NCT01847742

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

8 months

First QC Date

April 21, 2013

Last Update Submit

August 7, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • 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

  • Score on BDI-II (pilot study and the main study)

    before and after EMDR treatment, an expected average of 7 weeks of EMDR treatment

Study Arms (2)

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.

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.

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • trauma symptoms

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilis Camp for Refugees

Gaziantep, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 21, 2013

First Posted

May 7, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations