Condition category
Mental and Behavioural Disorders
Date applied
22/12/2006
Date assigned
26/01/2007
Last edited
12/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Steffen Moritz

ORCID ID

Contact details

University Medical Center Hamburg-Eppendorf
Martinistrasse 52
Hamburg
20246
Germany

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

Sponsor information

Organisation

German Research Foundation (DFG)/Federal Ministry of Education and Research (BMBF) (Germany)

Sponsor details

Kennedyallee 40
Bonn
53175
Germany

Sponsor type

Government

Website

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

  1. 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.

Additional files

Editorial Notes