units on a scale
Standard Deviation 1.24
|
46.91 units on a scale
Standard Deviation 1.05
|
46.81 units on a scale
Standard Deviation 1.02
|
|
The Awareness of Social Inference Test (TASIT)
3 months
|
45.83 units on a scale
Standard Deviation 1.4
|
46.91 units on a scale
Standard Deviation 1.05
|
46.73 units on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeks, and 3 months.A measure of social perception. It is scored as number correct and higher is better. It ranges from 0 - 110. Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.
Outcome measures
| Measure |
Arm 1: Vivo Augmentation
n=41 Participants
social cognitive training with in vivo augmentation
social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises
|
Arm 2: Social Cognitive
n=47 Participants
social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises
|
Arm 3: Non-social Skills
n=47 Participants
non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content
|
|---|---|---|---|
|
Profile of Nonverbal Sensitivity (PONS)
baseline
|
75.76 units on a scale
Standard Deviation .91
|
75.76 units on a scale
Standard Deviation .91
|
77.41 units on a scale
Standard Deviation 1.16
|
|
Profile of Nonverbal Sensitivity (PONS)
6 weeks
|
78.90 units on a scale
Standard Deviation .79
|
78.90 units on a scale
Standard Deviation .79
|
79.24 units on a scale
Standard Deviation 1.11
|
|
Profile of Nonverbal Sensitivity (PONS)
12 weeks
|
76.83 units on a scale
Standard Deviation 1.52
|
78.60 units on a scale
Standard Deviation 1.04
|
79.89 units on a scale
Standard Deviation 1.16
|
|
Profile of Nonverbal Sensitivity (PONS)
3 months
|
76.72 units on a scale
Standard Deviation 1.94
|
79.28 units on a scale
Standard Deviation 1.28
|
80.56 units on a scale
Standard Deviation 1.00
|
Adverse Events
Arm 1: Vivo Augmentation
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Social Cognitive
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3: Non-social Skills
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Vivo Augmentation
n=47 participants at risk
social cognitive training with in vivo augmentation
social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises
|
Arm 2: Social Cognitive
n=53 participants at risk
social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises
|
Arm 3: Non-social Skills
n=53 participants at risk
non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content
|
|---|---|---|---|
|
Psychiatric disorders
acute exacerbation of symptoms
|
10.6%
5/47 • Number of events 5
|
5.7%
3/53 • Number of events 3
|
3.8%
2/53 • Number of events 2
|
|
Cardiac disorders
cardiac arrest
|
0.00%
0/47
|
1.9%
1/53 • Number of events 1
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
diabetic incident
|
0.00%
0/47
|
0.00%
0/53
|
1.9%
1/53 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Michael F. Green, PhD
VA Greater Los Angeles, VISN 22 MIRECC
Phone: (310) 268-3376
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place