|- candidate number||2474|
|- NTR Number||NTR910|
|- Date ISRCTN created||7-mrt-2007|
|- date ISRCTN requested||6-mrt-2007|
|- Date Registered NTR||16-feb-2007|
|- Secondary IDs||N/A |
|- Public Title||Equator Evaluation Study|
|- Scientific Title||Evaluation of the Equator day care treatment for traumatized refugees|
|- hypothesis||General hypothesis of the study is that the Equator day care treatment results in a significant improvement on indicators of mental health and social integration, compared to a control group consisting of respondents that did not receive Equator day care treatment.|
|- Healt Condition(s) or Problem(s) studied||Treatment effectiveness, Mental health, Refugees, Social integration|
|- Inclusion criteria||Treatment group: Equator day care patients
Control group: refugees in population, matched on sex, age, etnicity and living area.|
|- Exclusion criteria||1. Disturbed reality testing; |
2. Mentally retardation;
3. No residence permit;
4. Simultaniously receiving comparable mental health treatment.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||14-aug-2006|
|- planned closingdate||15-aug-2009|
|- Target number of participants||60|
|- Interventions||Equator day care treatment is a three days a week group intervention over a 6 months period. Patients of Equator day care treatment are adult refugees with severe trauma related mental health problems. Per year, around 40 refugee patients attend the Equator day care treatment. Most patients are men (+/- 70%), as most refugees in The Netherlands are men. The background of these patients are Afghan, Irakese, Iranese, Sierra Leonese, Rwandese, Burundese, Angolese, Somalian etc.
The treatment integrates a psychiatric and a community approach to mental illness. The psychiatric approach aims at stabilizing the mental health status and regaining control over affect and behaviour. Medication is central in this approach. Individual counseling with a psychologists or psychiatrist has a supporting nature. If indicated a psychotherapeutic or trauma focused therapy is started. The community approach consists of a sociotherapeutic intervention. This intervention aims at increasing social functioning. The therapeutic environment helps in regaining a basic sense of security.
The control group will be sampled from the adult refugee population living in the Netherlands.The control group will be matched on sex, ethnicity and living area.
|- Primary outcome||1. Mental health:|
Impact of Event Scale-Revised (IES-R) (Weiss & Marmar, 1997).
T0: start of intervention
T1: end of intervention (T0 + 6 months)
T2: 3-months folluw-up
T3: 6-months follow-up
Method: Assisted self administering using a structured questionnaire. Questionnaire is translated in the mothertongue of the respondent.
a. Psychopathology (MINIPlus; Sheehan et al., 1998)
b. PTSS (CAPS; Blake et al., 1995);
B. Socio-demographics: Traumatic Events (SLE-Equator; questionnaire developed for this particular study);
C. Mental Health:
a. Impact of Events (IES-R; Wess & marmar, 1997)
b. Anxiety and depression symptoms (HADS; Zigmond & Snaith, 1983)
c. Disability and wellbeing (MOS-sf-36; Ware et al., 1996)
d. Somatic complaints (SHC; Eriksen, Ihleback & Ursin, 1999)
D. Social Integration:
a. Social Capital (ASCAT; McKenzie, 2006)
b. Social Support (SSL-I; van Sonderen, 1993)
c. Acculturation questionnaire (LAS; Mooren et al., 2001)
d. Loneliness (questionnaire developed for this particular study)
e. Frequency and quality of interaction/communication (questionnaire developed for this particular study)
E. Patient satisfaction
|- Secondary outcome||Social Integration (ASCAT; McKenzie, 2006)|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD Astrid Kamperman|
|- CONTACT for SCIENTIFIC QUERIES||MD W.F. Scholte|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, European Refugee Fund|
|- Brief summary||Suffering from mental health problems constitutes a major obstacle for succesful integration into Dutch society for refugees. The majority of refugees reports one or more psychiatric disorders, often related to previously experienced traumatic events. To those refugees whose problems are of such severe nature that mental health treatment is indicated, AMC De Meren offers the Equator day care treatment. Equator day care treatment aims at the decrease of trauma related mental health problems. Moreover, the treatment aims at strengthening the patient's self relience, and offers techniques for the improvement of social (re)integration. This study has the objective to evaluate Equator day care treatment and to define factors effecting treatment effectiveness. Consequently the study hopes to increase the body of knowledge with respect to the relationship between mental health and social integration.
The research questions of the study are:
1) What is the relationship between mental health and social integration?
2a) What are the short and long term effects of the Equator day care treatment on the mental health of refugees?
2b) What are the short and long term effects of refugees of the Equator day care treatment on the social integration ?
In this study 30 Equator day care patients and 30 refugees from the general population are assessed on indicators of mental health and social integration over a 1 year period.|
|- Main changes (audit trail)|
|- RECORD||16-feb-2007 - 22-sep-2008|