Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Region Sörmland
Coordinator of this site? Confirm its status
Multiple LocationsSwedenRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.