Social Cognition Intervention

Psychosis Clinical Trial

— ASCI  

Official title:

Augmenting Social Cognitive Intervention for Veterans With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267019
• Other study ID #: MHBB-004-10S
• Status: Completed
• Phase: N/A
• First received: December 23, 2010
• Last updated: April 22, 2016
• Start date: February 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychosis

Intervention

Behavioral:
• social cognitive training with in vivo augmentation
24 sessions of social cognitive training plus 6 sessions of in vivo exercises
• social cognitive training
30 sessions of social cognitive training without in vivo exercises
• non-social skills training
30 sessions of skills training that has no specific social content

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MATRICS Consensus Cognitive Battery (MCCB)		Baseline, 6 weeks, 12 weeks, and 3 months.	No
Secondary	Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)		baseline, 6 weeks, 12 weeks, and 3 months.	No
Secondary	The Awareness of Social Inference Test (TASIT)		baseline, 6 weeks, 12 weeks, and 3 months.	No
Secondary	Profile of Nonverbal Sensitivity (PONS)		baseline, 6 weeks, 12 weeks, and 3 months.	No
Secondary	The Maryland Assessment of Social Competence (MASC).		Baseline, 6 weeks, 12 weeks, and 3 months.	No