Intensive Computerized Brain Training (ICBT) in Youth With Early Onset Psychosis (EOP)
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| ClinicalTrials.gov Identifier: NCT01027962 |
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Recruitment Status
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Completed
First Posted
: December 9, 2009
Last Update Posted
: January 15, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psychosis | Other: ICBT Program | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 35 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Intensive Computerized Brain Training in Early Onset Psychosis-Pilot Phase |
| Study Start Date : | October 2009 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | January 2013 |
| Arm | Intervention/treatment |
|---|---|
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ICBT Program
Intensive Computerized Brain Training using software packages donated by Posit Science.
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Other: ICBT Program
Intensive Computerized Brain Training.
Other Name: Posit Science
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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.
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No Intervention: Healthy Control Group
No participation in computer activity.
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- Feasibility, Tolerability and Acceptability of Intensive Computerized Brain Training (ICBT) in youth with EOP. [ Time Frame: 2 years ]
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| Ages Eligible for Study: | 10 Years to 19 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
EOP participants:
- Clinical diagnosis of psychosis NOS, schizophrenia, schizoaffective, or schizophreniform disorder made by a child psychiatrist using DSM-IV criteria, confirmed by the KSADS (a semi-structured diagnostic interview) (Kaufman et al 1997)
- Age 10-19 years inclusive
- Guardian who is able and willing to participate in ongoing assessments and care
- Ongoing psychiatric care for EOP including medication treatment (except typical antipsychotic medication treatment)
Normal control participants:
- Age 10-19 years inclusive
- Guardian who is able and willing to participate in initial diagnostic assessment
Exclusion Criteria
EOP participants:
- Substance abuse within the month preceding treatment
- Hearing impairment that precludes participation in ICBT
- Visual impairment that precludes participation in ICBT
- Medical condition that is likely to impair learning or consciousness such as epilepsy or narcolepsy
- Lack of fluency in English language
- Severe psychotic symptoms that prevent quiet activity for up to 90 minutes at time
- Treatment with typical antipsychotic treatment
- Wide Range Achievement Test (WRAT (Wilkinson 1993)) word reading subscale grade equivalent of 2.9 or lower.
- Known history of premorbid developmental delay or learning disability
- Severe psychotic symptoms that prevent quiet activity for up to 90 minutes at time
Normal control participants:
- KSADS current or past diagnosis of psychiatric disorder including schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder, major depression, obsessive compulsive disorder, panic disorder, post traumatic stress disorder, Tourette's disorder, eating disorder, borderline personality disorder, autism spectrum disorder, attention deficit disorder
- Family history in first or second degree relative of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder, major depression, substance abuse, obsessive compulsive disorder, panic disorder, post traumatic stress disorder, Tourette's disorder, eating disorder, borderline personality disorder, autism spectrum disorder
- Substance use within the month preceding treatment
- Psychotropic medication treatment
- Hearing impairment that precludes participation in ICBT
- Visual impairment that precludes participation in ICBT
- Medical condition that is likely to impair learning or consciousness such as epilepsy or narcolepsy
- Lack of fluency in English language
- Severe psychotic symptoms that prevent quiet activity for up to 90 minutes at time
- Wide Range Achievement Test (WRAT (Wilkinson 1993)) word reading subscale grade equivalent of 2.9 or lower.
- Known history of premorbid developmental delay or learning disability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Linmarie Sikich, MD, Associate Professor, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01027962 History of Changes |
| Other Study ID Numbers: |
UNC # 09-0637; Maine #3589 R34MH085888-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 9, 2009 Key Record Dates |
| Last Update Posted: | January 15, 2013 |
| Last Verified: | January 2013 |
Keywords provided by Linmarie Sikich, MD, University of North Carolina, Chapel Hill:
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Early Onset Psychosis Laptop Computer Brain Training |
Additional relevant MeSH terms:
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Psychotic Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders |