Stress Reduction in Middle Eastern Refugees

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.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Narrative Exposure Therapy

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48209
      • Wayne State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Wait List Control; 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; Patients in this condition receive 3 sessions of Narrative Exposure Therapy	Behavioral: Narrative Exposure Therapy; 3, 1-1/2 hour sessions, individual, meeting weekly.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wayne State University
• Investigators: Principal Investigator: Mark A Lumley, Ph.D, Wayne State University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: February 1, 2011
• First Posted (Estimate): February 2, 2011

Study Record Updates

• Last Update Posted (Estimate): June 17, 2013
• Last Update Submitted That Met QC Criteria: June 13, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Therapy; Trauma; Exposure; Refugees; Narrative; Middle East
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: WSU082810B3F