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

This study is currently recruiting participants.
Verified June 2012 by University of Calgary
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Jean Addington, M.D., University of Calgary
ClinicalTrials.gov Identifier:
NCT01619319
First received: June 12, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Prodromal Schizophrenia
Other: Cognitive Remediation Treatment
Other: Cognitive Remediation Therapy
Other: computer games

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effects of Cognitive Remediation on Cognition in Young People at Clinical High Risk of Psychosis

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    MATRICS will be used to assess changes in cognition at the end of treatment and 12 months post baseline.


Secondary Outcome Measures:
  • GFS= Global Functioning Scale (GFS): Social and Role [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Functioning scales will be used to asses if changes in cognitive function are associated with changes in social and role functioning.


Estimated Enrollment: 36
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Remediation Treatment
A computerised cognitive remediation intervention called the Brain Fitness program is compared against a placebo intervention consisting of computer games
Other: Cognitive Remediation Treatment
A computerised cognitive remediation treatment called the Brain Fitness Program involves auditory training exercises. It is designed to improve inefficient auditory processing of information in the brain by re-establishing neuroplastic changes that enable more efficient interpretation of semantic and emotional aspect of speech. That is, efficient auditory processing is pivotal for the successful interpretation and recovery of verbal information. It is delivered over 40 sessions: 4 sessions per week, 1 hour per session.
Other Name: The Brain Fitness Program (BFP)
Other: Cognitive Remediation Therapy
auditory computer games designed to improve the speed at which people react when they hear something and at which they process that information.
Other Name: Brain Fitness Program
Active Comparator: computer games
computer games
Other: computer games
computer games that that consist of word puzzles
Other Name: Hoyle Puzzle and Board Games

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1.

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

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Exclusion Criteria:

  1. Meet criteria for current or lifetime Axis I psychotic disorder, including affective psychoses and psychosis NOS.
  2. No current treatment with antipsychotic medication unless it can be clearly demonstrated that the diagnostic prodromal criteria were present prior to the antipsychotic.
  3. 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.
  4. Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.
  5. Traumatic Brain Injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument.
  6. The diagnostic prodromal symptoms are clearly caused by an Axis 1 disorder, including substance use disorders, in the judgment of the evaluating clinician. Other non-psychotic DSM-IV disorders will not be exclusionary (e.g. substance abuse disorder, major depression, anxiety disorders, Axis II Disorders), as long as the disorder does not account for the diagnosis of prodromal symptoms.

    -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619319

Locations
Canada, Alberta
University of Calgary, Department of Psychaitry Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Nicole McKenzie, MSc    403 210 6026    mckenzin@ucalgary.ca   
Contact: Jean Addington, PhD    403 210 6379    jmadding@ucalgray.ca   
Principal Investigator: Jean Addington, PhD         
Sponsors and Collaborators
University of Calgary
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Jean Addington, PhD University of Calgary
  More Information

Additional Information:
No publications provided

Responsible Party: Jean Addington, M.D., Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT01619319     History of Changes
Other Study ID Numbers: Cognitive Remediation in CHR
Study First Received: June 12, 2012
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Calgary:
schizophrenia prodrome
clinical high risk of psychosis

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

ClinicalTrials.gov processed this record on April 17, 2014