Neurocognitive Training Integrated in OPUS Treatment Versus OPUS Treatment-as-Usual (NEUROCOM)
Recruitment status was Active, not recruiting
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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 |
- 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 |
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 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 May 16, 2013