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

February 21, 2012 updated by: Iris-Tatjana Kolassa, University of Konstanz

Immunological Changes Through Narrative Treatment of PTSD in Torture Victims

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Konstanz, Germany, 78467
        • University of Konstanz, Department of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • PTSD diagnosis
  • experiences of organized violence/torture

Exclusion Criteria:

  • psychotic disorder
  • chronic inflammatory diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Narrative Exposure Therapy (NET)
Behavioral: NET
Narrative Exposure Therapy for traumatized survivors of organized violence
No Intervention: Waitinglist Control Group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in immunological parameters
Time Frame: 4 months after completion of treatment
4 months after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Konstanz

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Iris-Tatjana Kolassa, Prof. Dr., University of Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 21, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NET-2010-KN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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