Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DFG MO 969/6-1 & R03418/1-1
Study information
Scientific title
Acronym
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
Ethics approval
Local ethics committee in Hamburg, 13th November 2006 (ref: 2612).
Study design
Interventional randomised controlled observer-blinded parallel-group multicentre study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Schizophrenia
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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.
Overall trial start date
01/12/2006
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients diagnosed with schizophrenia spectrum disorder
2. Current or prior delusional symptoms
3. Informed consent
4. Clinical stability
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant 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
Recruitment start date
01/12/2006
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Germany
Trial participating centre
University Medical Center Hamburg-Eppendorf
Hamburg
20246
Germany
Funders
Funder type
Government
Funder name
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25103718
Publication citations
-
Results
Moritz S, Veckenstedt R, Andreou C, Bohn F, Hottenrott B, Leighton L, Köther U, Woodward TS, Treszl A, Menon M, Schneider BC, Pfueller U, Roesch-Ely D, Sustained and "Sleeper" Effects of Group Metacognitive Training for Schizophrenia: A Randomized Clinical Trial., JAMA Psychiatry, 2014, doi: 10.1001/jamapsychiatry.2014.1038.