Intensive Computerized Brain Training (ICBT) in Youth With Early Onset Psychosis (EOP)

This study has been completed.
Sponsor:
Collaborators:
Foundation of Hope, North Carolina
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01027962
First received: December 7, 2009
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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 youths aged 10-19 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.


Condition Intervention
Psychosis
Other: ICBT Program

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Feasibility, Tolerability and Acceptability of Intensive Computerized Brain Training (ICBT) in youth with EOP. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: October 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ICBT Program
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027962

Locations
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Foundation of Hope, North Carolina
Investigators
Principal Investigator: Lin Sikich, MD University of North Carolina, Chapel Hill
Principal Investigator: Ann Maloney, MD Maine Medical Center Research Institute
  More Information

No publications provided

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
Study First Received: December 7, 2009
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Early Onset Psychosis
Laptop Computer
Brain Training

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 23, 2014