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Clinical Trials in Sweden / NCT06127004
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Metacognitive Training for Negative Symptoms

NCT06127004 · tracked via the Priya Life Science Sweden tracker
Sponsor
Sormland County Council, Sweden
Phase
Not applicable
Started
2024-01-01
Last updated
2024-02-06

Condition(s) studied

Negative Symptoms in Schizophrenia

Investigational drug(s) / intervention(s)

Metacognitive Training for Negative Symptoms (MCT)Supportive Counselling

Metacognitive Training for Negative Symptoms (MCT): See arm/group descriptions

Supportive Counselling: Se arm/group descriptions

Study summary

There is a clear rationale for developing interventions targeting negative symptoms of schizophrenia as these are a stronger indicator of current and future functioning than positive symptoms and because they respond poorly to medication and existing psychological interventions. This is reflected in the NIMH-MATRICS consensus statement that emphasised that persistent negative symptoms represent an unmet therapeutic need for patients suffering from schizophrenia.

The purpose of this study is to evaluate, in a scientific manner, the intervention developed by Swanson et al. 2021: Metacognitive Training (MCT) Minus. The MCT was adapted to target negative symptoms in psychotic disorders (e.g. schizophrenia, schizoaffective or non-affective functional psychosis) as the original version of the intervention focused exclusively on positive symptoms. The specific aim is to study whether MCT Minus is a promising treatment for the intended population in terms of reductions in negative symptoms, severity of defeatist attitudes, internalised stigma, and depression as well as improvements in reflective ability and overall functioning.

The research will add to existing research by identifying and measuring potential mechanisms of change for negative symptoms (i.e., defeatist attitudes, reflective functioning, stigma and depression). It will also add to the existing evidence base by measuring whether the cognitive biases addressed in MCT lead to changes in the wider conceptualisation of metacognition used elsewhere and whether the promising results seen in the feasibility study of MCT Minus can be replicated in a randomised controlled trial (RCT) with a control group and a blinded assessor. The researchers also hope to replicate the findings of a previous study, where MCT was found to be related to the modulation of default-mode network (DMN) homogeneity in schizophrenia, an area thought to be involved in self- and other-reflectivity.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Over the age of 18 * Clinical diagnosis of schizophrenia, delusional disorder or non-affective psychosis * Resident in Region Sörmland, Region Västmanland or Region Uppland Exclusion Criteria: * Evidence of severe organic brain dysfunction * Learning disabilities * Difficulty with the Swedish language * Visual and/or hearing impairment * Being unable or unwilling to provide written informed consent

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Region Sörmland Multiple Locations Sweden Recruiting

More Sormland County Council, Sweden trials in Sweden

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06127004 on ClinicalTrials.gov ↗ ← All trials in Sweden