Improving Basic and Social Cognition in Veterans With Schizophrenia (IBASC)
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|ClinicalTrials.gov Identifier: NCT00470106|
Recruitment Status : Completed
First Posted : May 7, 2007
Results First Posted : April 22, 2016
Last Update Posted : April 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Schizoaffective Disorder Schizophrenia||Behavioral: Cognitive remediation Behavioral: Social Cognitive skills training Behavioral: hybrid intervention Behavioral: skills training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Basic and Social Cognition in Veterans With Schizophrenia|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Active Comparator: Cognitive Remediation
Behavioral: Cognitive remediation
Computer exercises in attention, memory, and speed of processing.
Experimental: Social Cognitive Skills Training
social cognitive skills training
Behavioral: Social Cognitive skills training
Group training on emotion perception, social perception, and understanding others' mental states.
Active Comparator: Hybrid Intervention
combined social cognitive and cognitive remediation training
Behavioral: hybrid intervention
A combination of the two groups listed above.
Behavioral: skills training
Skills training in how to identify symptoms of illness and medication side effects.
- Mean Test Scores for Facial Emotion Identification. [ Time Frame: Assessments for end point (12 weeks). ]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.
- Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities). [ Time Frame: Assessments at endpoint (12 weeks). ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470106
|United States, California|
|VA Greater Los Angeles Healthcare System, West Los Angeles, CA|
|West Los Angeles, California, United States, 90073|
|Principal Investigator:||Michael F Green, PhD||VA Greater Los Angeles Healthcare System, West Los Angeles, CA|