Social Cognition Intervention (ASCI)
Primary Purpose
Psychosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
social cognitive training with in vivo augmentation
social cognitive training
non-social skills training
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis focused on measuring social cognition, training intervention
Eligibility Criteria
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.
Sites / Locations
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Arm 1: vivo augmentation
Arm 2: social cognitive
Arm 3: non-social skills
Arm Description
social cognitive training with in vivo augmentation
social cognitive training
non-social skills training
Outcomes
Primary Outcome Measures
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
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.
Secondary Outcome Measures
The Awareness of Social Inference Test (TASIT)
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)
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.
Full Information
NCT ID
NCT01267019
First Posted
December 23, 2010
Last Updated
January 24, 2017
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01267019
Brief Title
Social Cognition Intervention
Acronym
ASCI
Official Title
Augmenting Social Cognitive Intervention for Veterans With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
social cognition, training intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: vivo augmentation
Arm Type
Experimental
Arm Description
social cognitive training with in vivo augmentation
Arm Title
Arm 2: social cognitive
Arm Type
Active Comparator
Arm Description
social cognitive training
Arm Title
Arm 3: non-social skills
Arm Type
Active Comparator
Arm Description
non-social skills training
Intervention Type
Behavioral
Intervention Name(s)
social cognitive training with in vivo augmentation
Intervention Description
24 sessions of social cognitive training plus 6 sessions of in vivo exercises
Intervention Type
Behavioral
Intervention Name(s)
social cognitive training
Intervention Description
30 sessions of social cognitive training without in vivo exercises
Intervention Type
Behavioral
Intervention Name(s)
non-social skills training
Intervention Description
30 sessions of skills training that has no specific social content
Primary Outcome Measure Information:
Title
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks, and 3 months.
Secondary Outcome Measure Information:
Title
The Awareness of Social Inference Test (TASIT)
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks, and 3 months.
Title
Profile of Nonverbal Sensitivity (PONS)
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks, and 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael F Green, PhD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29300973
Citation
Horan WP, Dolinsky M, Lee J, Kern RS, Hellemann G, Sugar CA, Glynn SM, Green MF. Social Cognitive Skills Training for Psychosis With Community-Based Training Exercises: A Randomized Controlled Trial. Schizophr Bull. 2018 Oct 17;44(6):1254-1266. doi: 10.1093/schbul/sbx167.
Results Reference
derived
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Social Cognition Intervention
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