Stress Reduction in Middle Eastern Refugees

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark A. Lumley, Wayne State University
ClinicalTrials.gov Identifier:
NCT01288690
First received: January 27, 2011
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Post Traumatic Stress Disorder
Behavioral: Narrative Exposure Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stress Reduction in Middle Eastern Refugees

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Post traumatic stress disorder symptoms: Harvard Trauma Questionnaire [ Time Frame: Baseline to 4 months. ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 4 months. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 63
Study Start Date: December 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288690

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48209
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Mark A Lumley, Ph.D Wayne State University
  More Information

No publications provided

Responsible Party: Mark A. Lumley, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01288690     History of Changes
Other Study ID Numbers: WSU082810B3F
Study First Received: January 27, 2011
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wayne State University:
Refugees
Trauma
Narrative
Exposure
Middle East
Therapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014