NCT01781000

Brief Summary

The purpose of this study is to reveal the specific effects of computer-aided cognitive training on cerebral reorganization in schizophrenia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Dec 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

2.3 years

First QC Date

January 22, 2013

Last Update Submit

November 3, 2014

Conditions

Keywords

Cognitive TrainingNeuroplasticityMEGMATRICS

Outcome Measures

Primary Outcomes (1)

  • change from baseline at post-intervention (4-weeks) and 3-months in each to the primary outcome measures: neuropsychological test scores (MCCB), MEG alpha oscillations

    baseline, post-intervention (after 4 weeks), 3-months follow-up

Secondary Outcomes (1)

  • change from baseline in global functioning (GAF score) at 4 weeks and 3 months

    baseline, post-intervention, 3-months follow-up

Study Arms (3)

Auditiory verbal discrimination training

EXPERIMENTAL

Brain Fitness \& Brain Training- Posit Science

Behavioral: Brain Fitness & Brain Training- Posit Science

Facial affect discrimination training

EXPERIMENTAL

Behavioral: Facial Affect Training- FAT

Behavioral: Facial Affect Training- FAT

Treatment as usual

ACTIVE COMPARATOR

standard treatment/rehabilitation protocol of schizophrenia ward

Behavioral: Treatment as usual

Interventions

Computer aided cognitive program designed for intensive training of auditory perception, memory and attention

Auditiory verbal discrimination training

Computer-aided cognitive program designed for intensive training of facial affect discrimination, memory and attention

Facial affect discrimination training

standard treatment protocol of schizophrenia ward

Treatment as usual

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of schizophrenia and disorders with psychotic features
  • Intact auditory perception
  • Intact visual perception

You may not qualify if:

  • Mental retardation
  • Age over 60
  • Insufficient German language knowledge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Konstanz

Konstanz, Baden-Wurttemberg, 78464, Germany

Location

Related Publications (1)

  • Popova P, Popov TG, Wienbruch C, Carolus AM, Miller GA, Rockstroh BS. Changing facial affect recognition in schizophrenia: effects of training on brain dynamics. Neuroimage Clin. 2014 Sep 4;6:156-65. doi: 10.1016/j.nicl.2014.08.026. eCollection 2014.

    PMID: 25379427BACKGROUND

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Brigitte Rockstroh, Prof. Dr.

    University Konstanz

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 31, 2013

Study Start

December 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations