N/A
N=85
Improving Basic and Social Cognition in Veterans With Schizophrenia
Schizoaffective Disorder · Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00470106 ↗Enrolled (actual)
85
Serious AEs
7.1%
Results posted
Apr 2016
Primary outcome: Primary: Mean Test Scores for Facial Emotion Identification. — 45.5; 41.1; 43.8; 45.1 number of correct answers — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive remediation (Behavioral); Social Cognitive skills training (Behavioral); hybrid intervention (Behavioral); skills training (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Test Scores for Facial Emotion Identification. |
45.5; 41.1; 43.8; 45.1 | <.001 sig |
| SECONDARY Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities). |
3.43; 3.57; 3.35; 3.19 | <.10 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00470106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.