Improving Basic and Social Cognition in Veterans With Schizophrenia (IBASC)
Primary Purpose
Schizoaffective Disorder, Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive remediation
Social Cognitive skills training
hybrid intervention
skills training
Sponsored by
About this trial
This is an interventional treatment trial for Schizoaffective Disorder focused on measuring Cognition, Remediation, Schizophrenia, Social Cognition
Eligibility Criteria
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:
- Between 18 and 60 years of age
- Estimated premorbid intelligence quotient > 70 (based on reading ability)
- Understand spoken English sufficiently to comprehend testing procedures
- Clinically stable (e.g., no inpatient hospitalization in the 8 weeks prior to enrollment, no significant changes in medication in the 6 weeks prior to enrollment, and none anticipated for the 3 months of participation)
Exclusion Criteria:
- No clinically significant neurological disease as determined by medical history
- No history of serious head injury (e.g., loss of consciousness longer than 1 hour)
- No physical, cognitive, or language impairment of such severity as to adversely affect the validity of data
- No evidence of drug or alcohol dependence in the past six months, and not intoxicated at time of testing
- The patients psychotic experiences can be explained solely by the use of drugs or alcohol
Sites / Locations
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Active Comparator
Other
Arm Label
Cognitive Remediation
Social Cognitive Skills Training
Hybrid Intervention
Skills Training
Arm Description
cognitive remediation
social cognitive skills training
combined social cognitive and cognitive remediation training
control training
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00470106
First Posted
May 4, 2007
Last Updated
March 22, 2016
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00470106
Brief Title
Improving Basic and Social Cognition in Veterans With Schizophrenia
Acronym
IBASC
Official Title
Improving Basic and Social Cognition in Veterans With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizoaffective Disorder, Schizophrenia
Keywords
Cognition, Remediation, Schizophrenia, Social Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Remediation
Arm Type
Active Comparator
Arm Description
cognitive remediation
Arm Title
Social Cognitive Skills Training
Arm Type
Experimental
Arm Description
social cognitive skills training
Arm Title
Hybrid Intervention
Arm Type
Active Comparator
Arm Description
combined social cognitive and cognitive remediation training
Arm Title
Skills Training
Arm Type
Other
Arm Description
control training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation
Intervention Description
Computer exercises in attention, memory, and speed of processing.
Intervention Type
Behavioral
Intervention Name(s)
Social Cognitive skills training
Intervention Description
Group training on emotion perception, social perception, and understanding others' mental states.
Intervention Type
Behavioral
Intervention Name(s)
hybrid intervention
Intervention Description
A combination of the two groups listed above.
Intervention Type
Behavioral
Intervention Name(s)
skills training
Intervention Description
Skills training in how to identify symptoms of illness and medication side effects.
Primary Outcome Measure Information:
Title
Mean Test Scores for Facial Emotion Identification.
Description
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).
Secondary Outcome Measure Information:
Title
Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities).
Description
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Between 18 and 60 years of age
Estimated premorbid intelligence quotient > 70 (based on reading ability)
Understand spoken English sufficiently to comprehend testing procedures
Clinically stable (e.g., no inpatient hospitalization in the 8 weeks prior to enrollment, no significant changes in medication in the 6 weeks prior to enrollment, and none anticipated for the 3 months of participation)
Exclusion Criteria:
No clinically significant neurological disease as determined by medical history
No history of serious head injury (e.g., loss of consciousness longer than 1 hour)
No physical, cognitive, or language impairment of such severity as to adversely affect the validity of data
No evidence of drug or alcohol dependence in the past six months, and not intoxicated at time of testing
The patients psychotic experiences can be explained solely by the use of drugs or alcohol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael F Green, PhD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21377168
Citation
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.
Results Reference
result
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Improving Basic and Social Cognition in Veterans With Schizophrenia
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