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Cognitive Remediation in Early Phase Psychosis

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Psychosis NOS

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive remediation
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective disorder, Psychosis, Early phase, Cognitive remediation, Functional outcome

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive remediation

Wait list control group

Arm Description

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

Participant continues in treatment/rehabilitation program as usual until 9 month assessment when participant receives the same cognitive remediation program as the experimental group.

Outcomes

Primary Outcome Measures

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.
UCSD Performance Based Skilled Assessment Brief Version (UPSA-B)
Cognitive Assessment Interview (CAI)
Social Functioning Scale (SFS)

Secondary Outcome Measures

Calgary Depression Scale
Global Assessment of Function (GAF)- split version
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.
Rosenberg Self-Esteem Scale (RSES)

Full Information

First Posted
January 12, 2012
Last Updated
March 1, 2012
Sponsor
Oslo University Hospital
Collaborators
Stiftelsen Helse og Rehabilitering, South-Eastern Norway Regional Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01546467
Brief Title
Cognitive Remediation in Early Phase Psychosis
Official Title
Cognitive Remediation in Early Phase Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
Collaborators
Stiftelsen Helse og Rehabilitering, South-Eastern Norway Regional Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Psychosis NOS
Keywords
Schizophrenia, Schizoaffective disorder, Psychosis, Early phase, Cognitive remediation, Functional outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive remediation
Arm Type
Experimental
Arm Description
30 hour computer based cognitive remediation integrated in participants current rehabilitation program (school, work, day program)
Arm Title
Wait list control group
Arm Type
No Intervention
Arm Description
Participant continues in treatment/rehabilitation program as usual until 9 month assessment when participant receives the same cognitive remediation program as the experimental group.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation
Intervention Description
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
Primary Outcome Measure Information:
Title
MATRICS Consensus Cognitive Battery (MCCB)
Description
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.
Time Frame
Change in MCCB performance from baseline to 4 months and 9 months
Title
UCSD Performance Based Skilled Assessment Brief Version (UPSA-B)
Time Frame
Change in UPSA-B performance from baseline to 4 months and 9 months
Title
Cognitive Assessment Interview (CAI)
Time Frame
Change in CAI scores from baseline to 4 months and 9 months
Title
Social Functioning Scale (SFS)
Time Frame
Change in SFS scores from baseline to 4 months and 9 months
Secondary Outcome Measure Information:
Title
Calgary Depression Scale
Time Frame
Change in CDS scores from baseline to 4 months and 9 months
Title
Global Assessment of Function (GAF)- split version
Time Frame
Change in GAF scores from baseline to 4 months and 9 months
Title
event related fMRI
Description
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.
Time Frame
Change in BOLD fMRI signal from baseline to 4 months
Title
Rosenberg Self-Esteem Scale (RSES)
Time Frame
Change in RSES scores from baseline to 4 months and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Torill Ueland, PhD
Phone
+47 22118370
Email
torill.ueland@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid Melle, PhD
Phone
+47 22118469
Email
ingrid.melle@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torill Ueland, PhD
Organizational Affiliation
Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital.
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torill Ueland, PhD
Phone
+47 22118370
Email
torill.ueland@medisin.uio.no

12. IPD Sharing Statement

Learn more about this trial

Cognitive Remediation in Early Phase Psychosis

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