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Metacognitive Training in Schizophrenia (MCT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01029067
First received: December 5, 2009
Last updated: July 22, 2011
Last verified: July 2011

December 5, 2009
July 22, 2011
September 2009
May 2012   (final data collection date for primary outcome measure)
delusion severity as assessed with the Positive and Negative Syndrome Scale (PANSS); sum of item scores p1, p5, p6 and g9 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029067 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Metacognitive Training in Schizophrenia
Metacognitive Training (MCT) Compared With Cognitive Remediation (CR) in Schizophrenia: a Randomized Controlled Study Over 4 Weeks

Over a period of 4 weeks, metacognitive training for schizophrenia patients (MCT), delivered both in a group and individually, is compared to cognitive remediation (CogPack training). Blind to treatment assignment, both groups are assessed before intervention and four weeks later with the Positive and Negative Symptoms Scale (PANSS), the Psychosis Rating Scales (PSYRATS) and cognitive tests. Delusion severity serves as the primary endpoint. It is assumed that MCT will improve delusion severity to a greater extent than CR in the course of 4 weeks taking medication into account.

Metacognitive training for schizophrenia patients (MCT) is a manualized group intervention that can be obtained cost-free online. MCT seeks to sharpen the awareness of schizophrenia spectrum patients on cognitive biases (e.g. jumping to conclusions) contributing to delusion formation and maintenance and conveys cognitive strategies to counter these. The present trial combines group MCT with an individualized cognitive-behavioral oriented approach entitled MCT+. Patients with schizophrenia are randomly allocated to either metacognitive treatment (MCT) or cognitive remediation (CogPack training). Blind to treatment assignment, both groups are assessed prior to intervention and four weeks later with the Positive and Negative Symptoms Scale (PANSS), the Psychosis Rating Scales (PSYRATS) and cognitive tasks. Delusion scores derived from the PANSS and PSYRATS serve as main outcome parameters. We also explore if MCT improves jumping to conclusions with a probabilistic reasoning task. To make results as generalizable as possible to a typical inpatient population, broad inclusion criteria are chosen. Patients are only excluded if age is < 18 and > 65 years and diagnoses do not meet criteria of a schizophrenia spectrum disorder.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Delusions
  • Schizophrenia
  • Behavioral: Metacognitive training
    Group (8 sessions) and individualized metacognitive training (9 sessions), delivered by psychologists versus cognitive remediation (8 sessions) delivered by either psychologists or psychology students at an advanced master level
    Other Name: n.a.
  • Behavioral: Cognitive Remediation
    Group (8 sessions) and individualized metacognitive training (9 sessions), delivered by psychologists versus cognitive remediation (8 sessions) delivered by either psychologists or psychology students at an advanced master level
  • Active Comparator: Cognitive Remediation
    Computerized cognitive remediation (CogPack training). A fixed series is administered, which covers a wide range of neuropsychological exercises involving memory, reasoning, selective attention and psychomotor speed. The difficulty level for each patient is adapted automatically depending on to the subject's performance on prior exercises. At the end of each session, the patient receives individual feedback on his or her performance. To match with group MCT, eight sessions are administered. Each session lasts approximately 45-60 minutes.
    Intervention: Behavioral: Cognitive Remediation
  • Experimental: Metacognitive Training
    The group metacognitive training program (MCT) is fully documented (Moritz, Woodward, & Metacognition Study Group, 2007; VanHam Campus Press) and can be obtained in more than 15 languages cost-free via the following link: www.uke.de/mkt. The group program is delivered to groups of 3-10 patients by trained psychologists addressing delusion-related metacognitive biases (e.g., jumping to conclusions). The eight modules are presented via a video projector using pdf-converted Power-Point slides. Each group session lasts approximately 45-60 minutes. Individualized MCT (MCT+) follows group sessions and accords to the general guidelines for cognitive-behavioral therapy. For each patient, 8 one-to-one sessions were carried in addition to one session relating to the medical history.
    Intervention: Behavioral: Metacognitive training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
July 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • schizophrenia spectrum disorder

Exclusion Criteria:

  • intellectual disability (IQ < 70)
  • unable to provide informed consent
  • hostility on PANSS > 4
  • suspiciousness on PANSS > 5
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01029067
MCT
No
Steffen Moritz, Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
Not Provided
Principal Investigator: Steffen Moritz, PhD Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP