Equator evaluation study: evaluation of the equator day care treatment for traumatised refugees
| ISRCTN | ISRCTN52861559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52861559 |
| Secondary identifying numbers | NTR910 |
- 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
Scientific
Equator
Academic Medical Centre
University of Amsterdam
Department of Psychiatry
Meibergdreef 5
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 8913639 |
|---|---|
| A.M.Kamperman@amc.uva.nl |
Study information
| Study design | Non-randomised, controlled, parallel group clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 | 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 |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 14/08/2006 |
| Completion date | 15/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Equator
Academic Medical Centre
University of Amsterdam
Department of Psychiatry
Meibergdreef 5
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Government
European Refugee Fund (Belgium)
No information available
Added as of 06/10/2008:
No information available
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.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
