Cognitive Remediation in Early Phase Psychosis
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|ClinicalTrials.gov Identifier: NCT01546467|
Recruitment Status : Unknown
Verified March 2012 by Oslo University Hospital.
Recruitment status was: Recruiting
First Posted : March 7, 2012
Last Update Posted : March 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Psychosis NOS||Behavioral: Cognitive remediation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive Remediation in Early Phase Psychosis|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Experimental: Cognitive remediation
30 hour computer based cognitive remediation integrated in participants current rehabilitation program (school, work, day program)
Behavioral: Cognitive remediation
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
No Intervention: Wait list control group
Participant continues in treatment/rehabilitation program as usual until 9 month assessment when participant receives the same cognitive remediation program as the experimental group.
- 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 ]
- 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 ]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.
- Rosenberg Self-Esteem Scale (RSES) [ Time Frame: Change in RSES scores from baseline to 4 months and 9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546467
|Contact: Torill Ueland, PhD||+47 firstname.lastname@example.org|
|Contact: Ingrid Melle, PhD||+47 email@example.com|
|Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital.||Recruiting|
|Oslo, Norway, 0407|
|Contact: Torill Ueland, PhD +47 22118370 firstname.lastname@example.org|
|Principal Investigator:||Torill Ueland, PhD||Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital|