Stress Reduction in Middle Eastern Refugees

Post Traumatic Stress Disorder Clinical Trial

Official title:

Stress Reduction in Middle Eastern Refugees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288690
• Other study ID #: WSU082810B3F
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2011
• Last updated: June 13, 2013
• Start date: December 2010
• Est. completion date: August 2012

Study information

• Verified date: June 2013
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Narrative Exposure Therapy
3, 1-1/2 hour sessions, individual, meeting weekly.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No