EMDR Intervention for Psychological Trauma Among Syrian Refugees
Primary Purpose
Psychological Trauma
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Eye Movement Desensitization and Reprocessing Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Psychological Trauma
Eligibility Criteria
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
Sites / Locations
- Kilis Camp for RefugeesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EMDR intervention
Waiting List
Arm Description
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.
40 participants with trauma symptoms will be randomly assigned to waiting list as the control group.
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01847742
First Posted
April 21, 2013
Last Updated
August 7, 2013
Sponsor
Istanbul Sehir University
1. Study Identification
Unique Protocol Identification Number
NCT01847742
Brief Title
EMDR Intervention for Psychological Trauma Among Syrian Refugees
Official Title
EMDR Treatment for Psychological Trauma Among Syrian Refugees in Kilis, Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Sehir University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To implement an EMDR (Eye Movement Desensitization and Reprocessing)intervention to treat the trauma symptoms among Syrian Refugees.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EMDR intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting List
Arm Type
No Intervention
Arm Description
40 participants with trauma symptoms will be randomly assigned to waiting list as the control group.
Intervention Type
Behavioral
Intervention Name(s)
Eye Movement Desensitization and Reprocessing Therapy
Primary Outcome Measure Information:
Title
score on Harvard Trauma Questionnaire (at the main study)
Description
The change in HTQ score will be assessed after the EMDR treatment has finished after 7 weeks(estimated).
Time Frame
before and after the treatment,an expected average of 7 weeks of EMDR treatment
Title
Impact of Event Scale Revised (at the pilot study and the main study)
Description
The change in IES-R score will be assessed after the EMDR treatment has finished after 7 weeks(estimated).
Time Frame
pre- and post treatment
Secondary Outcome Measure Information:
Title
score on HSCL for depressive and anxiety symptoms (at the main study)
Description
The change in HSCL score will be assessed after the EMDR treatment has finished in 7 weeks in average.
Time Frame
before and after the treatment, an expected average of 7 weeks of EMDR treatment
Title
Score on BDI-II (pilot study and the main study)
Description
A change in BDI-II will be assessed after the EMDR treatment has completed in 7 weeks.
Time Frame
before and after EMDR treatment, an expected average of 7 weeks of EMDR treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ceren Acarturk, PhD
Phone
0090216444 4034
Ext
9853
Email
cerenacarturk@sehir.edu.tr
Facility Information:
Facility Name
Kilis Camp for Refugees
City
Gaziantep
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Cetinkaya, MA
Email
mustafacetinkaya80@gmail.com
First Name & Middle Initial & Last Name & Degree
Mustafa Cetinkaya, MA
12. IPD Sharing Statement
Citations:
PubMed Identifier
27353367
Citation
Acarturk C, Konuk E, Cetinkaya M, Senay I, Sijbrandij M, Gulen B, Cuijpers P. The efficacy of eye movement desensitization and reprocessing for post-traumatic stress disorder and depression among Syrian refugees: results of a randomized controlled trial. Psychol Med. 2016 Sep;46(12):2583-93. doi: 10.1017/S0033291716001070. Epub 2016 Jun 29.
Results Reference
derived
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EMDR Intervention for Psychological Trauma Among Syrian Refugees
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