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Social Cognition Intervention (ASCI)

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ClinicalTrials.gov Identifier: NCT01267019
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

December 23, 2010
December 24, 2010
November 15, 2016
March 15, 2017
March 15, 2017
February 2011
December 2015   (Final data collection date for primary outcome measure)
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) [ Time Frame: baseline, 6 weeks, 12 weeks, and 3 months. ]

A standardized measure of emotion processing. It is scored as a standard score with a population mean of 100 and standard deviation of 15. It can range from 0 to 200. Higher is better.

Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.

MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: baseline, 6 weeks, 12 weeks, and 3 months. ]
Complete list of historical versions of study NCT01267019 on ClinicalTrials.gov Archive Site
  • The Awareness of Social Inference Test (TASIT) [ Time Frame: baseline, 6 weeks, 12 weeks, and 3 months. ]

    A measure of mentalizing (i.e., making inferences about other people). It is scored for accuracy in which higher is better. It ranges from 0 - 64.

    Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.

  • Profile of Nonverbal Sensitivity (PONS) [ Time Frame: baseline, 6 weeks, 12 weeks, and 3 months. ]

    A measure of social perception. It is scored as number correct and higher is better. It ranges from 0 - 110.

    Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.

  • Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) [ Time Frame: baseline, 6 weeks, 12 weeks, and 3 months. ]
  • The Awareness of Social Inference Test (TASIT) [ Time Frame: baseline, 6 weeks, 12 weeks, and 3 months. ]
  • Profile of Nonverbal Sensitivity (PONS) [ Time Frame: baseline, 6 weeks, 12 weeks, and 3 months. ]
  • The Maryland Assessment of Social Competence (MASC). [ Time Frame: Baseline, 6 weeks, 12 weeks, and 3 months. ]
Not Provided
Not Provided
 
Social Cognition Intervention
Augmenting Social Cognitive Intervention for Veterans With Schizophrenia

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 the investigators' previous Merit grant, they 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, the investigators 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. The investigators 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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Psychosis
  • Behavioral: social cognitive training with in vivo augmentation
    24 sessions of social cognitive training plus 6 sessions of in vivo exercises
  • Behavioral: social cognitive training
    30 sessions of social cognitive training without in vivo exercises
  • Behavioral: non-social skills training
    30 sessions of skills training that has no specific social content
  • Experimental: Arm 1: vivo augmentation
    social cognitive training with in vivo augmentation
    Intervention: Behavioral: social cognitive training with in vivo augmentation
  • Active Comparator: Arm 2: social cognitive
    social cognitive training
    Intervention: Behavioral: social cognitive training
  • Active Comparator: Arm 3: non-social skills
    non-social skills training
    Intervention: Behavioral: non-social skills training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
105
December 2015
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

All patients must be diagnosed with Schizophrenia, Schizoaffective Disorder, or Psychosis not otherwise specified (NOS) according to Diagnosis and Statistical Manual (DSM-IV) criteria. In addition, the subjects will meet the following criteria:

  • Between 18 and 60 years of age
  • Estimated premorbid intelligence quota > 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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01267019
MHBB-004-10S
Yes
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Michael F Green, PhD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
VA Office of Research and Development
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP