Back to resultsStress Reduction in Middle Eastern Refugees
Primary Purpose
Post Traumatic Stress Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Narrative Exposure Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Refugees, Trauma, Narrative, Exposure, Middle East, Therapy
Eligibility Criteria
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
Sites / Locations
- Wayne State University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Wait List Control
Narrative Exposure Therapy
Arm Description
This condition is a wait-list control and receives no intervention during the study period, but is offered treatment after the final assessment.
Patients in this condition receive 3 sessions of Narrative Exposure Therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01288690
Brief Title
Stress Reduction in Middle Eastern Refugees
Official Title
Stress Reduction in Middle Eastern Refugees
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Refugees, Trauma, Narrative, Exposure, Middle East, Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
This condition is a wait-list control and receives no intervention during the study period, but is offered treatment after the final assessment.
Arm Title
Narrative Exposure Therapy
Arm Type
Experimental
Arm Description
Patients in this condition receive 3 sessions of Narrative Exposure Therapy
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy
Intervention Description
3, 1-1/2 hour sessions, individual, meeting weekly.
Primary Outcome Measure Information:
Title
Post traumatic stress disorder symptoms: Harvard Trauma Questionnaire
Description
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.
Time Frame
Baseline to 4 months.
Secondary Outcome Measure Information:
Title
Physical symptoms: Patient Health Questionnaire
Description
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.
Time Frame
Baseline to 4 months
Title
Depression symptoms: Beck Depression Inventory II
Description
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.
Time Frame
Baseline to 4 months.
Title
Quality of sleep: Karolinska Institute Sleep Questionnaire
Description
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.
Time Frame
Baseline to 4 months
Title
Daily functioning
Description
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.
Time Frame
Baseline to 4 months
Title
Post traumatic growth: Post Traumatic Growth Inventory
Description
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.
Time Frame
Baseline to 4 months
Title
General Psychological Well-being: WHO Well-being Index
Description
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.
Time Frame
Baseline to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Lumley, Ph.D
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stress Reduction in Middle Eastern Refugees
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