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Cognitive Remediation in Early Phase Psychosis

This study is currently recruiting participants.
Verified March 2012 by Oslo University Hospital
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
History of Changes
  Purpose

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).


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Psychosis NOS
 Behavioral: Cognitive remediation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Remediation in Early Phase Psychosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: September 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546467

Contacts
Contact: Torill Ueland, PhD +47 22118370 torill.ueland@medisin.uio.no
Contact: Ingrid Melle, PhD +47 22118469 ingrid.melle@medisin.uio.no

Locations
Norway
Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital. Recruiting
Oslo, Norway, 0407
Contact: Torill Ueland, PhD     +47 22118370     torill.ueland@medisin.uio.no    
Sponsors and Collaborators
Oslo University Hospital
Stiftelsen Helse og Rehabilitering
South-Eastern Norway Regional Health Authority
Investigators
Principal Investigator: Torill Ueland, PhD Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01546467     History of Changes
Other Study ID Numbers: 2010/1788 (REK)
Study First Received: January 12, 2012
Last Updated: March 1, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority
Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
Schizophrenia
Schizoaffective disorder
Psychosis
 Early phase
Cognitive remediation
Functional outcome

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 16, 2013