Skip to content

Cognitive Remediation in Early Phase Psychosis

Cognitive Remediation in Early Phase Psychosis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01546467
Enrollment
50
Registered
2012-03-07
Start date
2009-09-30
Completion date
2013-12-31
Last updated
2012-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis NOS, Schizoaffective Disorder, Schizophrenia

Keywords

Schizophrenia, Schizoaffective disorder, Psychosis, Early phase, Cognitive remediation, Functional outcome

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).

Interventions

BEHAVIORALCognitive 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

Sponsors

Stiftelsen Helse og Rehabilitering
CollaboratorOTHER
South-Eastern Norway Regional Health Authority
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Social Functioning Scale (SFS)Change in SFS scores from baseline to 4 months and 9 months
MATRICS Consensus Cognitive Battery (MCCB)Change in MCCB performance from baseline to 4 months and 9 monthsIncluded 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)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

Secondary

MeasureTime frameDescription
Calgary Depression ScaleChange in CDS scores from baseline to 4 months and 9 months
Global Assessment of Function (GAF)- split versionChange in GAF scores from baseline to 4 months and 9 months
event related fMRIChange in BOLD fMRI signal from baseline to 4 monthsEvent-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)Change in RSES scores from baseline to 4 months and 9 months

Countries

Norway

Contacts

Primary ContactTorill Ueland, PhD
torill.ueland@medisin.uio.no+47 22118370
Backup ContactIngrid Melle, PhD
ingrid.melle@medisin.uio.no+47 22118469

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026