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

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Iris-Tatjana Kolassa, University of Ulm
ClinicalTrials.gov Identifier:
NCT01206790
First received: September 21, 2010
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immunological Changes Through Narrative Treatment of PTSD in Torture Victims

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Konstanz:

Primary Outcome Measures:
  • PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) [ Time Frame: 4 month after completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in immunological parameters [ Time Frame: 4 months after completion of treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PTSD diagnosis
  • experiences of organized violence/torture

Exclusion Criteria:

  • psychotic disorder
  • chronic inflammatory diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 21, 2010
Last Updated: February 21, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Konstanz:
PTSD
Narrative Exposure Therapy
torture victims
immune system

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

ClinicalTrials.gov processed this record on May 19, 2013