Psychosis
Conditions
Keywords
social cognition, training intervention
Brief summary
Veterans with schizophrenia and schizoaffective disorder experience high levels of disability and poor community outcome, and these poor functional outcomes constitute a major public health concern. The treatment of schizophrenia spectrum disorders has shifted fundamentally from a focus on symptom reduction to a focus on recovery and improving aspects of functioning. Needed improvements in community outcome for patients with these disorders will not occur simply through better control of clinical symptoms. Instead, it is necessary to find new treatments that address the key determinants of poor functional outcome, including social cognition. Both basic (non-social) cognition and social cognition are considered key determinants of functional outcome for schizophrenia and schizoaffective disorder. Basic cognition includes the domains of: learning and memory, vigilance / attention, speed of processing, reasoning and problem solving, and working memory. Social cognition generally refers to mental operations that underlie social interactions, including perceiving, interpreting, managing, and generating responses to socially relevant stimuli, including the intentions and behaviors of others. As part of the investigators' previous Merit grant, they have developed a training program for social cognition and are in the process of validating it. Initial results suggest that the program improves performance on measures of social cognition and functional capacity. In this study, the investigators will evaluate whether adding an in vivo component (training activities that occur in the community) to the current social cognition intervention facilitates generalization of training effects to community outcome and subjective satisfaction. Outcome measures of social cognition and functional capacity will be examined during the 12 week training program, and durability of benefits will be assessed at a 3-month follow up. Generalization to community functioning and subjective satisfaction will be assessed at the end of training and at the 3-month follow up. The investigators will enroll 105 patients across the 5 years of the study with random assignment to training group (social cognition intervention with in vivo exercises, social cognition intervention without in vivo exercises and control). Subjects will receive assessments at baseline, 6 weeks (mid-point), completion of training (12 weeks), and the 3-month follow up.
Interventions
BEHAVIORALsocial cognitive training with in vivo augmentation
24 sessions of social cognitive training plus 6 sessions of in vivo exercises
BEHAVIORALsocial cognitive training
30 sessions of social cognitive training without in vivo exercises
BEHAVIORALnon-social skills training
30 sessions of skills training that has no specific social content
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
All patients must be diagnosed with Schizophrenia, Schizoaffective Disorder, or Psychosis not otherwise specified (NOS) according to Diagnosis and Statistical Manual (DSM-IV) criteria. In addition, the subjects will meet the following criteria: * Between 18 and 60 years of age * Estimated premorbid intelligence quota \> 70 (based on reading ability) * Understand spoken English sufficiently to comprehend testing procedures * Clinically stable (e.g., no inpatient hospitalization in the 8 weeks prior to enrollment, no significant changes in medication in the 4 weeks prior to enrollment, and none anticipated for the 3 months of participation) * In sufficient health to be able to walk outdoors unaided for at least 15 minutes.
Exclusion criteria
* No clinically significant neurological disease as determined by medical history * No history of serious head injury (e.g., loss of consciousness longer than 1 hour) * No physical, cognitive, or language impairment of such severity as to adversely affect the validity of data * No evidence of drug or alcohol dependence in the past six months, and not intoxicated at time of testing based on urine toxicology screen and saliva alcohol test strip. Subjects who test positive will not be disqualified but instead will be asked to return for testing on a different day. However, subjects who test positive on 3 consecutive occasions will be disqualified from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Awareness of Social Inference Test (TASIT) | 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. |
| Profile of Nonverbal Sensitivity (PONS) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 41 |
| Arm 2: Social Cognitive social cognitive training
social cognitive training: 30 sessions of social cognitive training without in vivo exercises | 47 |
| Arm 3: Non-social Skills non-social skills training
non-social skills training: 30 sessions of skills training that has no specific social content | 47 |
| Total | 135 |
Baseline characteristics
| Characteristic | Arm 1: Vivo Augmentation | Arm 2: Social Cognitive | Arm 3: Non-social Skills | Total |
|---|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 11.3 | 48.8 years STANDARD_DEVIATION 9.1 | 46.7 years STANDARD_DEVIATION 10.2 | 47.3 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 9 Participants | 21 Participants | 11 Participants | 41 Participants |
| Sex: Female, Male Male | 32 Participants | 26 Participants | 36 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 53 | 0 / 53 |
| serious Total, serious adverse events | 5 / 47 | 4 / 53 | 3 / 53 |
Outcome results
Primary
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
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.
Time frame: baseline, 6 weeks, 12 weeks, and 3 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Vivo Augmentation | Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | 6 weeks | 89.23 units on a scale | Standard Deviation 1.16 |
| Arm 1: Vivo Augmentation | Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | 12 weeks | 87.84 units on a scale | Standard Deviation 1.76 |
| Arm 1: Vivo Augmentation | Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | Baseline | 87.30 units on a scale | Standard Deviation 1.12 |
| Arm 1: Vivo Augmentation | Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | 3 months | 86.78 units on a scale | Standard Deviation 1.87 |
| Arm 2: Social Cognitive | Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | 6 weeks | 89.23 units on a scale | Standard Deviation 1.16 |
| Arm 2: Social Cognitive | Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | Baseline | 87.30 units on a scale | Standard Deviation 1.12 |
| Arm 2: Social Cognitive | Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | 12 weeks | 89.78 units on a scale | Standard Deviation 1.36 |
| Arm 2: Social Cognitive | Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | 3 months | 90.42 units on a scale | Standard Deviation 1.46 |
| Arm 3: Non-social Skills | Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | 12 weeks | 87.68 units on a scale | Standard Deviation 1.62 |
| Arm 3: Non-social Skills | Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | Baseline | 88.46 units on a scale | Standard Deviation 1.58 |
| Arm 3: Non-social Skills | Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | 6 weeks | 87.61 units on a scale | Standard Deviation 1.62 |
| Arm 3: Non-social Skills | Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) | 3 months | 86.51 units on a scale | Standard Deviation 1.87 |
Comparison: This is a statistical analysis to determine the training effect of social cognitive skills training (in vivo and social cog versus control).p-value: <0.05Mixed Models Analysis
Secondary
Profile of Nonverbal Sensitivity (PONS)
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.
Time frame: baseline, 6 weeks, 12 weeks, and 3 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Vivo Augmentation | Profile of Nonverbal Sensitivity (PONS) | baseline | 75.76 units on a scale | Standard Deviation 0.91 |
| Arm 1: Vivo Augmentation | Profile of Nonverbal Sensitivity (PONS) | 6 weeks | 78.90 units on a scale | Standard Deviation 0.79 |
| Arm 1: Vivo Augmentation | Profile of Nonverbal Sensitivity (PONS) | 12 weeks | 76.83 units on a scale | Standard Deviation 1.52 |
| Arm 1: Vivo Augmentation | Profile of Nonverbal Sensitivity (PONS) | 3 months | 76.72 units on a scale | Standard Deviation 1.94 |
| Arm 2: Social Cognitive | Profile of Nonverbal Sensitivity (PONS) | 3 months | 79.28 units on a scale | Standard Deviation 1.28 |
| Arm 2: Social Cognitive | Profile of Nonverbal Sensitivity (PONS) | baseline | 75.76 units on a scale | Standard Deviation 0.91 |
| Arm 2: Social Cognitive | Profile of Nonverbal Sensitivity (PONS) | 12 weeks | 78.60 units on a scale | Standard Deviation 1.04 |
| Arm 2: Social Cognitive | Profile of Nonverbal Sensitivity (PONS) | 6 weeks | 78.90 units on a scale | Standard Deviation 0.79 |
| Arm 3: Non-social Skills | Profile of Nonverbal Sensitivity (PONS) | 3 months | 80.56 units on a scale | Standard Deviation 1 |
| Arm 3: Non-social Skills | Profile of Nonverbal Sensitivity (PONS) | 6 weeks | 79.24 units on a scale | Standard Deviation 1.11 |
| Arm 3: Non-social Skills | Profile of Nonverbal Sensitivity (PONS) | 12 weeks | 79.89 units on a scale | Standard Deviation 1.16 |
| Arm 3: Non-social Skills | Profile of Nonverbal Sensitivity (PONS) | baseline | 77.41 units on a scale | Standard Deviation 1.16 |
p-value: <0.05Mixed Models Analysis
Secondary
The Awareness of Social Inference Test (TASIT)
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.
Time frame: baseline, 6 weeks, 12 weeks, and 3 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Vivo Augmentation | The Awareness of Social Inference Test (TASIT) | Baseline | 44.67 units on a scale | Standard Deviation 0.82 |
| Arm 1: Vivo Augmentation | The Awareness of Social Inference Test (TASIT) | 12 weeks | 46.00 units on a scale | Standard Deviation 1.24 |
| Arm 1: Vivo Augmentation | The Awareness of Social Inference Test (TASIT) | 3 months | 45.83 units on a scale | Standard Deviation 1.4 |
| Arm 1: Vivo Augmentation | The Awareness of Social Inference Test (TASIT) | 6 weeks | 45.45 units on a scale | Standard Deviation 0.77 |
| Arm 2: Social Cognitive | The Awareness of Social Inference Test (TASIT) | Baseline | 44.67 units on a scale | Standard Deviation 0.82 |
| Arm 2: Social Cognitive | The Awareness of Social Inference Test (TASIT) | 6 weeks | 45.45 units on a scale | Standard Deviation 0.77 |
| Arm 2: Social Cognitive | The Awareness of Social Inference Test (TASIT) | 12 weeks | 46.91 units on a scale | Standard Deviation 1.05 |
| Arm 2: Social Cognitive | The Awareness of Social Inference Test (TASIT) | 3 months | 46.91 units on a scale | Standard Deviation 1.05 |
| Arm 3: Non-social Skills | The Awareness of Social Inference Test (TASIT) | 12 weeks | 46.81 units on a scale | Standard Deviation 1.02 |
| Arm 3: Non-social Skills | The Awareness of Social Inference Test (TASIT) | Baseline | 46.79 units on a scale | Standard Deviation 0.93 |
| Arm 3: Non-social Skills | The Awareness of Social Inference Test (TASIT) | 6 weeks | 46.22 units on a scale | Standard Deviation 1.04 |
| Arm 3: Non-social Skills | The Awareness of Social Inference Test (TASIT) | 3 months | 46.73 units on a scale | Standard Deviation 1 |
p-value: <0.05Mixed Models Analysis