Psychological TraumaNCT01847742
EMDR Intervention for Psychological Trauma Among Syrian Refugees
A study testing Eye Movement Desensitization and Reprocessing Therapy in people with Psychological Trauma, run by Istanbul Sehir University at 1 site in Turkey (Türkiye).
Trial summary
To implement an EMDR (Eye Movement Desensitization and Reprocessing)intervention to treat the trauma symptoms among Syrian Refugees. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychological Trauma
- What is being tested?
- Eye Movement Desensitization and Reprocessing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- trauma symptoms
Who cannot join
- pregnancy
- current or past psychotic disorder
- current or past substance abuse or dependence
- serious physical illness
- active suicidal ideation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kilis Camp for Refugees
Gaziantep
Mustafa Cetinkaya, MA, mustafacetinkaya80@gmail.com
Mustafa Cetinkaya, MA
About this study
Official title: EMDR Treatment for Psychological Trauma Among Syrian Refugees in Kilis, Randomized Controlled Trial.
To implement an EMDR (Eye Movement Desensitization and Reprocessing)intervention to treat the trauma symptoms among Syrian Refugees.
Read the 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).
- Conditions
- Psychological Trauma
- Being tested
- Eye Movement Desensitization and Reprocessing Therapy
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and Reprocessing TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| EMDR intervention | Experimental | 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. Receives: Behavioral: Eye Movement Desensitization and Reprocessing Therapy |
| Waiting List | No intervention | 40 participants with trauma symptoms will be randomly assigned to waiting list as the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: before and after the treatment,an expected average of 7 weeks of EMDR treatment
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).
Measured: pre- and post treatment
Secondary outcomes (2)
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.
Measured: before and after the treatment, an expected average of 7 weeks of EMDR treatment
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.
Measured: before and after EMDR treatment, an expected average of 7 weeks of EMDR treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Sehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Acarturk, Istanbul Sehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847742
- Sponsor's protocol ID
- 2013/1No:4
- Status last verified
- Aug 2013
- First submitted
- 21 Apr 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27353367
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMDR Treatment for Psychological Trauma Among Syrian Refugees in Kilis, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01847742
- Acronym / sponsor ID
- 2013/1No:4
- Conditions
- Psychological Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul Sehir UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMDR intervention | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing Therapy40 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. |
| Waiting List | No intervention | –40 participants with trauma symptoms will be randomly assigned to waiting list as the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- trauma symptoms
Key exclusion criteria (5 listed)
- pregnancy
- current or past psychotic disorder
- current or past substance abuse or dependence
- serious physical illness
- active suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Movement Desensitization and Reprocessing Therapy | Behavioural | EMDR intervention |
Primary outcome
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
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)
Time frame: pre- and post treatment
The change in IES-R score will be assessed after the EMDR treatment has finished after 7 weeks(estimated).
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
- Derived from this study: PubMed 27353367Acarturk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing Therapy in people with Psychological Trauma, run by Istanbul Sehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ceren Acarturk, PhD (0090216444 4034 ext. 9853, cerenacarturk@sehir.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01847742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2013; AzTrials last refreshed its copy on 6 Nov 2026.