|- candidate number||1600|
|- NTR Number||NTR443|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||13-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Prodromal symptoms and early intervention to prevent a relapse.|
|- Scientific Title||Relapse prevention in schizophrenia.|
|- hypothesis||Could early treatment of prodromal symptoms prevent or postpone a psychotic relapse in schizophrenia?|
|- Healt Condition(s) or Problem(s) studied||Schizophrenia, Schizophreniform disorder|
|- Inclusion criteria||1. ICD-10 diagnosis of schizophrenia (F20) or schizoaffective disorder (F25);
2. A remitted state established by no more than one score of 4 on the positive scale of the PANSS (28);
3. Necessary skills in Dutch language to underwent a training in Dutch.
|- Exclusion criteria||Substance abuse.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-1997|
|- planned closingdate||1-jan-2002|
|- Target number of participants||147|
|- Interventions||The Symptom Management Module (SMM), one of the independent living skills modules developed by the Los Angeles rehabilitation research group, is a psychosocial intervention to improve the capability of patients with schizophrenia to detect EWS of a psychosis and to learn the patients to manage them.
Two treatment conditions (symptom management module (N=46) vs self monitoring (N=52))and a comparison group (treatment as usual N=49) in patinets with schizophrenia or related psychotic disorders.|
|- Primary outcome||Occurence of a psychotic relapse: a worsening of at least two points on the CGI as assessed by psychiatrist and verified by researcher by a PANSS-interview within a week. |
|- Secondary outcome||1. Hospiatlisation; |
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. J. Arends|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. D. Wiersma|
|- Sponsor/Initiator ||Mental Health Care Services Drenthe, Department of Psychotic Disorders|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, National Foundation of Mental Health Care (NFGV), The Per V. Petersen Foundation, National Foundation: ‘De Open Ankh’, National Foundation ‘Stichting tot Steun’|
|- Publications||Relapse Prevention in Schizophrenia: a randomised controlled trial between self-Monitoring and Training with the symptom management module, and a comparison with Treatment As Usual (submitted).|
|- Brief summary||This study tested the effectiveness of an intervention that trained patients with schizophrenia with the Symptom Management Module (SMM) in terms of improvement in relapse risk and psychopathology during 18 months of follow-up compared with a self-monitoring of Early Warning Signs (EWS) intervention and treatment as usual. |
Both the training group as well as the self-monitoring group showed a significant less total number of relapses during the follow up period of 18 months in comparison with the treatment as usual group.
The patients in the training condition had fewer relapses, compared with the patients in the monitoring condition. The difference was nearly significant.
The results were neither influenced by age, gender, diagnosis, age of illness, number of previous relapses, number of previous hospitalisations, medication and employment status.
No difference in duration of rehospitalisation was observed between the training and the self-monitoring condition during the follow up period.
Conclusion: The study provides evidence that training with SMM and self-monitoring of EWS are effective interventions compared to standard care.
Training with SMM showed an additional relapse preventive effect compared with another rigorous intervention.
|- Main changes (audit trail)|
|- RECORD||13-sep-2005 - 20-mei-2008|