Prodromal SchizophreniaNCT01619319
Effects of Cognitive Remediation on Cognition in Young People at Clinical High Risk of Psychosis
A study testing Cognitive Remediation Therapy and computer games in people with Prodromal Schizophrenia, run by University of Calgary.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Prodromal Schizophrenia
- What is being tested?
- Cognitive Remediation Therapy and computer games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
- 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.
- -
About this study
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.
Read the 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).
- Conditions
- Prodromal Schizophrenia
- Being tested
- Cognitive Remediation Therapy, computer games
- Keywords
- schizophrenia prodrome, clinical high risk of psychosis
- Medical subject headings
- Schizotypal Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation TherapyOther
Also called Brain Fitness Program
auditory computer games designed to improve the speed at which people react when they hear something and at which they process that information.
computer gamesOther
Also called Hoyle Puzzle and Board Games
computer games that that consist of word puzzles
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation Therapy | Experimental | A computerised cognitive remediation intervention called the Brain Fitness program is compared against a placebo intervention consisting of computer games Receives: Other: Cognitive Remediation Therapy |
| computer games | Active comparator | computer games Receives: Other: computer games |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
GFS= Global Functioning Scale (GFS): Social and Role
Functioning scales will be used to asses if changes in cognitive function are associated with changes in social and role functioning.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJul 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prodromal SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Principal investigator, Jean Addington, M.D., University of Calgary
- Investigators
- Jean Addington, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619319
- Sponsor's protocol ID
- Cognitive Remediation in CHR
- Status last verified
- Sep 2014
- First submitted
- 12 Jun 2012
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Remediation on Cognition in Young People at Clinical High Risk of Psychosis
- ClinicalTrials.gov ID
- NCT01619319
- Acronym / sponsor ID
- Cognitive Remediation in CHR
- Conditions
- Prodromal Schizophrenia
- Keywords
- schizophrenia prodrome, clinical high risk of psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Jul 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation Therapy | Experimental | Other: Cognitive Remediation TherapyA computerised cognitive remediation intervention called the Brain Fitness program is compared against a placebo intervention consisting of computer games |
| computer games | Active comparator | Other: computer gamescomputer games |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
- -
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Remediation TherapyAlso: Brain Fitness Programauditory computer games designed to improve the speed at which people react when they hear something and at which they process that information. | Other | Cognitive Remediation Therapy |
| computer gamesAlso: Hoyle Puzzle and Board Gamescomputer games that that consist of word puzzles | Other | computer games |
Primary outcome
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Time frame: 12 months
MATRICS will be used to assess changes in cognition at the end of treatment and 12 months post baseline.
1 secondary outcome
GFS= Global Functioning Scale (GFS): Social and Role
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
- Faculty of medicine, University of CalgaryLink provided by the sponsor.
Related trials for Prodromal Schizophrenia
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Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis
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Online Intervention To Improve Motivation
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Recruiting
Accelerated Neuromodulation Therapy and Neurocomputational Biomarkers in Individuals at Clinical High Risk for Psychosis
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Active, not recruiting
EPI-MINN: Targeting Cognition and Motivation - National
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Addington, PhD principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation Therapy and computer games in people with Prodromal Schizophrenia, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2014.