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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Neurocom.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Neurocom
ClinicalTrials.gov Identifier:
NCT00472862
First received: May 11, 2007
Last updated: June 17, 2009
Last verified: June 2009
  Purpose

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 Intervention Phase
Schizophrenia
Behavioral: Cognitive training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NEUROCOM: Cognitive Training for Patients With First Episode Schizophrenia

Resource links provided by NLM:


Further study details as provided by Neurocom:

Primary Outcome Measures:
  • USCD Performance-Based Skills Assessment [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2007
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472862

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

No publications provided by Neurocom

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Psychiatric Center Bispebjerg
ClinicalTrials.gov Identifier: NCT00472862     History of Changes
Other Study ID Numbers: 333077, Danish Research Counsil, Bristol-Myers Squibbs, Sygekassernes Helsefond, Lundbeckfonden
Study First Received: May 11, 2007
Last Updated: June 17, 2009
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014