Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2018-04-01
2019-06-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Comparator
Commercially-available computerized training for 18 hours and 9 hours of unstructured support group sessions over a 9 week period.
Commercially available computerized training
Training on computerized, casual video games for 2 hours per week.
Unstructured support group sessions
Unstructured support group-video calls for 1 hour per week. The Specialist will not engage with participants (eg. providing participants with links to articles and additional support) or provide guidance for the group discussion.
Experimental Treatment
Computerized cognitive training for 18 hours and structured social skills training for 9 hours over a 9 week period.
Computerized Plasticity-Based Adaptive Cognitive Training
Training on computerized exercises that targets social cognition for 2 hours per week.
Optimized social skills training
Group-video calls with Specialist for 1 hour per week where participants can interact with Specialist individually or as a group. Specialist will provide guidance, support and feedback, and send links and articles about information and topics discussed during the video calls.
Interventions
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Computerized Plasticity-Based Adaptive Cognitive Training
Training on computerized exercises that targets social cognition for 2 hours per week.
Commercially available computerized training
Training on computerized, casual video games for 2 hours per week.
Optimized social skills training
Group-video calls with Specialist for 1 hour per week where participants can interact with Specialist individually or as a group. Specialist will provide guidance, support and feedback, and send links and articles about information and topics discussed during the video calls.
Unstructured support group sessions
Unstructured support group-video calls for 1 hour per week. The Specialist will not engage with participants (eg. providing participants with links to articles and additional support) or provide guidance for the group discussion.
Eligibility Criteria
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Inclusion Criteria
* Participant must be clinically stable (outpatient status for at least 2 months) at time of screening
* Participants taking psychiatric medications must be on a stable medication regimen for greater than or equal to 4 weeks prior to screening
* Participant must be a fluent English speaker
* Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse
* Participants must be able to use iOS mobile applications
Exclusion Criteria
* Participant has a history of mental retardation, pervasive developmental disorder, head trauma, traumatic brain injury, or other neurological disorder that impairs cognition
* Participants who have had psychiatric hospitalizations in the 8 weeks prior to randomization
* Participants had significant medication or clinical status changes, or adjustment in their antipsychotic treatment in the 4 weeks prior to randomization
* Participants with active suicidal ideations and/or behaviors as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Participants showing signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit
* Participants with problems performing assessments or comprehending or following spoken instructions
* Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study
* Participant is using computer-based cognitive training programs or has used it within a month of the consent date
18 Years
60 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Posit Science Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Bruno Biagianti, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Posit Science Corporation
Locations
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Posit Science Corporation
San Francisco, California, United States
Countries
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Other Identifiers
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PSC-1013-17
Identifier Type: -
Identifier Source: org_study_id
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