Metacognitive Training in Schizophrenia

NCT ID: NCT01029067

Last Updated: 2015-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-12-31

Brief Summary

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.

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.

Conditions

Delusions; Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Remediation

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Metacognitive training

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steffen Moritz, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

University Medical Center Hamburg Eppendorf

Hamburg, City state of Hamburg, Germany

Countries

Germany

Related Links

http://www.uke.de/mkt

link to metacognitive training site, where training material can be downloaded cost-free

Other Identifiers

MCT

Identifier Type: -

Identifier Source: org_study_id