Stress Reduction in Middle Eastern Refugees

Study Overview
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Brief Summary
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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.

Official Title
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Stress Reduction in Middle Eastern Refugees

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Narrative Exposure Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Wait List Control<br>This condition is a wait-list control and receives no intervention during the study period, but is offered treatment after the final assessment. | |
| Experimental: Narrative Exposure Therapy<br>Patients in this condition receive 3 sessions of Narrative Exposure Therapy | Behavioral: Narrative Exposure Therapy<br>* 3, 1-1/2 hour sessions, individual, meeting weekly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post traumatic stress disorder symptoms: Harvard Trauma Questionnaire | 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. | Baseline to 4 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical symptoms: Patient Health Questionnaire | Physical 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. | Baseline to 4 months | 
| Depression symptoms: Beck Depression Inventory II | 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. | Baseline to 4 months. | 
| Quality of sleep: Karolinska Institute Sleep Questionnaire | Quality 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. | Baseline to 4 months | 
| Daily functioning | Daily 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. | Baseline to 4 months | 
| Post traumatic growth: Post Traumatic Growth Inventory | Positive 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. | Baseline to 4 months | 
| General Psychological Well-being: WHO Well-being Index | Markers 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. | Baseline to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refugees, Trauma, Narrative, Exposure, Middle East, Therapy