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Neurocognitive Training Integrated in OPUS Treatment Versus OPUS Treatment-as-usual

NCT00472862 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2015-04-15

No results posted yet for this study

Summary

The study examines the effect of cognitive training on cognitive functioning and everyday competencies of patients with schizophrenia.

120 patients are expected to be included in this randomized controlled trial running at two sites in Denmark starting January 2007 The effect of a 16-week, manualized program of cognitive training integrated in a comprehensive psychosocial treatment (OPUS) for first-episode schizophrenia patients is compared with the effect of standard treatment (OPUS). A six month follow-up assessment is conducted to investigate a possible long-term learning effect of cognitive training.

Blinded assessments include the MATRICS Consensus Cognitive Battery and a co-primary outcome measure of cognitive improvement: A translated version of the UCSD Performance-based Skills Assessment (UPSA) adjusted to a Danish context.

The cognitive training consists of four modules focusing on the domain of attention, executive functioning, learning and memory. Module 1 and 2 are based on computer-assisted training tasks, and the following modules focus on more practical everyday tasks and calendar training. Cognitive training takes place twice a week and every other week the patient and trainer engage in a dialogue on the patient's cognitive difficulties, motivational goals and his/her progress in competence level.

The use of errorless learning principles, scaffolding and attentional externalisation aims at improving the patients' performance on cognitive and everyday tasks by learning to apply compensation techniques as well as limiting dysfunctional uses of available cognitive ressources (i.e. excessive self-focus, rumination).

The study will provide MATRICS Consensus Cognitive Battery results from a relatively large Danish sample of first-episode schizophrenia and contribute with valuable normative data on the UPSA.

It is hypothesized that cognitive training integrated in OPUS treatment enhances both cognitive and everyday competence of patients more than OPUS treatment alone. Expectations are that cognitive training will demonstrate a small to moderate effect on cognitive functioning and a moderate effect on everyday functioning as measured with the UPSA. Moreover, patients allocated to cognitive training are expected to show an improvement in self-esteem.

Conditions

Interventions

BEHAVIORAL

Cognitive training

Cognitive training for 16 weeks integrated in OPUS psychosocial treatment

Sponsors & Collaborators

  • Neurocom

    lead INDUSTRY

Principal Investigators

  • Merete Nordentoft, Professor · Bispebjerg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00472862 on ClinicalTrials.gov