[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525843":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":53,"collaborators":55,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":9,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Sormland County Council, Sweden","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metacognitive Training for Negative Symptoms","EXPERIMENTAL","The original MCT intervention was adapted to negative symptoms by incorporating psychoeducation and strategies to target the cognitions suggested by the cognitive model (Beck et al., 2009) to be implicated in the development and\u002For maintenance of negative symptoms. Although some of the strategies have traditionally been used to target positive symptoms, it is assumed that the same reasoning styles lead to negative symptoms through the dysfunctional cognitions discussed previously (e.g., jumping to conclusions in regard to social rejection and a dysfunctional attribution style reinforcing social withdrawal). Metacognitive training for negative symptoms consists of eight sessions, delivered individually as there is evidence indicating that this approach may lead to stronger effect sizes than delivery in a group format (Liu et al., 2018). The developer of MCT (Professor Steffen Moritz) approved the modification.",[13],"Other: Metacognitive Training for Negative Symptoms (MCT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Supportive Counselling (8 sessions) will be used as a control. Participants enrolled in this condition can then get the intervention if they request this.",[19],"Other: Supportive Counselling",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Metacognitive Training for Negative Symptoms (MCT)","See arm\u002Fgroup descriptions",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Supportive Counselling","Se arm\u002Fgroup descriptions",[15],[31],{"name":32,"affiliation":33,"role":34},"Linda Swanson, Dr","Region Sörmland\u002F Uppsala University","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","0046-720 843 708","linda.swanson@regionsormland.se",{"name":41,"role":37,"phone":25,"phoneExt":25,"email":42},"Simon Cervenka, Prof","simon.cervenka@neuro.uu.se",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":25,"geoPoint":25,"contacts":50},"Region Sörmland","RECRUITING","Multiple Locations","Sweden","SE",[51],{"name":32,"role":37,"phone":52,"phoneExt":25,"email":39},"0046-72084 3708",{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[56,59],{"name":57,"class":58},"Uppsala County Council, Sweden","OTHER_GOV",{"name":60,"class":58},"Västmanland County Council, Sweden","100525843","metacognitive-training-for-negative-symptoms-100525843",false,"NCT06127004","Metacognitive Training for Negative Symptoms (MCT Minus)","Inclusion Criteria:\n\n* Over the age of 18\n* Clinical diagnosis of schizophrenia, delusional disorder or non-affective psychosis\n* Resident in Region Sörmland, Region Västmanland or Region Uppland\n\nExclusion Criteria:\n\n* Evidence of severe organic brain dysfunction\n* Learning disabilities\n* Difficulty with the Swedish language\n* Visual and\u002For hearing impairment\n* Being unable or unwilling to provide written informed consent","ALL","18 Years",{"count":70,"type":71},90,"ESTIMATED","INTERVENTIONAL",[74],"NA","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.\n\nThe 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.\n\nThe 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.",[77],"Negative Symptoms in Schizophrenia","2024-02-05",{"date":80,"type":81},"2024-02-06","ACTUAL",{"date":83,"type":81},"2024-01-01",{"date":85,"type":71},"2032-12",{"name":5,"class":6},1]