EMDR Intervention for Psychological Trauma Among Syrian Refugees

Sponsor

Istanbul Sehir University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01847742

Collaborator

(none)

Enrollment

Location

Arms

10.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To implement an EMDR (Eye Movement Desensitization and Reprocessing)intervention to treat the trauma symptoms among Syrian Refugees.

Condition or Disease	Intervention/Treatment	Phase
Psychological Trauma	Behavioral: Eye Movement Desensitization and Reprocessing Therapy	N/A

Detailed Description

In this project we aim to treat the posttraumatic stress disorder (PTSD) symptoms among Syrian refugees through an effective psycho-therapy technique called Eye Movement Desensitization and Reprocessing (EMDR). Randomly selected refugees will be assessed through MINI PLUS for the diagnose of PTSD. Eighty refugees with PTSD will be randomly allocated to either 7 sessions EMDR or wait-list control group.Symptoms of PTSD (MINI PLUS, HTQ, IES-R) and depression and anxiety (BDI, HSCL)will be assessed at pre- and post-treatment and 4 weeks follow-up.

However, to our knowledge this is one of the first intervention studies which will be conducted in a refugee camp. Therefore we expect to have some practical and logical problems. In order to see the feasibility and efficacy of EMDR among Syrian refugees, before the main study we aim to run a pilot study with less participants. In the pilot we will assess the posttraumatic stress symptoms with Impact of Event Scale-Revised (IES-R) and the depressive symptoms through Beck Depression Inventory (BDI-II).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

EMDR Treatment for Psychological Trauma Among Syrian Refugees in Kilis, Randomized Controlled Trial.

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EMDR intervention 40 participants with trauma symptoms will be randomly assigned to treatment group and receive EMDR intervention for trauma symptoms.EMDR is a trauma focused therapy starts with resource development and continue with bilateral stimulation while working on the most troubling traumatic memory.	Behavioral: Eye Movement Desensitization and Reprocessing Therapy
No Intervention: Waiting List 40 participants with trauma symptoms will be randomly assigned to waiting list as the control group.

Arm

Intervention/Treatment

Experimental: EMDR intervention

40 participants with trauma symptoms will be randomly assigned to treatment group and receive EMDR intervention for trauma symptoms.EMDR is a trauma focused therapy starts with resource development and continue with bilateral stimulation while working on the most troubling traumatic memory.

Behavioral: Eye Movement Desensitization and Reprocessing Therapy

No Intervention: Waiting List

40 participants with trauma symptoms will be randomly assigned to waiting list as the control group.

Outcome Measures

Primary Outcome Measures

score on Harvard Trauma Questionnaire (at the main study) [before and after the treatment,an expected average of 7 weeks of EMDR treatment]
The change in HTQ score will be assessed after the EMDR treatment has finished after 7 weeks(estimated).
Impact of Event Scale Revised (at the pilot study and the main study) [pre- and post treatment]
The change in IES-R score will be assessed after the EMDR treatment has finished after 7 weeks(estimated).

Secondary Outcome Measures

score on HSCL for depressive and anxiety symptoms (at the main study) [before and after the treatment, an expected average of 7 weeks of EMDR treatment]
The change in HSCL score will be assessed after the EMDR treatment has finished in 7 weeks in average.
Score on BDI-II (pilot study and the main study) [before and after EMDR treatment, an expected average of 7 weeks of EMDR treatment]
A change in BDI-II will be assessed after the EMDR treatment has completed in 7 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

trauma symptoms

Exclusion Criteria:

pregnancy
current or past psychotic disorder
current or past substance abuse or dependence
serious physical illness
active suicidal ideation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kilis Camp for Refugees	Gaziantep		Turkey

Sponsors and Collaborators

Istanbul Sehir University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ceren Acarturk, Assistant Professor, Istanbul Sehir University

ClinicalTrials.gov Identifier:

NCT01847742

Other Study ID Numbers:

2013/1No:4

First Posted:

May 7, 2013

Last Update Posted:

Aug 9, 2013

Last Verified:

Aug 1, 2013

Additional relevant MeSH terms:

Wounds and Injuries

Psychological Trauma

Study Results

No Results Posted as of Aug 9, 2013