Metacognitive Training in Schizophrenia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Delusions, Schizophrenia

Intervention / Treatment
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* Behavioral: Metacognitive training
* Behavioral: Cognitive Remediation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: schizophrenia spectrum disorder Exclusion Criteria: intellectual disability (IQ < 70) unable to provide informed consent hostility on PANSS > 4 suspiciousness on PANSS > 5

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Remediation<br>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<br>* 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<br>|
| Experimental: Metacognitive Training<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delusion severity as assessed with the Positive and Negative Syndrome Scale (PANSS); sum of item scores p1, p5, p6 and g9 |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, delusion, paranoia, psychosis