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Veterans with schizophrenia and schizoaffective disorder experience very high levels of disability and poor community outcome. Further improvements in community outcome for patients with these disorders will not occur simply through better control of clinical symptoms. Instead, it will be necessary to find treatments that address the key determinants of poor functional outcome. Evidence strongly suggests that basic (non-social) cognitive and social cognitive deficits are among the key determinants of functional outcome for these illnesses. The primary goal of this 2-year pilot study is to implement and validate a new remediation program for social cognition that is appropriate for veterans with schizophrenia and schizoaffective disorder.
Veterans with schizophrenia and schizoaffective disorder experience very high levels of disability and poor community outcome. Further improvements in community outcome for patients with these disorders will not occur simply through better control of clinical symptoms. Instead, it will be necessary to find treatments that address the key determinants of poor functional outcome. Evidence strongly suggests that basic (non-social) cognitive and social cognitive deficits are among the key determinants of functional outcome for these illnesses. The primary goal of this 2-year pilot study is to implement and validate a new remediation program for social cognition that is appropriate for veterans with schizophrenia and schizoaffective disorder.
We plan to recruit 72 patients over the 2 years of the study from the outpatient clinics at the VA Greater Los Angeles Healthcare System (VAGLAHS). They will receive baseline assessment that includes measures of social cognition, basic cognition, electrophysiology, functional capacity, clinical symptoms, community status, and demographics / clinical history. Follow up assessments will be administered at the mid-point of training (at 6 weeks) and end of training (at 12 weeks). Each follow up assessment will include measures of basic cognition, social cognition, electrophysiology, functional capacity, and clinical symptoms. The tester administering the assessments will be blind to treatment group.
Subjects will be randomly assigned to one of four groups: 1) social cognitive training, 2) basic cognitive remediation, 3) a combined social cognitive and basic cognitive intervention, or 4) social skills training. All groups will meet in one-hour sessions held twice a week over the course of 12 weeks in small groups of 3-6. The Social Cognition Intervention (SCI) is a new 24-session, manualized intervention program specifically designed to improve emotion perception, social context processing, and theory of mind / attributional bias in veterans with schizophrenia and schizoaffective disorder. The Basic Cognitive Intervention (BCI) will involve computer-assisted training exercises. Each participant will work individually on a notebook computer. The combined intervention will cover the same content areas as the social cognitive and basic cognitive interventions, but will not go into as much detail as the separate intervention programs. The control condition will be facilitated discussion of current events. Treatment will be administered in a group format with three to six patients and a training coach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Remediation | Active Comparator | cognitive remediation |
|
| Social Cognitive Skills Training | Experimental | social cognitive skills training |
|
| Hybrid Intervention | Active Comparator | combined social cognitive and cognitive remediation training |
|
| Skills Training | Other | control training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive remediation | Behavioral | Computer exercises in attention, memory, and speed of processing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Test Scores for Facial Emotion Identification. | 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. | Assessments for end point (12 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities). | 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. | Assessments at endpoint (12 weeks). |
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Inclusion Criteria:
All patients must be diagnosed with Schizophrenia, Schizoaffective Disorder, or Psychosis not otherwise specified according to Diagnosis and Statistical Manual-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 |
|---|---|---|---|
| 21377168 | Result | Horan WP, Kern RS, Tripp C, Hellemann G, Wynn JK, Bell M, Marder SR, Green MF. Efficacy and specificity of social cognitive skills training for outpatients with psychotic disorders. J Psychiatr Res. 2011 Aug;45(8):1113-22. doi: 10.1016/j.jpsychires.2011.01.015. Epub 2011 Mar 4. |
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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.
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)
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| ID | Title | Description |
|---|---|---|
| FG000 | Social Cognition | Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states. |
| FG001 | Cognitive Remediation | Cognitive remediation: Computer exercises in attention, memory, and speed of processing. |
| FG002 | Hybrid Group | Half of the sessions were cognitive remediation and half were social cognitive training. |
| FG003 | Control - Social Skills Training | This group was a control for the amount of time in sessions. There was no social cognitive training. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Social Cognition | Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states. |
| BG001 | Cognitive Remediation |
| 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 | Mean Test Scores for Facial Emotion Identification. | 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. | Posted | Mean | Standard Deviation | number of correct answers | Assessments for end point (12 weeks). |
|
October 2007 to September 2009
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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 | Social Cognition | Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MRSA cellulitis in both hands. | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER visit for public intoxication. | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael F. Green, PhD | VA Greater Los Angeles | (310)2693376 | michael.green6@va.gov |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000072466 | Cognitive Remediation |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Social Cognitive skills training | Behavioral | Group training on emotion perception, social perception, and understanding others' mental states. |
|
| hybrid intervention | Behavioral | A combination of the two groups listed above. |
|
| skills training | Behavioral | Skills training in how to identify symptoms of illness and medication side effects. |
|
Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
| BG002 | Hybrid Group | Half of the sessions were cognitive remediation and half were social cognitive training. |
| BG003 | Control - Social Skills Training | This group was a control for the amount of time in sessions. There was no social cognitive training. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Affect perception | This is a performance-based measure (range 0-56, with higher being better) in which subjects identify the emotion depicted in still photographs of faces. Number of correct identifications is the dependent measure. | Mean | Standard Deviation | number of correct answers |
|
cognitive remediation
Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
| OG002 | Hybrid Intervention | combined social cognitive and cognitive remediation training hybrid intervention: A combination of the two groups listed above. |
| OG003 | Skills Training | control training skills training: Skills training in how to identify symptoms of illness and medication side effects. |
|
|
|
| Secondary | Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities). | 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. | Posted | Mean | Standard Deviation | number correct | Assessments at endpoint (12 weeks). |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Cognitive Remediation | Cognitive remediation: Computer exercises in attention, memory, and speed of processing. | 1 | 24 | 0 | 24 |
| EG002 | Hybrid Group | Half of the sessions were cognitive remediation and half were social cognitive training. | 2 | 21 | 1 | 21 |
| EG003 | Control - Social Skills Training | This group was a control for the amount of time in sessions. There was no social cognitive training. | 3 | 21 | 0 | 21 |
| 5150 hold for suicidal thinking, aggressive behavior and exessive use of alcohol | Psychiatric disorders | Non-systematic Assessment |
|
| 5150 hold for relapse using cocaine and alcohol | Psychiatric disorders | Non-systematic Assessment |
|
| 5150 for threatening to sexually assault a female Veteran | Psychiatric disorders | Non-systematic Assessment |
|
| Subject was hospitalized for 8 days due to an inflammed pancreas. | Endocrine disorders | Non-systematic Assessment |
|
| 5150 hold for aggressive argument with his mother. | Psychiatric disorders | Non-systematic Assessment |
|
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