Social Cognition Intervention (ASCI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01267019
First received: December 23, 2010
Last updated: July 8, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: Baseline, 6 weeks, 12 weeks, and 3 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267019

Contacts
Contact: Michael F Green, PhD (310) 268-3376 Michael.Green6@va.gov

Locations
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         
Sponsors and Collaborators
Investigators
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: July 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
social cognition
training intervention

ClinicalTrials.gov processed this record on October 16, 2014