Back to resultsImmunological Changes Through Narrative Treatment of Post-Traumatic Stress Disorder (PTSD) in Torture Victims
Primary Purpose
PTSD
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
NET
Sponsored by
About this trial
This is an interventional treatment trial for PTSD focused on measuring PTSD, Narrative Exposure Therapy, torture victims, immune system
Eligibility Criteria
Inclusion Criteria:
- PTSD diagnosis
- experiences of organized violence/torture
Exclusion Criteria:
- psychotic disorder
- chronic inflammatory diseases
Sites / Locations
- University of Konstanz, Department of Psychology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Narrative Exposure Therapy (NET)
Waitinglist Control Group
Arm Description
Outcomes
Primary Outcome Measures
PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS)
Secondary Outcome Measures
changes in immunological parameters
Full Information
NCT ID
NCT01206790
First Posted
September 21, 2010
Last Updated
February 21, 2012
Sponsor
University of Konstanz
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01206790
Brief Title
Immunological Changes Through Narrative Treatment of Post-Traumatic Stress Disorder (PTSD) in Torture Victims
Official Title
Immunological Changes Through Narrative Treatment of PTSD in Torture Victims
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, Narrative Exposure Therapy, torture victims, immune system
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Narrative Exposure Therapy (NET)
Arm Type
Experimental
Arm Title
Waitinglist Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
NET
Intervention Description
Narrative Exposure Therapy for traumatized survivors of organized violence
Primary Outcome Measure Information:
Title
PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS)
Time Frame
4 month after completion of treatment
Secondary Outcome Measure Information:
Title
changes in immunological parameters
Time Frame
4 months after completion of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PTSD diagnosis
experiences of organized violence/torture
Exclusion Criteria:
psychotic disorder
chronic inflammatory diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris-Tatjana Kolassa, Prof. Dr.
Organizational Affiliation
University of Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Konstanz, Department of Psychology
City
Konstanz
ZIP/Postal Code
78467
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Immunological Changes Through Narrative Treatment of Post-Traumatic Stress Disorder (PTSD) in Torture Victims
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