Improving Basic and Social Cognition in Veterans With Schizophrenia
IBASC
1 other identifier
interventional
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2007
CompletedFirst Posted
Study publicly available on registry
May 7, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
April 22, 2016
CompletedApril 22, 2016
March 1, 2016
2 years
May 4, 2007
October 14, 2015
March 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities).
Assessments at endpoint (12 weeks).
Study Arms (4)
Cognitive Remediation
ACTIVE COMPARATORcognitive remediation
Social Cognitive Skills Training
EXPERIMENTALsocial cognitive skills training
Hybrid Intervention
ACTIVE COMPARATORcombined social cognitive and cognitive remediation training
Skills Training
OTHERcontrol training
Interventions
Computer exercises in attention, memory, and speed of processing.
Group training on emotion perception, social perception, and understanding others' mental states.
Skills training in how to identify symptoms of illness and medication side effects.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073, United States
Related Publications (1)
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.
PMID: 21377168RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael F. Green, PhD
- Organization
- VA Greater Los Angeles
Study Officials
- PRINCIPAL INVESTIGATOR
Michael F Green, PhD
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2007
First Posted
May 7, 2007
Study Start
September 1, 2007
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
April 22, 2016
Results First Posted
April 22, 2016
Record last verified: 2016-03