Eye movement desensitization and reprocessing (EMDR) versus stabilisation in the treatment of traumatised asylum seekers and refugees
| ISRCTN | ISRCTN20310201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20310201 |
| Secondary identifying numbers | NARCIS OND1324839 |
- Submission date
- 17/09/2012
- Registration date
- 08/10/2012
- Last edited
- 22/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Traumatised asylum seekers and refugees are often clinically considered a complex population. Many of them suffer from posttraumatic stress disorder (PTSD), which may be related not only to traumatic experiences but also to current stressful situations, such as an insecure residency status. For the psychological treatment of single traumatic events, Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive-Behavioral Therapy (CBT) are considered "treatments of choice", meaning that they should be offered to patients with PTSD. Both are treatments that involve confrontation with traumatic memories. Whether these treatments also work well with asylum seekers and refugees has been a question of debate. It is considered "good clinical practice" to use a phased model of treatment with these patients, in which treatment initially focuses on psychosocial stabilisation and only later, if at all, on the traumatic memories. There are however indications that this group could benefit from early EMDR, without first undergoing a long stabilisation phase. The study has been designed to answer the question: is EMDR better than stabilisation in reducing posttraumatic symptoms in traumatised asylum seekers and refugees? The aim of the study is to improve the treatment of traumatised asylum seekers and refugees. Considering previous study outcomes, we expect that EMDR will work better than stabilisation.
Who can participate?
Participants will be adult asylum seekers and refugees who suffer from PTSD and who have applied for outpatient treatment.
What does the study involve?
In this study, participants will be randomly assigned to either 12 hours of EMDR or 12 hours of stabilisation. Another group of patients will be asked to participate in a waitlist condition. The study aims to include 108 participants. Participants will answer interview questions and questionnaires on trauma symptoms, anxiety and depression, quality of life, and ways of coping with stressful situations.
What are the possible benefits and risks of participating?
The study has been ethically approved and no side effects are expected from participating. Participation brings no specific benefits. Patients who decide not to participate are entitled to the usual care.
Where is the study run from?
The study is run from Centrum 45, which is a Dutch psychotrauma expert centre.
When is the study starting and how long is it expected to run for?
The study has started in September 2009, and we expect to finish it by the end of 2012.
Who is funding the study?
The study is partially funded by ZonMW, the Netherlands organization for health research and development, and updates on the progress of the study may be found on their website, www.zonw.nl (add /en/ for information in English).
Who is the main contact?
Jackie June ter Heide
j.ter.heide@centrum45.nl
Contact information
Scientific
Foundation Centrum '45
Nienoord 5
Diemen
1112 XE
Netherlands
| Phone | +31 (0)20 6 274 974 |
|---|---|
| j.ter.heide@centrum45.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet [Dutch] |
| Scientific title | Eye movement desensitization and reprocessing (EMDR) versus stabilisation in the treatment of traumatised asylum seekers and refugees: a randomised controlled trial |
| Study objectives | Eye movement desensitization and reprocessing (EMDR) will be more efficacious than stabilisation or waiting list in reducing post-traumatic stress, anxiety and depression, and increasing quality of life. |
| Ethics approval(s) | Medical Ethical Committee, University of Leiden, 25/07/2007, ref: P06.211 |
| Health condition(s) or problem(s) studied | Post Traumatic Stress Disorder (PTSD) |
| Intervention | 72 participants are randomly assigned to either EMDR or stabilisation as usual, and 36 participants are non-randomly asssigned to a waitinglist group. |
| Intervention type | Other |
| Primary outcome measure | Posttraumatic stress disorder (PTSD) as measured by the Clinician-Administered PTSD Scale (CAPS) and the Harvard Trauma Questionnaire (HTQ) |
| Secondary outcome measures | 1. Anxiety and depression as measured by the Hopkins Symptom Checklist (HSCL-25) 2. Quality of life as measured by the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) 3. Coping styles as measured by the Cope-Easy |
| Overall study start date | 01/09/2009 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 108 |
| Key inclusion criteria | 1. Patients who newly apply for treatment at Centrum 45 2. Patients who have applied for asylum in the Netherlands (i.e. are asylum seekers or refugees) 3. Patients who are at least 18 years old 4. Patients who meet the criteria for a posttraumatic stress disorder (PTSD)-diagnosis according to the DSM-IV-TR (APA, 2000) |
| Key exclusion criteria | 1. Patients who suffer from serious depression (i.e. with high suicidal intent and/or psychotic features) 2. Patients who suffer from alcohol or substance dependence 3. Patients who suffer from psychotic disorder, bipolar disorder, cognitive disorders, or automutilation or eating disorders threatening their physical health. |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1112 XE
Netherlands
Sponsor information
Government
Postbox 93 245
The Hague
2509 AE
Netherlands
| Phone | +31 (0)70 349 51 11 |
|---|---|
| info@zonmw.nl | |
| Website | http://www.zonmw.nl/en/ |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
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 of pilot study | 01/05/2011 | Yes | No | |
| Results article | results | 01/10/2016 | Yes | No |
Editorial Notes
22/02/2016: Publication reference added.
