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Improving Basic and Social Cognition in Veterans With Schizophrenia (IBASC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00470106
First received: May 4, 2007
Last updated: March 22, 2016
Last verified: March 2016
Results First Received: October 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizoaffective Disorder
Schizophrenia
Interventions: Behavioral: Cognitive remediation
Behavioral: Social Cognitive skills training
Behavioral: hybrid intervention
Behavioral: skills training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from outpatient clinics at VA Greater Los Angeles Health care system and local mental health facilities. All patients met Diagnostic and Statistical Manual-IV criteria for schizophrenia, schizoaffective disorder, delusional disorder, or psychosis not otherwise specified (not secondary to substance use disorder)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This is not a drug study so there is no wash out or run in. Participants were excluded if they did not meet diagnostic criteria.

Reporting Groups
  Description
Social Cognition Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
Cognitive Remediation Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
Hybrid Group Half of the sessions were cognitive remediation and half were social cognitive training.
Control - Social Skills Training This group was a control for the amount of time in sessions. There was no social cognitive training.

Participant Flow:   Overall Study
    Social Cognition     Cognitive Remediation     Hybrid Group     Control - Social Skills Training  
STARTED     19     24     21     21  
COMPLETED     16     19     14     19  
NOT COMPLETED     3     5     7     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Social Cognition Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
Cognitive Remediation Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
Hybrid Group Half of the sessions were cognitive remediation and half were social cognitive training.
Control - Social Skills Training This group was a control for the amount of time in sessions. There was no social cognitive training.
Total Total of all reporting groups

Baseline Measures
    Social Cognition     Cognitive Remediation     Hybrid Group     Control - Social Skills Training     Total  
Number of Participants  
[units: participants]
  16     19     14     19     68  
Age  
[units: years]
Mean (Standard Deviation)
  51.0  (7.1)     46.6  (7.4)     50.4  (10.1)     45.1  (11.2)     48.4  (8.6)  
Gender  
[units: participants]
         
Female     1     2     1     4     8  
Male     15     17     13     15     60  
Region of Enrollment  
[units: participants]
         
United States     16     19     14     19     68  
Affect perception [1]
[units: number of correct answers]
Mean (Standard Deviation)
  37.1  (6.1)     40.6  (8.4)     38.6  (8.3)     43.4  (3.7)     39.8  (7.0)  
[1] This is a performance-based measure (range 0-56, with higher being better) in which subjects identify the emotion depicted in still photographs of faces. Number of correct identifications is the dependent measure.



  Outcome Measures
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1.  Primary:   Mean Test Scores for Facial Emotion Identification.   [ Time Frame: Assessments for end point (12 weeks). ]

2.  Secondary:   Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities).   [ Time Frame: Assessments at endpoint (12 weeks). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael F. Green, PhD
Organization: VA Greater Los Angeles
phone: (310)2693376
e-mail: michael.green6@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00470106     History of Changes
Other Study ID Numbers: MHBB-026-06S
Study First Received: May 4, 2007
Results First Received: October 14, 2015
Last Updated: March 22, 2016
Health Authority: United States: Federal Government