NCT06127004 Metacognitive Training for Negative Symptoms
| NCT ID | NCT06127004 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sormland County Council, Sweden |
| Condition | Negative Symptoms in Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-01-01 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Linda Swanson, Dr
PRINCIPAL INVESTIGATOR
Region Sörmland/ Uppsala University
Frequently Asked Questions
Who can join the NCT06127004 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Negative Symptoms in Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06127004 currently recruiting?
Yes, NCT06127004 is actively recruiting participants. Contact the research team at linda.swanson@regionsormland.se for enrollment information.
Where is the NCT06127004 trial being conducted?
This trial is being conducted at Multiple Locations, Sweden.
Who is sponsoring the NCT06127004 clinical trial?
NCT06127004 is sponsored by Sormland County Council, Sweden. The principal investigator is Linda Swanson, Dr at Region Sörmland/ Uppsala University. The trial plans to enroll 90 participants.
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