Improving Basic and Social Cognition in Veterans With Schizophrenia

Schizophrenia Clinical Trial

— IBASC  

Official title:

Improving Basic and Social Cognition in Veterans With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470106
• Other study ID #: MHBB-026-06S
• Status: Completed
• Phase: N/A
• First received: May 4, 2007
• Last updated: June 26, 2015
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: June 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Cognitive remediation
Computer exercises in attention, memory, and speed of processing.
• Social Cognitive remediation
Group training on emotion perception, social perception, and understanding others' mental states.
• Combined cognitive and social cognitive remediation
A combination of the two groups listed above.
• Social skills training
Skills training in how to identify symptoms of illness and medication side effects.

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The outcomes measures of interest include a summary of performance measures for basic cognition and a summary of scores for social cognition.		Assessments will be conducted at baseline, 6 weeks, and 12 weeks of intervention	No
Secondary	Secondary measures include assessments of functional capacity (ability to perform daily activities) and electrophysiology (the N170 wave associated with face processing).		These assessments will be conducted at baseline, 6 weeks, and 12 weeks.	No