Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Ms Jackie June ter Heide
ORCID ID
Contact details
Foundation Centrum '45
Nienoord 5
Diemen
1112 XE
Netherlands
+31 (0)20 6 274 974
j.ter.heide@centrum45.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NARCIS OND1324839
Study information
Scientific title
Eye movement desensitization and reprocessing (EMDR) versus stabilisation in the treatment of traumatised asylum seekers and refugees: a randomised controlled trial
Acronym
Study hypothesis
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
Medical Ethical Committee, University of Leiden, 25/07/2007, ref: P06.211
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet [Dutch]
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/09/2009
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
108
Participant 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.
Recruitment start date
01/09/2009
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Foundation Centrum '45
Diemen
1112 XE
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development [ZonMw] (Netherlands)
Sponsor details
Postbox 93 245
The Hague
2509 AE
Netherlands
+31 (0)70 349 51 11
info@zonmw.nl
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
ZonMw, ref: 100002036
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results of pilot study in: http://www.ncbi.nlm.nih.gov/pubmed/22893808
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26892849
Publication citations
-
Results of pilot study
Ter Heide FJ, Mooren TM, Kleijn W, de Jongh A, Kleber RJ, EMDR versus stabilisation in traumatised asylum seekers and refugees: results of a pilot study., Eur J Psychotraumatol, 2011, 2, doi: 10.3402/ejpt.v2i0.5881.
-
Results
Ter Heide FJ, Mooren TM, van de Schoot R, de Jongh A, Kleber RJ, Eye movement desensitisation and reprocessing therapy v. stabilisation as usual for refugees: randomised controlled trial, Br J Psychiatry, 2016, doi: 10.1192/bjp.bp.115.167775.