Stress Reduction in Middle Eastern Refugees

NCT01288690 | Completed Phase 2

• 1 other identifier: WSU082810B3F
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Refugees; Trauma; Narrative; Exposure; Middle East; Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Physical symptoms: Patient Health Questionnaire

  Baseline to 4 months

• Depression symptoms: Beck Depression Inventory II

  Baseline to 4 months.

• Quality of sleep: Karolinska Institute Sleep Questionnaire

  Baseline to 4 months

• Daily functioning

  Baseline to 4 months

• Post traumatic growth: Post Traumatic Growth Inventory

  Baseline to 4 months

Study Arms (2)

Wait List Control

NO INTERVENTION

This condition is a wait-list control and receives no intervention during the study period, but is offered treatment after the final assessment.

Narrative Exposure Therapy

EXPERIMENTAL

Patients in this condition receive 3 sessions of Narrative Exposure Therapy

Behavioral: Narrative Exposure Therapy

Interventions

Narrative Exposure Therapy BEHAVIORAL

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

Narrative Exposure Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Currently received exposure therapy for PTSD
• Planning to leave area in next 4 months

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48209, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries; Narration

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Communication; Behavior

Study Officials

• Mark A Lumley, Ph.D

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: February 2, 2011
• Study Start: December 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 17, 2013

Record last verified: 2013-06

Locations

US (1)