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

NCT ID: NCT01027962

Last Updated: 2013-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-01-31

Brief Summary

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.

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.

Conditions

Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICBT Program

Intensive Computerized Brain Training using software packages donated by Posit Science.

Group Type: OTHER

ICBT Program

Intervention Type: OTHER

Intensive Computerized Brain Training.

Control Intervention

Commercially available computer games that do not contain violent stimuli but are appealing to youth between 10 and 19 years of age.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Control Group

No participation in computer activity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ICBT Program

Intensive Computerized Brain Training.

Intervention Type: OTHER

Other Intervention Names

Posit Science

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation of Hope, North Carolina

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Linmarie Sikich, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lin Sikich, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Ann Maloney, MD

Role: PRINCIPAL_INVESTIGATOR

MaineHealth

Locations

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

R34MH085888-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UNC # 09-0637; Maine #3589

Identifier Type: -

Identifier Source: org_study_id