Equator Evaluation Study

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR910
• Date of registration: 16/02/2007
• Primary sponsor: Academic Medical Center (AMC)
• Public title: Equator Evaluation Study
• Scientific title: Evaluation of the Equator day care treatment for traumatized refugees - N/A
• Date of first enrolment: 14/8/2006
• Target sample size: 60
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=910
• Study type: intervention
• Study design: Randomised: No; Masking: None; Control: Not applicable; Group: Parallel; Type: 2 or more arms, non-randomized

Countries of recruitment

The Netherlands

Contacts

• Name: W.F. Scholte

• Name: Astrid Kamperman

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Treatment effectiveness, Mental health, Refugees, Social integration

Intervention(s)

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(s)

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.


Complete questionnaire:

A. Diagnostics:

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(s)

Social Integration (ASCAT; McKenzie, 2006)

Secondary ID(s)

ISRCTN52861559

N/A

Source(s) of Monetary Support

ZON-MW, The Netherlands Organization for Health Research and Development, European Refugee Fund