Cognitive Remediation in Early Phase Psychosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Stiftelsen Helse og Rehabilitering
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01546467
First received: January 12, 2012
Last updated: March 1, 2012
Last verified: March 2012

January 12, 2012
March 1, 2012
September 2009
December 2013   (final data collection date for primary outcome measure)
  • MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: Change in MCCB performance from baseline to 4 months and 9 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Cognitive Assessment Interview (CAI) [ Time Frame: Change in CAI scores from baseline to 4 months and 9 months ] [ Designated as safety issue: No ]
  • Social Functioning Scale (SFS) [ Time Frame: Change in SFS scores from baseline to 4 months and 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01546467 on ClinicalTrials.gov Archive Site
  • Calgary Depression Scale [ Time Frame: Change in CDS scores from baseline to 4 months and 9 months ] [ Designated as safety issue: No ]
  • Global Assessment of Function (GAF)- split version [ Time Frame: Change in GAF scores from baseline to 4 months and 9 months ] [ Designated as safety issue: No ]
  • event related fMRI [ Time Frame: Change in BOLD fMRI signal from baseline to 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cognitive Remediation in Early Phase Psychosis
Cognitive Remediation in Early Phase Psychosis

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Psychosis NOS
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
  • Experimental: Cognitive remediation
    30 hour computer based cognitive remediation integrated in participants current rehabilitation program (school, work, day program)
    Intervention: Behavioral: Cognitive remediation
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Traumatic brain injury
  • Neurological disorder as determined by medical history
  • IQ below 70
Both
18 Years to 40 Years
No
Contact: Torill Ueland, PhD +47 22118370 torill.ueland@medisin.uio.no
Contact: Ingrid Melle, PhD +47 22118469 ingrid.melle@medisin.uio.no
Norway
 
NCT01546467
2010/1788 (REK)
No
Oslo University Hospital
Oslo University Hospital
  • Stiftelsen Helse og Rehabilitering
  • South-Eastern Norway Regional Health Authority
Principal Investigator: Torill Ueland, PhD Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital
Oslo University Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP