Equator evaluation study: evaluation of the equator day care treatment for traumatised refugees

ISRCTN	ISRCTN52861559
DOI	https://doi.org/10.1186/ISRCTN52861559
Protocol serial number	NTR910
Sponsor	Academic Medical Centre (The Netherlands)
Funders	European Refugee Fund (Belgium), Added as of 06/10/2008:, The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands). The funding from ZonMw will start on 1st January 2009 and end on 1st July 2009.

Submission date: 07/03/2007
Registration date: 07/03/2007
Last edited: 03/07/2019

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 Astrid Kamperman
Scientific

Equator
Academic Medical Centre
University of Amsterdam
Department of Psychiatry
Meibergdreef 5
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 8913639
Email	A.M.Kamperman@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Non-randomised, controlled, parallel group clinical trial
Secondary study design	Non randomised controlled trial
Scientific title	Equator evaluation study: evaluation of the equator day care treatment for traumatised refugees
Study objectives	Suffering from mental health problems constitutes a major obstacle for successful integration into Dutch society for refugees. The majority of refugees report 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, the Academic Medical Centre (AMC) 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-reliance, 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 affecting 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? 2.a. What are the short and long term effects of the Equator day care treatment on the mental health of refugees? 2.b. What are the short and long term effects of refugees of the Equator day care treatment on the social integration? The 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.
Ethics approval(s)	Approval received from the Medical Ethical Commission of the Academic Medical Centre (University of Amsterdam) on the 22nd November 2006 (ref: 06.17.1651).
Health condition(s) or problem(s) studied	Refugees, mental health
Intervention	Equator day care treatment is a three days a week group intervention over a six month period. 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 backgrounds 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 stabilising the mental health status and regaining control over effect and behaviour. Medication is central in this approach. Individual counselling with a psychologist or psychiatrist has a supporting nature. If indicated a psychotherapeutic or trauma focused therapy is started. The community approach consists of a socio-therapeutic 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.
Intervention type	Other
Primary outcome measure(s)	T0: start of intervention T1: end of intervention (T0 and six months) T2: three-months follow-up T3: six-months follow-up Method: assisted self-administering using a structured questionnaire. Questionnaire is translated in the mother tongue of the respondent. Complete questionnaire: 1. Diagnostics: a. Psychopathology (Mini International Neuropsychiatric Interview Plus [MINIPlus]) b. Post-Traumatic Stress Syndrome (PTSS) (Clinician-Administered PTSS Scale [CAPS]) 2. Socio-demographics: traumatic events (Stressful Life Events [SLE]-Equator; questionnaire developed for this particular study) 3. Mental health: a. Impact of events (Impact of Event Scale-Revised [IES-R]) b. Anxiety and depression symptoms (Hamilton Anxiety Depression Scale [HADS]) c. Disability and wellbeing (Medical Outcomes Study short-form general health survey 36 MOS-sf-36) d. Somatic complaints (Subjective Health Complaint [SHC]) 4. Social integration: a. Social capital (ASCAT) b. Social support (Social Support List-Interactions [SSL-I]) c. Acculturation questionnaire (Language Assessment Scales [LAS]) d. Loneliness (questionnaire developed for this particular study) e. Frequency and quality of interaction/communication (questionnaire developed for this particular study) 5. Patient satisfaction
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	15/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	60
Total final enrolment	72
Key inclusion criteria	Treatment group: Equator day care patients: adult refugees with severe trauma related mental health problems Control group: refugees in population, matched on sex, age, ethnicity and living area
Key exclusion criteria	1. Disturbed reality testing 2. Mentally retarded 3. No residence permit 4. Simultaneously receiving comparable mental health treatment
Date of first enrolment	14/08/2006
Date of final enrolment	15/08/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Equator

Amsterdam
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/09/2012	03/07/2019	Yes	No

Editorial Notes

03/07/2019: Publication reference and total final enrolment added.