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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Behavioral: Cognitive remediation; Behavioral: Social Cognitive skills training; Behavioral: hybrid intervention; Behavioral: skills training

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • West Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive Remediation; 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.
Other: Skills Training; control training	Behavioral: skills training; Skills training in how to identify symptoms of illness and medication side effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessments for end point (12 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessments at endpoint (12 weeks).

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Michael F Green, PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: May 4, 2007
• First Submitted That Met QC Criteria: May 4, 2007
• First Posted (Estimate): May 7, 2007

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: March 22, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Schizophrenia; Cognition; Social Cognition; Remediation
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: MHBB-026-06S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided