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
  Purpose

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.


Condition Intervention
Delusions
Schizophrenia
Behavioral: Metacognitive training
Behavioral: Cognitive Remediation

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: Metacognitive Training (MCT) Compared With Cognitive Remediation (CR) in Schizophrenia: a Randomized Controlled Study Over 4 Weeks

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • schizophrenia spectrum disorder

Exclusion Criteria:

  • intellectual disability (IQ < 70)
  • unable to provide informed consent
  • hostility on PANSS > 4
  • suspiciousness on PANSS > 5
  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: NCT01029067

Locations
Germany
University Medical Center Hamburg Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Steffen Moritz, PhD Universitätsklinikum Hamburg-Eppendorf
  More Information

Additional Information:
No publications provided

Responsible Party: Steffen Moritz, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01029067     History of Changes
Other Study ID Numbers: MCT
Study First Received: December 5, 2009
Last Updated: July 22, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
schizophrenia
delusion
paranoia
psychosis

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

ClinicalTrials.gov processed this record on October 21, 2014