Creating Live Interactions to Mitigate Barriers | NCT03317769

NCT03317769

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
National Institute of Mental Health (NIMH)	NIH

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Treatment	Experimental	Computerized cognitive training for 18 hours and structured social skills training for 9 hours over a 9 week period.	Other: Computerized Plasticity-Based Adaptive Cognitive Training Other: Optimized social skills training
Active Comparator	Active Comparator	Commercially-available computerized training for 18 hours and 9 hours of unstructured support group sessions over a 9 week period.	Other: Commercially available computerized training Other: Unstructured support group sessions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computerized Plasticity-Based Adaptive Cognitive Training	Other	Training on computerized exercises that targets social cognition for 2 hours per week.	Experimental Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Social Functioning utilizing the Social Functioning Scale.	Between-group magnitude of change in social functioning utilizing the Social Functioning Scale. The Social Functioning Scale (SFS) was constructed specifically to tap areas of social functioning that are crucial to the community maintenance of individuals with schizophrenia. The 7 domains include: social engagement/withdrawal, interpersonal behavior, pro-social activities, recreation, independence-competence, independence-performance, and employment/occupation. The raw scores for each domain are converted to scaled scores, with a mean of 100 and a standard deviation of 15. Higher scores are indicative of greater social functioning.	At 9 weeks
Negative Symptoms utilizing the Positive and Negative Syndrome Scale.	Between-group magnitude of change in negative symptoms utilizing the Positive and Negative Syndrome Scale. The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. A rating from 1 to 7 is given to each of the 30 different symptoms. The 7-point rating represents increasing levels of psychopathology: 1= absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale. The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. Higher scores are indicative of greater symptomatology.	At 9 weeks
Quality of Life utilizing the Abbreviated Quality of Life Scale.	Between-group magnitude of change in quality of life utilizing the Abbreviated Quality of Life Scale. The Quality of Life Scale (QLS) is a scale commonly used as a measure of functioning in schizophrenia. The Abbreviated QLS (aQLS) includes 7 items representing all four interdependent theoretical constructs of the original 21-item QLS. Behavioral anchors are presented for each item, scored on a 0 (severe impairment) to 6 (high functioning) scale. Higher scores are indicative of greater quality of life.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must have a clinical diagnosis of Schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and confirmed by the Structured Clinical Interview for DSM-5 (SCID)
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:

Participants with unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, cardiovascular, endocrine, neurologic disorder, epilepsy, recent hospitalization, ongoing chemotherapy or other cancer treatment
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

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders