Intensive Computerized Brain Training (ICBT) in Youth With Early Onset Psychosis (EOP)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intensive Computerized Brain Training in Early Onset Psychosis-Pilot Phase|
- Feasibility, Tolerability and Acceptability of Intensive Computerized Brain Training (ICBT) in youth with EOP. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Intensive Computerized Brain Training using software packages donated by Posit Science.
Other: ICBT Program
Intensive Computerized Brain Training.
Other Name: Posit Science
No Intervention: Control Intervention
Commercially available computer games that do not contain violent stimuli but are appealing to youth between 10 and 19 years of age.
No Intervention: Healthy Control Group
No participation in computer activity.
The purpose of this study is to provide a foundation for future rigorous study of an intervention that translates what we know about refinement of synaptic connections in response to environmental stimuli to an individualized intervention that directly improves neurocognitive functioning in youths with early onset psychosis(EOP). We will conduct a pilot randomized control study that determines the feasibility, tolerability and acceptability of Intensive Computerized Brain Training (ICBT) in youth with EOP.
Participants: Seventy youths, aged 10 years to 19 years inclusive will be assessed in the study. Forty youths with EOP will be randomly assigned to ICBT or an equally intense computerized game activity and 20 will be age, gender and race matched youths with no major psychiatric illnesses. We will allow for up to 5 EOP screen failures and up to 5 healthy control screen failures.
Procedures (methods): The forty participants with EOP will be randomly assigned to treatment with ICBT or equally intense video game play that also involves attention to sensory stimuli and requires increasingly skilled responses. A computer generated randomization schedule will be used to make assignments. Outcomes will be assessed at baseline, completion of the intervention (typically week 20), 3 after completing the intervention (typically month 8) and 7 months after completing the intervention(typically month 12). The other 20 youths, who comprise the typically developing comparison group known as healthy controls, will not participate in the computer activity or regular monthly psychiatric visits and will not complete satisfaction questionnaires. Up to 10 subjects may not be eligible to participate in the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027962
|United States, North Carolina|
|University of North Carolina, Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Lin Sikich, MD||University of North Carolina, Chapel Hill|
|Principal Investigator:||Ann Maloney, MD||Maine Medical Center Research Institute|