Cognitive Remediation in Early Phase Psychosis

Schizophrenia Clinical Trial

Official title:

Cognitive Remediation in Early Phase Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01546467
• Other study ID #: 2010/1788 (REK)
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2012
• Last updated: March 1, 2012
• Start date: September 2009
• Est. completion date: December 2013

Study information

• Verified date: March 2012
• Source: Oslo University Hospital
• Contact: Torill Ueland, PhD
• Phone: +47 22118370
• Email: torill.ueland[@]medisin.uio.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Data Protection AuthorityNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis NOS
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Norway	Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital.	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	South-Eastern Norway Regional Health Authority, Stiftelsen Helse og Rehabilitering

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	UCSD Performance Based Skilled Assessment Brief Version (UPSA-B)		Change in UPSA-B performance from baseline to 4 months and 9 months	No
Primary	Cognitive Assessment Interview (CAI)		Change in CAI scores from baseline to 4 months and 9 months	No
Primary	Social Functioning Scale (SFS)		Change in SFS scores from baseline to 4 months and 9 months	No
Secondary	Calgary Depression Scale		Change in CDS scores from baseline to 4 months and 9 months	No
Secondary	Global Assessment of Function (GAF)- split version		Change in GAF scores from baseline to 4 months and 9 months	No
Secondary	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	No
Secondary	Rosenberg Self-Esteem Scale (RSES)		Change in RSES scores from baseline to 4 months and 9 months	No