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Trial record 1 of 1 for:    NCT00472862
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Neurocognitive Training Integrated in OPUS Treatment Versus OPUS Treatment-as-usual (NEUROCOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00472862
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : April 15, 2015
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Cognitive training Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NEUROCOM: Cognitive Training for Patients With First Episode Schizophrenia
Study Start Date : January 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 2
Cognitive training
Behavioral: Cognitive training
Cognitive training for 16 weeks integrated in OPUS psychosocial treatment

Active Comparator: 1
OPUS psychosocial treatment alone
Behavioral: Cognitive training
Cognitive training for 16 weeks integrated in OPUS psychosocial treatment

Primary Outcome Measures :
  1. USCD Performance-Based Skills Assessment [ Time Frame: 2009 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 18-35 years,
  • First-episode schizophrenia og schizotypal disorder in ICD-10,
  • Post-acute phase of illness,
  • Sufficient comprehension of Danish,
  • Written informed consent

Exclusion Criteria:

  • Rejection of participation,
  • Organic disorder,
  • Misuse of psychoactive drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00472862

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Bispebjerg University Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
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Study Chair: Merete Nordentoft, Professor Bispebjerg Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Psychiatric Center Bispebjerg Identifier: NCT00472862    
Other Study ID Numbers: 333077
Danish Research Counsil
Bristol-Myers Squibbs
Sygekassernes Helsefond
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders