|- candidate number||8755|
|- NTR Number||NTR2648|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-dec-2010|
|- Secondary IDs||10-N-98 METC Atrium Orbis Zuyd|
|- Public Title||Observational study Psychiatric Medical Unit.|
|- Scientific Title||Observational study on the change in regular psychometrics after (short) stay on the PMU, on somatic as well as psychiatric symptomatology.|
|- hypothesis||(Short) stay and, if possible, treatment at the PMU, will give an improvement in regular psychometrics or at least in some of them.|
|- Healt Condition(s) or Problem(s) studied||Depressive disorders, Somatoform disorder, Anxiety disorders|
|- Inclusion criteria||1. > 18 yr;|
2. Reffered by GP, medical specialist or psychologist to the "Soma en Psyche" centre of the Atrium MC;
3. Axis I disorder according to DSM IV;
4. "SOLK" / Somatoform disorder according to DSM IV;
5. Informed consent.
|- Exclusion criteria||1. < 18 yr;|
2. Cognitive disorder / dementia according to DSM IV.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||13-dec-2010|
|- planned closingdate||13-dec-2011|
|- Target number of participants||20|
|- Interventions||The study is an observational study, no specific intervention will be studied, all of the interventions that are used on the PMU will be included, as needed in the individual treatment.
Most common interventions are:
1. (Re)activation (therapy);
2. Medication: Most common are; antidepressants, anxiolytic med., antipsychotic med., benzodiazepines;
The study is an observational study, so there will be no placebo/non-interventiongroup.
In this study we only want to observe systematically if there's any change on regular standard psychometrics before and after stay at the PMU. And if there's a change; describe the trend that can be seen.
|- Primary outcome||Change in somatic as well as psychiatric symptomatology.|
|- Secondary outcome||Change in health related Quality of Life.|
|- Timepoints||t0 (day 1 at PMU):|
1. MINI (Mini-International Neuropsychiatric Interview);
2. JTV-SV (Jeugd Trauma Vragenlijst 1997);
3. HADS (Hospital Anxiety and Depression Scales);
4. HAM-D (Hamilton Rating Scale for Depression);
5. SCL-90 (Symptom Checklist);
6. ORS (Outcome Rating Scale);
7. WHO Quality of life questionnaire.
T=1 week: ORS;
T=2 weeks: HADS, HAM-D, ORS;
T=8 weeks: WHO Quality of life questionnaire, SCL-90, HADS, HAM-D, ORS.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. H.J.H. Bremer|
|- CONTACT for SCIENTIFIC QUERIES|| M. Dremmen|
|- Sponsor/Initiator ||Atrium Medical Center, Heerlen|
(Source(s) of Monetary or Material Support)
|Atrium Medical Center, Heerlen|
|- Brief summary||The psychiatric Medical unit of the Atrium MC in Heerlen is one of three in Limburg and Noord Brabant (others are located in Eindhoven en Maastricht). Suitable patients for stay at the PMU are patients with a psyciatric disorder as well as a somatic disorder. Very common is the somatoform disorder, fibromyalgia and IBS etc. Frequently seen psychiatric comorbidity are anxiety disorder and depressive disorder. Patients are referred by medical specialist, GP, clinical psychologist or mental health institution. At the PMU furter analysis will be performed, next to observation and (if possible) start of treatment.|
The study is an observational study, no specific intervention will be studied, all of the interventions that are used on the PMU will be included, as needed in the individual treatment. There will be no placebo/non-interventiongroup.
In this study we want to observe systematically if there's any change on regular standard psychometrics before and after stay at the PMU. And if there's a change; describe the trend that can be seen. Patient will be recruited only in the Netherlands.
|- Main changes (audit trail)|
|- RECORD||10-dec-2010 - 27-dec-2010|