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Completed

NCT Number: NCT01288690

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wayne State University

Detroit, Michigan, 48209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narrative Exposure Therapy

Behavioral

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

Primary outcomes

  1. Post traumatic stress disorder symptoms: Harvard Trauma Questionnaire

    Time frame: Baseline 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 outcomes

  1. Physical symptoms: Patient Health Questionnaire

    Time frame: Baseline to 4 months

    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.

  2. Depression symptoms: Beck Depression Inventory II

    Time frame: Baseline 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.

  3. Quality of sleep: Karolinska Institute Sleep Questionnaire

    Time frame: Baseline to 4 months

    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.

  4. Daily functioning

    Time frame: Baseline to 4 months

    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.

  5. Post traumatic growth: Post Traumatic Growth Inventory

    Time frame: Baseline to 4 months

    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.

  6. General Psychological Well-being: WHO Well-being Index

    Time frame: Baseline to 4 months

    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.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 2, 2011
Registry last updated
Jun 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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