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Improving Basic and Social Cognition in Veterans With Schizophrenia (IBASC)

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00470106
First received: May 4, 2007
Last updated: September 4, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Schizoaffective Disorder
Schizophrenia
Behavioral: Cognitive remediation
Behavioral: Social Cognitive remediation
Behavioral: Combined cognitive and social cognitive remediation
Behavioral: Social skills training

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
Study Start Date: September 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must be diagnosed with Schizophrenia, Schizoaffective Disorder, or Psychosis NOS according to DSM-IV criteria.
  • In addition, the subjects will meet the following criteria:

    • Between 18 and 60 years of age
    • Estimated premorbid IQ > 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470106

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Green, PhD VA Greater Los Angeles Healthcare System, West LA
  More Information

Publications:

Responsible Party: Green, Michael - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00470106     History of Changes
Other Study ID Numbers: MHBB-026-06S
Study First Received: May 4, 2007
Last Updated: September 4, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cognition
Remediation
Schizophrenia
Social Cognition

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 25, 2014