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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: vivo augmentation | Experimental | social cognitive training with in vivo augmentation |
|
| Arm 2: social cognitive | Active Comparator | social cognitive training |
|
| Arm 3: non-social skills | Active Comparator | non-social skills training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| social cognitive training with in vivo augmentation | Behavioral | 24 sessions of social cognitive training plus 6 sessions of in vivo exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 6 weeks, 12 weeks, and 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 6 weeks, 12 weeks, and 3 months. |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael F Green, PhD | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29300973 | Derived | Horan WP, Dolinsky M, Lee J, Kern RS, Hellemann G, Sugar CA, Glynn SM, Green MF. Social Cognitive Skills Training for Psychosis With Community-Based Training Exercises: A Randomized Controlled Trial. Schizophr Bull. 2018 Oct 17;44(6):1254-1266. doi: 10.1093/schbul/sbx167. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Arm 2: Social Cognitive | social cognitive training social cognitive training: 30 sessions of social cognitive training without in vivo exercises |
| FG002 | Arm 3: Non-social Skills | non-social skills training non-social skills training: 30 sessions of skills training that has no specific social content |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Arm 2: Social Cognitive |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 weeks, 12 weeks, and 3 months. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute exacerbation of symptoms | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael F. Green, PhD | VA Greater Los Angeles, VISN 22 MIRECC | (310) 268-3376 | mgreen@ucla.edu |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| social cognitive training | Behavioral | 30 sessions of social cognitive training without in vivo exercises |
|
| non-social skills training | Behavioral | 30 sessions of skills training that has no specific social content |
|
| 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. | baseline, 6 weeks, 12 weeks, and 3 months. |
social cognitive training social cognitive training: 30 sessions of social cognitive training without in vivo exercises |
| BG002 | Arm 3: Non-social Skills | non-social skills training non-social skills training: 30 sessions of skills training that has no specific social content |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
social cognitive training social cognitive training: 30 sessions of social cognitive training without in vivo exercises |
| OG002 | Arm 3: Non-social Skills | non-social skills training non-social skills training: 30 sessions of skills training that has no specific social content |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 weeks, 12 weeks, and 3 months. |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 weeks, 12 weeks, and 3 months. |
|
|
|
|
| 5 |
| 47 |
| 0 |
| 47 |
| EG001 | Arm 2: Social Cognitive | social cognitive training social cognitive training: 30 sessions of social cognitive training without in vivo exercises | 4 | 53 | 0 | 53 |
| EG002 | Arm 3: Non-social Skills | non-social skills training non-social skills training: 30 sessions of skills training that has no specific social content | 3 | 53 | 0 | 53 |
| cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| diabetic incident | Metabolism and nutrition disorders | Non-systematic Assessment |
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| 12 weeks |
|
| 3 months |
|
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| 12 weeks |
|
| 3 months |
|