NCT01546467

Brief 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. The remediation program is integrated with whatever active rehabilitation the participant is currently attending (school, work, day program etc).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

4.3 years

First QC Date

January 12, 2012

Last Update Submit

March 1, 2012

Conditions

SchizophreniaSchizoaffective DisorderPsychosis NOS

Keywords

SchizophreniaSchizoaffective disorderPsychosisEarly phaseCognitive remediationFunctional outcome

Outcome Measures

Primary Outcomes (4)

  • 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.

    Change in MCCB performance from baseline to 4 months and 9 months

  • UCSD Performance Based Skilled Assessment Brief Version (UPSA-B)

    Change in UPSA-B performance from baseline to 4 months and 9 months

  • Cognitive Assessment Interview (CAI)

    Change in CAI scores from baseline to 4 months and 9 months

  • Social Functioning Scale (SFS)

    Change in SFS scores from baseline to 4 months and 9 months

Secondary Outcomes (4)

  • Calgary Depression Scale

    Change in CDS scores from baseline to 4 months and 9 months

  • Global Assessment of Function (GAF)- split version

    Change in GAF scores from baseline to 4 months and 9 months

  • event related fMRI

    Change in BOLD fMRI signal from baseline to 4 months

  • Rosenberg Self-Esteem Scale (RSES)

    Change in RSES scores from baseline to 4 months and 9 months

Study Arms (2)

Cognitive remediation

EXPERIMENTAL

30 hour computer based cognitive remediation integrated in participants current rehabilitation program (school, work, day program)

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.

Interventions

Cognitive remediationBEHAVIORAL

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

Cognitive remediation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Traumatic brain injury
  • Neurological disorder as determined by medical history
  • IQ below 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital.

Oslo, 0407, Norway

RECRUITING

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMental Disorders

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Torill Ueland, PhD

    Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Torill Ueland, PhD

CONTACT

+47 22118370torill.ueland@medisin.uio.no

Ingrid Melle, PhD

CONTACT

+47 22118469ingrid.melle@medisin.uio.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

March 7, 2012

Study Start

September 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

NO(1)