SchizophreniaNCT01546467
Cognitive Remediation in Early Phase Psychosis
A study testing Cognitive remediation in people with Schizophrenia and Schizoaffective Disorder, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of the study is to investigate the effect of a 30 hour cognitive remediation program for young patients with early phase schizophrenia spectrum disorders on cognitive, clinical and functional outcome measures. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Psychosis NOS
- What is being tested?
- Cognitive remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2009to Dec 2013
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Early phase schizophrenia, schizoaffective disorder, psychosis NOS
- Less than 5 years since start of adequate treatment for psychotic disorder
- Age between 18-40
- Norwegian speaking (sufficiently to understand and complete assessments)
Who cannot join
- Traumatic brain injury
- Neurological disorder as determined by medical history
- IQ below 70
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital.
Oslo, 0407
Torill Ueland, PhD, +47 22118370, torill.ueland@medisin.uio.no
About this study
The purpose of the study is to investigate the effect of a 30 hour cognitive remediation program for young patients with early phase schizophrenia spectrum disorders on cognitive, clinical and functional outcome measures. The remediation program is integrated with whatever active rehabilitation the participant is currently attending (school, work, day program etc).
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychosis NOS
- Being tested
- Cognitive remediation
- Keywords
- Schizophrenia, Schizoaffective disorder, Psychosis, Early phase, Cognitive remediation, Functional outcome
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediationBehavioural
Cognitive remediation including feedback from neurocognitive assessment, psychoeducation about cognitive deficits, 30 hours of computer based drill and practise and strategy coaching based cognitive remediation, 1-3 collaborative meetings with cognitive specialist, participant, therapist and teacher, occupational therapist or other therapist (depending on participants rehabilitation situation) to enhance transfer of skills to daily functioning
| Study group | Role | What they receive |
|---|---|---|
| Cognitive remediation | Experimental | 30 hour computer based cognitive remediation integrated in participants current rehabilitation program (school, work, day program) Receives: Behavioral: Cognitive remediation |
| Wait list control group | No intervention | Participant continues in treatment/rehabilitation program as usual until 9 month assessment when participant receives the same cognitive remediation program as the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MATRICS Consensus Cognitive Battery (MCCB)
Included in the MCCB are measures of the following cognitive domains: Speed of Processing, Attention, Working memory, Verbal learning, Visual Learning, Reasoning and problem solving and Social Cognition. In addition the following tests are included: HVLT-R and BVMT-R delayed recall to measure memory, TMTB (Halstead Reitan) and Color Word Inteference Test (D-KEFS) to measure executive functioning), Digit span (WAIS-III)to measure working memory, Grooved Pegboard (Halstead Reitan) to measure motor function.
Measured: Change in MCCB performance from baseline to 4 months and 9 months
UCSD Performance Based Skilled Assessment Brief Version (UPSA-B)
Measured: Change in UPSA-B performance from baseline to 4 months and 9 months
Cognitive Assessment Interview (CAI)
Measured: Change in CAI scores from baseline to 4 months and 9 months
Social Functioning Scale (SFS)
Measured: Change in SFS scores from baseline to 4 months and 9 months
Secondary outcomes (4)
Calgary Depression Scale
Measured: Change in CDS scores from baseline to 4 months and 9 months
Global Assessment of Function (GAF)- split version
Measured: Change in GAF scores from baseline to 4 months and 9 months
event related fMRI
Event-related fMRI will be performed to measure neuronal activity during a spatial working memory tasks and an executive planning task. All fMRI data will be collected on Ullevål's 3 T General Electric Sigma HDx scanner.
Measured: Change in BOLD fMRI signal from baseline to 4 months
Rosenberg Self-Esteem Scale (RSES)
Measured: Change in RSES scores from baseline to 4 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startSep 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering, South-Eastern Norway Regional Health Authority
- Responsible party
- Sponsor
- Investigators
- Torill Ueland, PhD, Principal investigator, Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546467
- Sponsor's protocol ID
- 2010/1788 (REK)
- Status last verified
- Mar 2012
- First submitted
- 12 Jan 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation in Early Phase Psychosis
- ClinicalTrials.gov ID
- NCT01546467
- Acronym / sponsor ID
- 2010/1788 (REK)
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychosis NOS
- Keywords
- Schizophrenia, Schizoaffective disorder, Psychosis, Early phase, Cognitive remediation, Functional outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering, South-Eastern Norway Regional Health Authority
- Study start
- Sep 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 Mar 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.
The purpose of the study is to investigate the effect of a 30 hour cognitive remediation program for young patients with early phase schizophrenia spectrum disorders on cognitive, clinical and functional outcome measures. The remediation program is integrated with whatever active rehabilitation the participant is currently attending (school, work, day program etc).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive remediation | Experimental | Behavioral: Cognitive remediation30 hour computer based cognitive remediation integrated in participants current rehabilitation program (school, work, day program) |
| Wait list control group | No intervention | –Participant continues in treatment/rehabilitation program as usual until 9 month assessment when participant receives the same cognitive remediation program as the experimental group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Early phase schizophrenia, schizoaffective disorder, psychosis NOS
- Less than 5 years since start of adequate treatment for psychotic disorder
- Age between 18-40
- Norwegian speaking (sufficiently to understand and complete assessments)
Key exclusion criteria (3 listed)
- Traumatic brain injury
- Neurological disorder as determined by medical history
- IQ below 70
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 remediationCognitive remediation including feedback from neurocognitive assessment, psychoeducation about cognitive deficits, 30 hours of computer based drill and practise and strategy coaching based cognitive remediation, 1-3 collaborative meetings with cognitive specialist, participant, therapist and teacher, occupational therapist or other therapist (depending on participants rehabilitation situation) to enhance transfer of skills to daily functioning | Behavioural | Cognitive remediation |
Primary outcome
MATRICS Consensus Cognitive Battery (MCCB)
Time frame: Change in MCCB performance from baseline to 4 months and 9 months
Included in the MCCB are measures of the following cognitive domains: Speed of Processing, Attention, Working memory, Verbal learning, Visual Learning, Reasoning and problem solving and Social Cognition. In addition the following tests are included: HVLT-R and BVMT-R delayed recall to measure memory, TMTB (Halstead Reitan) and Color Word Inteference Test (D-KEFS) to measure executive functioning), Digit span (WAIS-III)to measure working memory, Grooved Pegboard (Halstead Reitan) to measure motor function.
UCSD Performance Based Skilled Assessment Brief Version (UPSA-B)
Time frame: Change in UPSA-B performance from baseline to 4 months and 9 months
Cognitive Assessment Interview (CAI)
Time frame: Change in CAI scores from baseline to 4 months and 9 months
Social Functioning Scale (SFS)
Time frame: Change in SFS scores from baseline to 4 months and 9 months
4 secondary outcomes
Calgary Depression Scale
Time frame: Change in CDS scores from baseline to 4 months and 9 months
Global Assessment of Function (GAF)- split version
Time frame: Change in GAF scores from baseline to 4 months and 9 months
event related fMRI
Time frame: Change in BOLD fMRI signal from baseline to 4 months
Rosenberg Self-Esteem Scale (RSES)
Time frame: Change in RSES scores from baseline to 4 months and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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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.
Torill Ueland, PhD principal investigator
Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation in people with Schizophrenia and Schizoaffective Disorder, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Torill Ueland, PhD (+47 22118370, torill.ueland@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MATRICS Consensus Cognitive Battery (MCCB) (time frame: Change in MCCB performance from baseline to 4 months and 9 months). The study lists 4 primary outcomes in all. 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 7 Mar 2012.