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

Psychosis Clinical Trial

Official title:

Intensive Computerized Brain Training in Early Onset Psychosis-Pilot Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027962
• Other study ID #: UNC # 09-0637; Maine #3589
• Secondary ID: R34MH085888-01
• Status: Completed
• Phase: N/A
• First received: December 7, 2009
• Last updated: January 14, 2013
• Start date: October 2009
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Other:
• ICBT Program
Intensive Computerized Brain Training.

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Foundation of Hope, North Carolina, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, Tolerability and Acceptability of Intensive Computerized Brain Training (ICBT) in youth with EOP.		2 years	No