EMDR Intervention for Psychological Trauma Among Syrian Refugees

Psychological Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01847742
• Other study ID #: 2013/1No:4
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2013
• Last updated: August 7, 2013
• Start date: April 2013
• Est. completion date: February 2014

Study information

• Verified date: August 2013
• Source: Istanbul Sehir University
• Contact: Ceren Acarturk, PhD
• Phone: 0090216444 4034
• Email: cerenacarturk[@]sehir.edu.tr
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychological Trauma
• Wounds and Injuries

Intervention

Behavioral:
• Eye Movement Desensitization and Reprocessing Therapy

Locations

Country	Name	City	State
Turkey	Kilis Camp for Refugees	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Sehir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	score on Harvard Trauma Questionnaire (at the main study)	The change in HTQ score will be assessed after the EMDR treatment has finished after 7 weeks(estimated).	before and after the treatment,an expected average of 7 weeks of EMDR treatment	No
Primary	Impact of Event Scale Revised (at the pilot study and the main study)	The change in IES-R score will be assessed after the EMDR treatment has finished after 7 weeks(estimated).	pre- and post treatment	No
Secondary	score on HSCL for depressive and anxiety symptoms (at the main study)	The change in HSCL score will be assessed after the EMDR treatment has finished in 7 weeks in average.	before and after the treatment, an expected average of 7 weeks of EMDR treatment	No
Secondary	Score on BDI-II (pilot study and the main study)	A change in BDI-II will be assessed after the EMDR treatment has completed in 7 weeks.	before and after EMDR treatment, an expected average of 7 weeks of EMDR treatment	No