Social Cognition Intervention (ASCI)
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Purpose
Veterans with schizophrenia and schizoaffective disorder experience high levels of disability and poor community outcome, and these poor functional outcomes constitute a major public health concern. The treatment of schizophrenia spectrum disorders has shifted fundamentally from a focus on symptom reduction to a focus on recovery and improving aspects of functioning. Needed improvements in community outcome for patients with these disorders will not occur simply through better control of clinical symptoms. Instead, it is necessary to find new treatments that address the key determinants of poor functional outcome, including social cognition. Both basic (non-social) cognition and social cognition are considered key determinants of functional outcome for schizophrenia and schizoaffective disorder. Basic cognition includes the domains of: learning and memory, vigilance / attention, speed of processing, reasoning and problem solving, and working memory. Social cognition generally refers to mental operations that underlie social interactions, including perceiving, interpreting, managing, and generating responses to socially relevant stimuli, including the intentions and behaviors of others. As part of our previous Merit grant, we have developed a training program for social cognition and are in the process of validating it. Initial results suggest that the program improves performance on measures of social cognition and functional capacity.
In this study, we will evaluate whether adding an in vivo component (training activities that occur in the community) to the current social cognition intervention facilitates generalization of training effects to community outcome and subjective satisfaction. Outcome measures of social cognition and functional capacity will be examined during the 12 week training program, and durability of benefits will be assessed at a 3-month follow up. Generalization to community functioning and subjective satisfaction will be assessed at the end of training and at the 3-month follow up. We will enroll 105 patients across the 5 years of the study with random assignment to training group (social cognition intervention with in vivo exercises, social cognition intervention without in vivo exercises and control). Subjects will receive assessments at baseline, 6 weeks (mid-point), completion of training (12 weeks), and the 3-month follow up.
Meaningful steps toward achieving improved functional outcome in schizophrenia and schizoaffective disorder require understanding how generalization of training programs can be enhanced. The ultimate goal of this research program is to improve community outcome for veterans with psychotic disorders by addressing the determinants of functional outcome.
| Condition | Intervention |
|---|---|
|
Psychosis |
Behavioral: social cognitive training with in vivo augmentation Behavioral: social cognitive training Behavioral: non-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: | Augmenting Social Cognitive Intervention for Veterans With Schizophrenia |
- MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: Baseline, 6 weeks, 12 weeks, and 3 months. ] [ Designated as safety issue: No ]
- Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) [ Time Frame: baseline, 6 weeks, 12 weeks, and 3 months. ] [ Designated as safety issue: No ]
- The Awareness of Social Inference Test (TASIT) [ Time Frame: baseline, 6 weeks, 12 weeks, and 3 months. ] [ Designated as safety issue: No ]
- Profile of Nonverbal Sensitivity (PONS) [ Time Frame: baseline, 6 weeks, 12 weeks, and 3 months. ] [ Designated as safety issue: No ]
- The Maryland Assessment of Social Competence (MASC). [ Time Frame: Baseline, 6 weeks, 12 weeks, and 3 months. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 105 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
social cognitive training with in vivo augmentation
|
Behavioral: social cognitive training with in vivo augmentation
24 sessions of social cognitive training plus 6 sessions of in vivo exercises
|
|
Active Comparator: Arm 2
social cognitive training
|
Behavioral: social cognitive training
30 sessions of social cognitive training without in vivo exercises
|
|
Active Comparator: Arm 3
non-social skills training
|
Behavioral: non-social skills training
30 sessions of skills training that has no specific social content
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 4 weeks prior to enrollment, and none anticipated for the 3 months of participation)
In sufficient health to be able to walk outdoors unaided for at least 15 minutes.
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 based on urine toxicology screen and saliva alcohol test strip. Subjects who test positive will not be disqualified but instead will be asked to return for testing on a different day. However, subjects who test positive on 3 consecutive occasions will be disqualified from the study.
Contacts and Locations| Contact: Michael F Green, PhD | (310) 268-3376 | Michael.Green6@va.gov |
| United States, California | |
| VA Greater Los Angeles Healthcare System, West LA | Recruiting |
| West Los Angeles, California, United States, 90073 | |
| Contact: Michael F Green, PhD 310-268-3376 Michael.Green6@va.gov | |
| Principal Investigator: Michael F. Green, PhD | |
| Principal Investigator: | Michael F. Green, PhD | VA Greater Los Angeles Healthcare System, West LA |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01267019 History of Changes |
| Other Study ID Numbers: | MHBB-004-10S |
| Study First Received: | December 23, 2010 |
| Last Updated: | March 7, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
social cognition training intervention |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on May 22, 2013