NCT01206842

Brief Summary

People with schizophrenia show deficits in social cognition, the ability to process information about other people such as identifying their emotional expressions. Social cognition is associated with everyday life functioning and could therefore be an important treatment target. Several social cognitive training programs have been developed during the last years. Results indicate that social cognitive performance can be ameliorated through commonly used intervention techniques. However, it is less clear whether this improvement generalizes to everyday life. The purpose of this study is to investigate if a social cognitive training program (Training in Affect Recognition) improves performance on social cognitive and neuropsychological tests and leads to improved everyday life functioning in persons with schizophrenia. The study also aims at examining if an improvement is present three months after completion of the training intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 10, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

6.8 years

First QC Date

September 10, 2010

Last Update Submit

May 19, 2018

Conditions

Keywords

functional capacitytrainingneurocognition

Outcome Measures

Primary Outcomes (1)

  • Social cognitive tests

    PFA and MASC

    Within one week and within three months of completed training

Secondary Outcomes (2)

  • Functional capacity tests

    Within one week and within three months of completed training

  • Neuropsychological tests

    Within one week and within three months of completed training

Study Arms (2)

social cognition training

EXPERIMENTAL
Other: Training in Affect Recognition

treatment as usual

NO INTERVENTION

Interventions

A 12-session social cognitive training programming covering emotion perception and social perception administered in a group setting to up to four participants with schizophrenia at the time

social cognition training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-55
  • diagnosis of schizophrenia or schizoaffective disorder
  • IQ \> 69
  • sufficient mastery of Norwegian to undergo assessments

You may not qualify if:

  • history of head trauma
  • neurological/medical condition known to interfere with central nervous system
  • receiving outpatient care at time of recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Anja Vaskinn, PhD

    Oslo University Hospital, Psychosis Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 10, 2010

First Posted

September 22, 2010

Study Start

August 1, 2011

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations