ICBT-PI

Study Name: Intensive Computerized Brain Training in Early Onset Psychosis-Pilot Phase

IRB # 09-0637

PI: Linmarie Sikich, MD

Sponsor: National Institute of Mental Health (NIMH)

Contact Person: Lindsey Hazzard

Phone: 1-800-708-0048

E-mail: ASPIRE@unc.edu

Brief Description

The purpose of this study is to examine whether an intensive computerized intervention targeted on improving central auditory and visual processing and executive functioning can be implemented in youth 10-17 with psychotic spectrum disorders, what developmental modifications are needed particularly for the younger participants, and whether it is possible to develop an appropriate, blinded control intervention. Ultimately we seek to develop nonpharmacologic strategies for improving neurocognition and overall functioning in youth with schizophrenia.

Subject Payment

Up to $650 for EOSS participants and up to $225 for Healthy Control participants

Major inclusion criteria for early onset psychosis (EOP) participants

  • Clinical diagnosis of schizophrenia, schizoaffective disorder , schizophreniform disorder, Psychosis NOS 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, if applicable, who is able and willing to participate in ongoing assessments and care
  • Ongoing psychiatric care for EOP

Major exclusion criteria for early onset psychosis (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
  • Wide Range Achievement Test (WRAT (Wilkinson 1993)) word reading subscale grade equivalent of 2.9 or lower.
  • Known history of premorbid developmental delay
  • Severe psychotic symptoms that prevent quiet activity for up to 90 minutes at time

Major inclusion criteria for healthy control participants

  • Age 10-19 years inclusive
  • Guardian, if applicable, who is able and willing to participate in initial diagnostic assessment

Major exclusion criteria for healthy 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 degree relative of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, 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
  • Wide Range Achievement Test (WRAT (Wilkinson 1993)) word reading subscale grade equivalent of 2.9 or lower.
  • Known history of premorbid developmental delay

Site of study

UNC Neurosciences Hospital DNC clinic

Target enrollment

60 youth, ages 10 years to 19 years inclusive will be assessed in the study. Forty youth with EOSS will be randomly assigned to ICBT or an equally intense computerized game activity and 20 will be age, gender and race matched youth with no major psychiatric illnesses.

Date enrollment closes

TBD

Additional Study Resources

ICBT-PI Study Brochure

National Institute of Mental Health