Metacognitive Training for Negative Symptoms

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSormland County Council, Sweden

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Metacognitive Training for Negative Symptoms (MCT)

    Other intervention

    See arm/group descriptions

  • Supportive Counselling

    Other intervention

    Se arm/group descriptions

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Metacognitive Training for Negative SymptomsExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
15 minutes
2

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.

Time frame
5 minutes
3

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.

Time frame
20 minutes

Secondary outcomes

1

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.

Time frame
5 minutes
2

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.

Time frame
5 minutes
3

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.

Time frame
5 minutes
4

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.

Time frame
10 minutes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Region SörmlandRecruiting Multiple LocationsSwedenSweden

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sormland County Council, Sweden

Lead sponsor

Uppsala County Council, Sweden

Collaborator

Västmanland County Council, Sweden

Collaborator