NCT06127004Recruiting
Metacognitive Training for Negative Symptoms
Metacognitive Training for Negative Symptoms (MCT Minus)
Source: ClinicalTrials.gov · Last updated 6 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 22 Jul 2023
- Start date
- 1 Jan 2024
- Primary completion date
- Dec 2030
- Lead sponsor
- Sormland County Council, Sweden
- Diseases
- Schizophrenia
- NCT number
- NCT06127004
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 1 Jan 2024 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Visual and/or hearing impairment
Other
- Evidence of severe organic brain dysfunction
- Learning disabilities
- Difficulty with the Swedish language
- Being unable or unwilling to provide written informed consent
Who the study is looking for
- Over the age of 18
- Clinical diagnosis of schizophrenia, delusional disorder or non-affective psychosis
- Resident in Region Sörmland, Region Västmanland or Region Uppland
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Sörmland Coordinator of this site? Confirm its status | Multiple Locations | Sweden | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.