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Stress Reduction in Middle Eastern Refugees

Stress Reduction in Middle Eastern Refugees

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01288690
Enrollment
63
Registered
2011-02-02
Start date
2010-12-31
Completion date
2012-08-31
Last updated
2013-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

Keywords

Refugees, Trauma, Narrative, Exposure, Middle East, Therapy

Brief summary

This interventional, randomized controlled study tests the effects of a a brief psychological intervention (Narrative Exposure Therapy) against a wait list control group among refugees who have experienced trauma and have some symptoms of PTSD.

Interventions

BEHAVIORALNarrative Exposure Therapy

3, 1-1/2 hour sessions, individual, meeting weekly.

Sponsors

Wayne State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Refugees from the Middle East, and possible from Africa, who have experienced conflict-related trauma, have symptoms of PTSD, and speak either Arabic or English

Exclusion criteria

* Currently received exposure therapy for PTSD * Planning to leave area in next 4 months

Design outcomes

Primary

MeasureTime frameDescription
Post traumatic stress disorder symptoms: Harvard Trauma QuestionnaireBaseline to 4 months.The number and severity of post traumatic stress disorder symptoms will be assessed using an Arabic adaptation of the Harvard Trauma Questionnaire. The Harvard Trauma Questionnaire will be administered at baseline prior to randomization and 4 months from baseline (about three months from last intervention session). Questions assess symptoms over the preceding one week.

Secondary

MeasureTime frameDescription
Depression symptoms: Beck Depression Inventory IIBaseline to 4 months.Depression symptoms will be assessed using an Arabic translation of the Beck Depression Inventory II. The scale will be administered at baseline prior to randomization, and 4 months from baseline (about three months from last intervention session). The questions assess symptoms over the preceding two weeks.
Quality of sleep: Karolinska Institute Sleep QuestionnaireBaseline to 4 monthsQuality of sleep will be assessed using an Arabic translation of five items from the Karolinska Institute Sleep Questionnaire. The scale will be administered at baseline prior to randomization, and 4 months from baseline (about three months from last intervention session). The questions don't specify a time frame for the symptoms.
Physical symptoms: Patient Health QuestionnaireBaseline to 4 monthsPhysical symptoms will be assessed using an Arabic translation of the Patient Health Questionnaire at baseline prior to randomization, and 4 months from baseline (about three months from last intervention session). Questions assess symptoms over the preceding 4 weeks.
Post traumatic growth: Post Traumatic Growth InventoryBaseline to 4 monthsPositive and growth outcomes sometimes experienced by people who have experienced traumatic events will be assessed using an Arabic translation of the Post Traumatic Growth Inventory. The scale will be administered at baseline prior to randomization, and 4 months from baseline (about three months from last intervention session). The questions do not specify a time frame.
General Psychological Well-being: WHO Well-being IndexBaseline to 4 monthsMarkers of mental well-being such as positive mood, vitality and interest will be assessed using the Arabic version of the World Health Organization's Well-being Index. The scale will be administered at baseline prior to randomization, and 4 months from baseline (about three months from last intervention session). The questions assess functioning in the preceding two weeks.
Daily functioningBaseline to 4 monthsDaily functioning is assessed using 8 items developed by the Primary Investigator in collaboration with other colleagues. The items assess areas such as spending time with family and friends, utilizing health, immigration, language, and employment services, and participating in religious and social activities. The scale will be administered at baseline prior to randomization, and 4 months from baseline (about three months from last intervention session).The questions assess functioning over the preceding 4 weeks.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026