Clinical trial NCT01619319: Effects of Cognitive Remediation on Cognition in Young People at Clinical High Risk of Psychosis
Official title: Effects of Cognitive Remediation on Cognition in Young People at Clinical High Risk of Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prodromal Schizophrenia
Keywords: schizophrenia prodrome
clinical high risk of psychosis
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2012-06-14
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Participants were randomised to either the BFP or a control treatment consisting of commercial computer games (CG). Participants were not blind to group allocation but all cognitive and symptom raters were. The 40 hours of BFP or computer game activity was expected to occur 4 days a week, for an hour each day, over a period of 10-12 weeks. The primary outcome was cognitive function assessed using the MATRICS consensus cognitive battery MCCB) (Nuechterlein and others 2008). The secondary outcome was social and role functioning assessed with Global Functioning: Social and Role scales. All clinical and cognitive assessments using symptom, functioning and cognitive measures were performed at baseline, post-treatment (at 3 months) and at 9-month follow-up (i.e. 9 months post baseline or 6 months after post-treatment assessment).

Eligibility 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.

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Primary outcomes:
measure: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
timeFrame: 12 months
Secondary outcomes:
measure: GFS= Global Functioning Scale (GFS): Social and Role
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Jean Addington, PhD
role: PRINCIPAL_INVESTIGATOR
References: