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

PTSD Clinical Trial

Official title:

Immunological Changes Through Narrative Treatment of PTSD in Torture Victims

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206790
• Other study ID #: NET-2010-KN
• Status: Completed
• Phase: N/A
• First received: September 21, 2010
• Last updated: February 21, 2012
• Start date: June 2009
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• PTSD diagnosis

• experiences of organized violence/torture

Exclusion Criteria:

• psychotic disorder

• chronic inflammatory diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• NET
Narrative Exposure Therapy for traumatized survivors of organized violence

Locations

Country	Name	City	State
Germany	University of Konstanz, Department of Psychology	Konstanz

Sponsors (2)

Lead Sponsor	Collaborator
University of Konstanz	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS)		4 month after completion of treatment	No
Secondary	changes in immunological parameters		4 months after completion of treatment	No