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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Study website

Contact information

Ms Jackie June ter Heide
Scientific

Foundation Centrum '45
Nienoord 5
Diemen
1112 XE
Netherlands

Phone +31 (0)20 6 274 974
Email j.ter.heide@centrum45.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet [Dutch]
Scientific titleEye movement desensitization and reprocessing (EMDR) versus stabilisation in the treatment of traumatised asylum seekers and refugees: a randomised controlled trial
Study objectivesEye 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) studiedPost Traumatic Stress Disorder (PTSD)
Intervention72 participants are randomly assigned to either EMDR or stabilisation as usual, and 36 participants are non-randomly asssigned to a waitinglist group.
Intervention typeOther
Primary outcome measurePosttraumatic stress disorder (PTSD) as measured by the Clinician-Administered PTSD Scale (CAPS) and the Harvard Trauma Questionnaire (HTQ)
Secondary outcome measures1. 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 date01/09/2009
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants108
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2009
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Foundation Centrum '45
Diemen
1112 XE
Netherlands

Sponsor information

The Netherlands Organisation for Health Research and Development [ZonMw] (Netherlands)
Government

Postbox 93 245
The Hague
2509 AE
Netherlands

Phone +31 (0)70 349 51 11
Email info@zonmw.nl
Website http://www.zonmw.nl/en/
ROR logo "ROR" https://ror.org/01yaj9a77

Funders

Funder type

Government

ZonMw, ref: 100002036
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.