About this trial
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
This trial does not accept healthy volunteersQualifiers
Over the age of 18
Clinical diagnosis of schizophrenia, delusional disorder or non-affective psychosis
Resident in Region Sörmland, Region Västmanland or Region Uppland
Disqualifiers
Evidence of severe organic brain dysfunction
Learning disabilities
Difficulty with the Swedish language
Visual and/or hearing impairment
Trial design
Parallel
Treatments tested in this trial
Metacognitive Training for Negative Symptoms (MCT)
Other interventionSee arm/group descriptions
Supportive Counselling
Other interventionSe arm/group descriptions
Treatment groups
Trial outcomes
Primary outcomes
The Clinical Assessment Interview for Negative Symptoms (CAINS) (Forbes et al., 2011)
Clincial interview to assess negative symptoms. Minimum value is 0 = better outcome. Maximum value is 52 = worse outcome.
The Motivation and Pleasure Scale- Self-Report (MAP-SR) (Llerena et al., 2013)
Self-rated questionnaire to assess negative symptoms Minimum value is 0 = better outcome. Maximum value is 90 = worse outcome.
The Positive and Negative Syndrome Scale (PANSS) (Kay et al., 1987)
Clinical interview to assess negative symptoms (analysed with the five factor-model) Minimum value is 0 = better outcome. Maximum value is 210 = worse outcome.
Secondary outcomes
The Dysfunctional Attitudes Scale (DAS) (Weissman & Beck, 1978)
Self-rated questionnaire to assess defeatist attitudes Minimum value is 100 = better outcome. Maximum value is 700 = worse outcome.
The Reflective Functioning Questionnaire (RFQ-8) (Fonagy et al., 2016)
Self-rated questionnaire to assess metacognitive ability Minimum value is 8 = worse outcome. Maximum value is 24 = better outcome.
The Internalized Stigma of Mental Illness Scale-9 (ISMI-9) (Hammer & Toland, 2017)
Self-rated questionnaire to assess stigma Minimum value is 1 = better outcome. Maximum value is 4 = worse outcome.
The Calgary Depression Scale for Schizophrenia (CDSS) (Addington, Addington, & Schissel, 1990)
Clinical interview to assess depressive symptoms in schizophrenia Minimum value is 0 = better outcome. Maximum value is 36 = worse outcome.
Locations
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Sponsors and contacts
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Sormland County Council, Sweden
Lead sponsor
Uppsala County Council, Sweden
Collaborator
Västmanland County Council, Sweden
Collaborator