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Immunological Changes Through Narrative Treatment of Post-Traumatic Stress Disorder (PTSD) in Torture Victims

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206790
First Posted: September 22, 2010
Last Update Posted: February 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Iris-Tatjana Kolassa, University of Ulm
  Purpose
Posttraumatic stress disorder (PTSD) is associated with poor health, high health care utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune diseases. Research, including our own findings, indicates immunological alterations in PTSD patients. The aim of this study is to investigate whether alterations in the immune system of PTSD patients are reversible through a trauma-specific short-term therapy (Narrative Exposure Therapy).

Condition Intervention
PTSD Behavioral: NET

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immunological Changes Through Narrative Treatment of PTSD in Torture Victims

Resource links provided by NLM:


Further study details as provided by Iris-Tatjana Kolassa, University of Ulm:

Primary Outcome Measures:
  • PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) [ Time Frame: 4 month after completion of treatment ]

Secondary Outcome Measures:
  • changes in immunological parameters [ Time Frame: 4 months after completion of treatment ]

Enrollment: 47
Study Start Date: June 2009
Study Completion Date: January 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Narrative Exposure Therapy (NET) Behavioral: NET
Narrative Exposure Therapy for traumatized survivors of organized violence
No Intervention: Waitinglist Control Group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PTSD diagnosis
  • experiences of organized violence/torture

Exclusion Criteria:

  • psychotic disorder
  • chronic inflammatory diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206790


Locations
Germany
University of Konstanz, Department of Psychology
Konstanz, Germany, 78467
Sponsors and Collaborators
University of Konstanz
German Research Foundation
Investigators
Principal Investigator: Iris-Tatjana Kolassa, Prof. Dr. University of Ulm
  More Information

Responsible Party: Iris-Tatjana Kolassa, Prof. Dr. Iris-Tatjana Kolassa, University of Ulm
ClinicalTrials.gov Identifier: NCT01206790     History of Changes
Other Study ID Numbers: NET-2010-KN
First Submitted: September 21, 2010
First Posted: September 22, 2010
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Iris-Tatjana Kolassa, University of Ulm:
PTSD
Narrative Exposure Therapy
torture victims
immune system

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders