F20
Conditions
Interventions
Group 1: Individualized Metacognitive Therapy (MCT+) for psychosis is a manualized treatment for therapy in a one-on-one setting (www.uke.de/mkt_plus). It includes the following 11 therapy units:
Unit
Sponsors
Universitätsklinikum Hamburg-EppendorfKlinik und Poliklinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) schizophrenia or schizoaffective disorder (confirmed by MINI) 2) informed consent
Exclusion criteria
Exclusion criteria: 1) intelligence: IQ < 70 (Wortschatztest) 2) PANSS scores = 5 for hostility and non-cooperativeness (G8, P7); 3) high suicide risk 4) current alcohol or substance dependence, excluding tobacco (abstinence < 6 months; alcohol and substance abuse are allowed) 5) any form of documented or suspected major neurological or general medical condition that might be responsible for the psychotic manifestations 6) participation in MCT+ in the past 12 months 7) insufficient German language abilities 8) insufficient capability for assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The PSYRATS is a commonly used semi-structured interview that measures quantitative and qualitative aspects of delusions and hallucinations, including preoccupation, conviction and distress. The difference in PSYRATS score for both delusions and hallucinations from T0 to T2 serves as the primary outcome parameter. The validity of the PSYRATS has been demonstrated in chronically psychotic patients and it has been shown to have good psychometric properties. Three outcome time points: Baseline, post-assessment (6 weeks after baseline) and follow-up (6 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| The Positive and Negative Symptoms Scale (PANSS) is a 30-item scale that assesses positive, negative, and general psychopathology based on a semi-structured interview. Additional secondary endpoint outcomes include the following: The Fish Task is a computerized variant of the classical Beads Task, which measures jumping to conclusions. The Personal and Social Performance Scale is a scale that evaluates social functioning in individuals with schizophrenia. The Short Form-12 (SF-12) assesses the impact of physical and mental factors on quality of life. The Calgary Depression Rating Scale (CDSS) will be used to measure depressive symptomatology in individuals with schizophrenia. The Negative Symptom Assessment – 4 (NSA-4) is a rating scale to assess negative symptoms. The Frith-Happe Animations tap Theory of Mind deficits while the Beck Cognitive Insight Scale (BCIS) measures self-reported ability to distance oneself from and reflect upon subjective cognitive biases. The WHO Quality of Life scale (WHOQOL-BREF) will be used to assess participants’ quality of life. The Obsessive-Compulsive Inventory – Revised (OCI-R) measures distress associated with obsessive and compulsive symptoms. The Rosenberg Self-Esteem Scale will be used to measure global self-esteem. The Patient Health Questionnaire (9-item) is a screening measure of the severity of depressive symptoms. Additionally, the following neuropsychological measures will be administered: Trail Making Tests A and B (mental flexibility, set-shifting), Test d2 (selective attention), Logical Memory from the Rivermead Behavioural Memory Test (short- and long-term memory) and the German Wortschatztest (WST; premorbid intelligence). Three outcome time points: Baseline, post-assessment (6 weeks after baseline) and follow-up (6 months). Changes in the scores on the aforementioned measures serve as the secondary outcomes. | — |
Countries
Germany
Contacts
Public ContactSteffen Moritz
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed