Effects of Cognitive Remediation on Cognition in Young People at Clinical High Risk of Psychosis

NCT01619319 | Completed DMC

• 1 other identifier: Cognitive Remediation in CHR
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Onset of psychotic disorders such as schizophrenia, typically occurs during late adolescence or early adulthood often resulting in chronic social and occupational disability. Deficits in cognition and functional outcome often precede the onset of full-blown psychosis although to a lesser degree than observed in schizophrenia. Recent progress in risk identification methodology has enabled reliable detection of persons who appear to be putatively prodromal for psychosis, that is, at clinical high risk (CHR) of developing a psychotic disorder. Since these CHR individuals already evidence cognitive deficits, which increase around the time of conversion, cognition is an excellent treatment target. Furthermore, there is clear evidence, in schizophrenia and in CHR samples, that deficits in cognition are related to poor functional outcome. Thus, treatments targeting cognition may consequently improve functional outcome. The primary aim of the project is to reduce cognitive deterioration and improve cognition among youths at CHR using cognitive remediation and to test the effectiveness of a new cognitive remediation program, the Brain Fitness program, in improving cognition of CHR individuals. A control treatment consisting of video games (VG) will be used. The primary hypothesis is that the BF group will have improved cognition at the end of treatment and 12 months post baseline compared to the VG group. A secondary hypothesis is that improved cognition will be associated with improved functioning. This is a longitudinal, single blind, placebo controlled pilot trial of cognitive remediation in 36 CHR persons. Participants will be randomised to either the BF or VG program, which will be administered over a period of 3 months. Assessments will occur at baseline, post treatment (3 months) and at 12 months after baseline. All subjects will be recruited in year 1 of the project and treatment will be completed by 15 months. The 40 hours of training will occur 4 days a week, for an hour each day, over a period of 10 -12 weeks.

Conditions

Prodromal Schizophrenia

Keywords

schizophrenia prodrome; clinical high risk of psychosis

Outcome Measures

Primary Outcomes (1)

• Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)

  MATRICS will be used to assess changes in cognition at the end of treatment and 12 months post baseline.

  12 months

Secondary Outcomes (1)

• GFS= Global Functioning Scale (GFS): Social and Role

  12 months

Study Arms (2)

Cognitive Remediation Therapy

EXPERIMENTAL

A computerised cognitive remediation intervention called the Brain Fitness program is compared against a placebo intervention consisting of computer games

Other: Cognitive Remediation Therapy

computer games

ACTIVE COMPARATOR

computer games

Other: computer games

Interventions

Cognitive Remediation Therapy OTHER

auditory computer games designed to improve the speed at which people react when they hear something and at which they process that information.

Also known as: Brain Fitness Program

Cognitive Remediation Therapy

computer games OTHER

computer games that that consist of word puzzles

Also known as: Hoyle Puzzle and Board Games

computer games

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female between 12 and 35 years old.
• Understand and sign an informed consent (or assent for minors) document in English.
• Must meet the NAPLS substance use criteria (see guidelines).
• Meet diagnostic criteria for prodromal syndrome as per COPS Criteria (see below) or if under 19 meet criteria for schizotypal personality disorder.

You may not qualify if:

• Meet criteria for current or lifetime Axis I psychotic disorder, including affective psychoses and psychosis NOS.
• No current treatment with antipsychotic medication unless it can be clearly demonstrated that the diagnostic prodromal criteria were present prior to the antipsychotic.
• Impaired intellectual functioning (i.e IQ\<70); however those with an IQ in the 65-69 range will be included if the WRAT reading \>75.
• Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.
• Traumatic Brain Injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument.

Sponsors & Collaborators

• University of Calgary: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Related Links

• Faculty of medicine, University of Calgary

MeSH Terms

Conditions

Schizotypal Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Jean Addington, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: July 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 5, 2014

Record last verified: 2014-09