Improving Basic and Social Cognition in Veterans With Schizophrenia (IBASC)
Behavioral: Cognitive remediation
Behavioral: Social Cognitive remediation
Behavioral: Combined cognitive and social cognitive remediation
Behavioral: Social skills training
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Improving Basic and Social Cognition in Veterans With Schizophrenia|
- The outcomes measures of interest include a summary of performance measures for basic cognition and a summary of scores for social cognition. [ Time Frame: Assessments will be conducted at baseline, 6 weeks, and 12 weeks of intervention ] [ Designated as safety issue: No ]
- Secondary measures include assessments of functional capacity (ability to perform daily activities) and electrophysiology (the N170 wave associated with face processing). [ Time Frame: These assessments will be conducted at baseline, 6 weeks, and 12 weeks. ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Patients with a chronic psychotic disorder
Behavioral: Cognitive remediation
Computer exercises in attention, memory, and speed of processing.Behavioral: Social Cognitive remediation
Group training on emotion perception, social perception, and understanding others' mental states.Behavioral: Combined cognitive and social cognitive remediation
A combination of the two groups listed above.Behavioral: Social skills training
Skills training in how to identify symptoms of illness and medication side effects.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|