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Neurocognitive Training Integrated in OPUS Treatment Versus OPUS Treatment-as-usual (NEUROCOM)

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ClinicalTrials.gov Identifier: NCT00472862
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : April 15, 2015
Sponsor:
Information provided by:

Study Description
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 Design

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
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00472862


Locations
Denmark
Bispebjerg University Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Neurocom
Investigators
Study Chair: Merete Nordentoft, Professor Bispebjerg Hospital