An interventional study of Cognitive remediation and Social Cognitive skills training in Schizoaffective Disorder and Schizophrenia, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-04-22.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 85 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
In addition, the subjects will meet the following criteria:
Exclusion Criteria:
cognitive remediation
Behavioral: Cognitive remediation
social cognitive skills training
Behavioral: Social Cognitive skills training
combined social cognitive and cognitive remediation training
Behavioral: hybrid intervention
control training
Behavioral: skills training
Computer exercises in attention, memory, and speed of processing.
Group training on emotion perception, social perception, and understanding others' mental states.
A combination of the two groups listed above.
Skills training in how to identify symptoms of illness and medication side effects.
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.
Time frame: Assessments for end point (12 weeks).
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.
Time frame: Assessments at endpoint (12 weeks).
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)
| Milestone | Social Cognition | Cognitive Remediation | Hybrid Group | Control - Social Skills Training |
|---|---|---|---|---|
| Started | 19 | 24 | 21 | 21 |
| Completed | 16 | 19 | 14 | 19 |
| Not completed | 3 | 5 | 7 | 2 |
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.
| number of correct answers | Social Cognitive Skills Training | Cognitive Remediation | Hybrid Intervention | Skills Training |
|---|---|---|---|---|
| Mean Test Scores for Facial Emotion Identification. | 45.5 ± 8.2 | 41.1 ± 12.1 | 43.8 ± 6.7 | 45.1 ± 5.0 |
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.
| number correct | Social Cognition | Cognitive Remediation | Hybrid Group | Control - Social Skills Training |
|---|---|---|---|---|
| Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities). | 3.43 ± .78 | 3.57 ± .74 | 3.35 ± 1.11 | 3.19 ± .86 |
Collected over October 2007 to September 2009. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Social Cognition | — | 0/19 (0%) | 0/19 (0%) |
| Cognitive Remediation | — | 1/24 (4.2%) | 0/24 (0%) |
| Hybrid Group | — | 2/21 (9.5%) | 1/21 (4.8%) |
| Control - Social Skills Training | — | 3/21 (14.3%) | 0/21 (0%) |
| Event | Social Cognition | Cognitive Remediation | Hybrid Group | Control - Social Skills Training |
|---|---|---|---|---|
| 5150 hold for suicidal thinking, aggressive behavior and exessive use of alcoholPsychiatric disorders | 0/19 | 0/24 | 1/21 | 0/21 |
| 5150 hold for relapse using cocaine and alcoholPsychiatric disorders | 0/19 | 0/24 | 0/21 | 1/21 |
| 5150 for threatening to sexually assault a female VeteranPsychiatric disorders | 0/19 | 0/24 | 1/21 | 0/21 |
| Subject was hospitalized for 8 days due to an inflammed pancreas.Endocrine disorders | 0/19 | 0/24 | 0/21 | 1/21 |
| 5150 hold for aggressive argument with his mother.Psychiatric disorders | 0/19 | 0/24 | 0/21 | 1/21 |
| MRSA cellulitis in both hands.Skin and subcutaneous tissue disorders | 0/19 | 1/24 | 0/21 | 0/21 |
| Event | Social Cognition | Cognitive Remediation | Hybrid Group | Control - Social Skills Training |
|---|---|---|---|---|
| ER visit for public intoxication.Psychiatric disorders | 0/19 | 0/24 | 1/21 | 0/21 |
| Age, Continuous(years) | Social Cognition | Cognitive Remediation | Hybrid Group | Control - Social Skills Training | Total |
|---|---|---|---|---|---|
| Mean | 51.0 ± 7.1 | 46.6 ± 7.4 | 50.4 ± 10.1 | 45.1 ± 11.2 | 48.4 ± 8.6 |
| Sex: Female, Male(Participants) | Social Cognition | Cognitive Remediation | Hybrid Group | Control - Social Skills Training | Total |
|---|---|---|---|---|---|
| Female | 1 | 2 | 1 | 4 | 8 |
| Male | 15 | 17 | 13 | 15 | 60 |
| Region of Enrollment(participants) | Social Cognition | Cognitive Remediation | Hybrid Group | Control - Social Skills Training | Total |
|---|---|---|---|---|---|
| United States | 16 | 19 | 14 | 19 | 68 |
| Affect perception(number of correct answers) | Social Cognition | Cognitive Remediation | Hybrid Group | Control - Social Skills Training | Total |
|---|---|---|---|---|---|
| Mean | 37.1 ± 6.1 | 40.6 ± 8.4 | 38.6 ± 8.3 | 43.4 ± 3.7 | 39.8 ± 7.0 |
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