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).

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Schizoaffective Disorder; Psychosis NOS
• Intervention / Treatment: Behavioral: Cognitive remediation

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Torill Ueland, PhD; Phone Number: +47 22118370; Email: torill.ueland@medisin.uio.no
• Study Contact Backup: Name: Ingrid Melle, PhD; Phone Number: +47 22118469; Email: ingrid.melle@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0407
    • Recruiting
    • Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital.
    • Contact: Torill Ueland, PhD; Phone Number: +47 22118370; Email: torill.ueland@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: South-Eastern Norway Regional Health Authority; Stiftelsen Helse og Rehabilitering
• Investigators: Principal Investigator: Torill Ueland, PhD, Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (ESTIMATE): March 7, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 7, 2012
• Last Update Submitted That Met QC Criteria: March 1, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Schizophrenia; Psychosis; Early phase; Cognitive remediation; Schizoaffective disorder; Functional outcome
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 2010/1788 (REK)