Condition category
Mental and Behavioural Disorders
Date applied
17/09/2012
Date assigned
08/10/2012
Last edited
22/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.centrum45.nl/

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

http://www.zonmw.nl/en/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

22/02/2016: Publication reference added.