Metacognitive skill training for schizophrenic patients
| ISRCTN | ISRCTN95205723 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95205723 |
| Secondary identifying numbers | DFG MO 969/6-1 & R03418/1-1 |
- 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
Scientific
University Medical Center Hamburg-Eppendorf
Martinistrasse 52
Hamburg
20246
Germany
Study information
| Study design | Interventional randomised controlled observer-blinded parallel-group multicentre study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/12/2006 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
20246
Germany
Sponsor information
German Research Foundation (DFG)/Federal Ministry of Education and Research (BMBF) (Germany)
Government
Government
Kennedyallee 40
Bonn
53175
Germany
"ROR" |
https://ror.org/018mejw64 |
|---|
Funders
Funder type
Government
Deutsche Forschungsgemeinschaft
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
Bundesministerium für Bildung und Forschung
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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.
