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Metacognitive skill training for schizophrenic patients
ISRCTN ISRCTN95205723
DOI 10.1186/ISRCTN95205723
ClinicalTrials.gov identifier
EudraCT number
Public title Metacognitive skill training for schizophrenic patients
Scientific title
Acronym N/A
Serial number at source DFG MO 969/6-1 & R03418/1-1
Study hypothesis 1. Primary objective: assessment of schizophrenic positive symptoms before and after intervention (hypothesis: accelerated symptom decline under experimental intervention)
2. Secondary objective: assessment of metacognitive deficits assumed to underlie delusion formation in schizophrenia before and after intervention (hypothesis: accelerated amelioration of metacognitive deficits under experimental intervention)

Please note that as of 01/11/2012, the target number of participants was updated from 300 to 150, due to an error in the original application
Lay summary Not provided at time of registration
Ethics approval Local ethics committee in Hamburg, 13th November 2006 (ref: 2612).
Study design Interventional randomised controlled observer-blinded parallel-group multicentre study.
Countries of recruitment Germany
Disease/condition/study domain Schizophrenia
Participants - inclusion criteria 1. Patients diagnosed with schizophrenia spectrum disorder
2. Current or prior delusional symptoms
3. Informed consent
4. Clinical stability
Participants - exclusion criteria 1. Age beyond 65
2. Severe brain damage
3. Intelligence Quotient (IQ) less than 70
4. More than or equal to five for ratings on hostility and non-cooperativeness and more than or equal to six on suspiciousness according to Positive And Negative Symptoms Scale (PANSS) interview
5. Incapacity to give informed consent
Anticipated start date 01/12/2006
Anticipated end date 31/12/2009
Status of trial Completed
Patient information material
Target number of participants 150
Interventions Experimental intervention:
MetaCognitive skill Training (MCT) focusing on delusion-relevant metacognitive biases in schizophrenia.

Control intervention:
Cognitive remediation (computer-supported cognitive training program [COGPACK]).

Duration of intervention per patient: four weeks; sessions are scheduled twice weekly.
Primary outcome measure(s) Current primary outcome measure as of 01/11/2012:
A delusion score derived from the Positive and Negative Syndrome Scale (PANSS): sum score of items p1 (delusions), p5 (grandiosity) and p6 (suspiciousness)

Previous primary outcome measures until 01/11/2012:
1. Decline on PANSS positive subscale from T1 (baseline) to T2 (four weeks/assessment immediately after the end of intervention)
2. Conventional algorithm (i.e., sum of PANSS positive items one to seven)
Secondary outcome measure(s) 1. Improvement of dysfunctional metacognitive biases (i.e., self-serving bias, jumping to conclusions bias, incorrigibility, over-confidence in errors, enhanced need for closure)
2. Subsequent to intervention represents secondary outcome parameter (i.e., difference T1-T2)

Secondary analyses will include follow-up.
Sources of funding German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG)/Federal Ministry of Education and Research Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (Germany)
Trial website
Publications 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25103718
Contact name Dr  Steffen  Moritz
  Address University Medical Center Hamburg-Eppendorf
Martinistrasse 52
  City/town Hamburg
  Zip/Postcode 20246
  Country Germany
Sponsor German Research Foundation (DFG)/Federal Ministry of Education and Research (BMBF) (Germany)
  Address Kennedyallee 40
  City/town Bonn
  Zip/Postcode 53175
  Country Germany
Date applied 22/12/2006
Last edited 12/08/2014
Date ISRCTN assigned 26/01/2007
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