Metacognitive skill training for schizophrenic patients

ISRCTN	ISRCTN95205723
DOI	https://doi.org/10.1186/ISRCTN95205723
Protocol serial number	DFG MO 969/6-1 & R03418/1-1
Sponsor	German Research Foundation (DFG)/Federal Ministry of Education and Research (BMBF) (Germany)
Funders	Deutsche Forschungsgemeinschaft, Bundesministerium für Bildung und Forschung

Submission date: 22/12/2006
Registration date: 26/01/2007
Last edited: 07/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Steffen Moritz
Scientific

University Medical Center Hamburg-Eppendorf
Martinistrasse 52
Hamburg
20246
Germany

Study information

Primary study design	Interventional
Study design	Interventional randomised controlled observer-blinded parallel-group multicentre study.
Secondary study design	Randomised controlled trial
Scientific title	Metacognitive skill training for schizophrenic patients
Study objectives	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(s)	Local ethics committee in Hamburg, 13th November 2006 (ref: 2612).
Health condition(s) or problem(s) studied	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
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)
Key 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.
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	150
Key inclusion criteria	1. Patients diagnosed with schizophrenia spectrum disorder 2. Current or prior delusional symptoms 3. Informed consent 4. Clinical stability
Key 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
Date of first enrolment	01/12/2006
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Germany

Study participating centre

University Medical Center Hamburg-Eppendorf

Hamburg
20246
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2014		Yes	No
Results article	results	01/06/2018		Yes	No

Editorial Notes

07/01/2019: Publication reference added.