- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01847742
EMDR Intervention for Psychological Trauma Among Syrian Refugees
EMDR Treatment for Psychological Trauma Among Syrian Refugees in Kilis, Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ceren Acarturk, PhD
- Phone Number: 9853 0090216444 4034
- Email: cerenacarturk@sehir.edu.tr
Study Locations
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Gaziantep, Turkey
- Recruiting
- Kilis Camp for Refugees
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Contact:
- Mustafa Cetinkaya, MA
- Email: mustafacetinkaya80@gmail.com
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Principal Investigator:
- Mustafa Cetinkaya, MA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant 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.
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No Intervention: Waiting List
40 participants with trauma symptoms will be randomly assigned to waiting list as the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
score on Harvard Trauma Questionnaire (at the main study)
Time Frame: before and after the treatment,an expected average of 7 weeks of EMDR treatment
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The change in HTQ score will be assessed after the EMDR treatment has finished after 7 weeks(estimated).
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before and after the treatment,an expected average of 7 weeks of EMDR treatment
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Impact of Event Scale Revised (at the pilot study and the main study)
Time Frame: pre- and post treatment
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The change in IES-R score will be assessed after the EMDR treatment has finished after 7 weeks(estimated).
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pre- and post treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
score on HSCL for depressive and anxiety symptoms (at the main study)
Time Frame: 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.
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before and after the treatment, an expected average of 7 weeks of EMDR treatment
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Score on BDI-II (pilot study and the main study)
Time Frame: before and after EMDR treatment, an expected average of 7 weeks of EMDR treatment
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A change in BDI-II will be assessed after the EMDR treatment has completed in 7 weeks.
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before and after EMDR treatment, an expected average of 7 weeks of EMDR treatment
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/1No:4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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