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

NCT01027962 | Completed

• 2 other identifiers: UNC # 09-0637; Maine #3589R34MH085888-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis

Keywords

Early Onset Psychosis; Laptop Computer; Brain Training

Outcome Measures

Primary Outcomes (1)

• Feasibility, Tolerability and Acceptability of Intensive Computerized Brain Training (ICBT) in youth with EOP.

  2 years

Study Arms (3)

ICBT Program

OTHER

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

Other: ICBT Program

Control Intervention

NO INTERVENTION

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

Healthy Control Group

NO INTERVENTION

No participation in computer activity.

Interventions

ICBT Program OTHER

Intensive Computerized Brain Training.

Also known as: Posit Science

ICBT Program

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Foundation of Hope, North Carolina: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Lin Sikich, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Ann Maloney, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

US (1)